Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:18 AM
Study NCT ID:
NCT07408505
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, controlled, prospective, multicenter study evaluating nano-crystalline megestrol acetate plus first-line chemotherapy in patients with advanced pancreatic cancer-related anorexia-cachexia syndrome. Treatment-naïve patients with locally advanced or metastatic pancreatic ductal adenocarcinoma meeting pre-cachexia or cachexia criteria will be randomized 1:1 to receive nano-crystalline megestrol acetate (625 mg/day for up to 12 weeks) with chemotherapy or chemotherapy alone. The primary endpoint is ≥5% weight gain at Week 12. Secondary endpoints include appetite, OS, PFS, body composition, quality of life, and safety. Open-label follow-up is up to one year.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in C-reactive protein(mg/L)', 'timeFrame': '12 weeks', 'description': 'Exploratory analysis of changes from baseline in inflammatory marker C-reactive protein(mg/L) between the experimental arm (first-line therapy combined with nanocrystalline megestrol acetate) and the control arm (first-line therapy alone) in the blood of patients with advanced pancreatic cancer.'}, {'measure': 'Changes in neutrophil-to-lymphocyte ratio', 'timeFrame': '12 weeks', 'description': 'Exploratory analysis of changes from baseline in inflammatory marker neutrophil-to-lymphocyte ratio between the experimental arm (first-line therapy combined with nanocrystalline megestrol acetate) and the control arm (first-line therapy alone) in the blood of patients with advanced pancreatic cancer.'}, {'measure': 'Changes in cytokines (IL-1(pg/ml), IL-6(pg/ml), TNF-α(pg/ml))', 'timeFrame': '12 weeks', 'description': 'Exploratory analysis of changes from baseline in cytokines (IL-1(pg/ml), IL-6(pg/ml) and TNF-α(pg/ml)) between the experimental arm (first-line therapy combined with nanocrystalline megestrol acetate) and the control arm (first-line therapy alone) in the blood of patients with advanced pancreatic cancer.'}, {'measure': 'Changes in nutritional biomarkers (albumin(g/L), prealbumin(g/L), hemoglobin(g/L))', 'timeFrame': '12 weeks', 'description': 'Exploratory analysis of changes from baseline in nutritional biomarkers (albumin(g/L), prealbumin(g/L), hemoglobin(g/L)) between the experimental arm (first-line therapy combined with nanocrystalline megestrol acetate) and the control arm (first-line therapy alone) in the blood of patients with advanced pancreatic cancer.'}], 'primaryOutcomes': [{'measure': 'Proportion of Patients Achieving >5% Weight Gain From Baseline(weight in kilograms,Kg)', 'timeFrame': '12 weeks', 'description': 'The proportion of patients with advanced pancreatic cancer-related anorexia-cachexia syndrome who achieve a body weight increase of more than 5% compared with baseline(Kg) during first-line treatment combined with or without nano-crystalline megestrol acetate.'}], 'secondaryOutcomes': [{'measure': 'Change in Appetite Assessed by Functional Assessment of Anorexia/Cachexia Therapy-Anorexia/Cachexia Subscale (FAACT-A/CS 12)', 'timeFrame': '12 weeks', 'description': 'Change from baseline in appetite as assessed by the Functional Assessment of Anorexia/Cachexia Therapy-Anorexia/Cachexia Subscale (FAACT-A/CS 12) in patients with advanced pancreatic cancer.The A/CS-12 Scale maintains the reliability, validity, and assessment accuracy of the FAACT questionnaire while reducing the number of items from 18 to 12. Each item is scored from 0 to 4, with a total score ranging from 0 to 48. Lower scores indicate poorer appetite in patients. When using the A/CS-12 Scale, it is recommended to use a total score ≤ 37 as the criterion for determining appetite loss in patients.'}, {'measure': 'Change in Body Composition Assessed by L3-CT', 'timeFrame': '12 weeks', 'description': "Change from baseline in body composition parameters, including skeletal muscle and adipose tissue area, assessed by computed tomography at the third lumbar vertebra (L3) level.A single cross-sectional image of the third lumbar vertebra (L3) is obtained via CT/MRI scanning. The skeletal muscles (psoas major, erector spinae, quadratus lumborum, transversus abdominis, external oblique, internal oblique) and adipose tissue in the L3 image are identified and quantified. Image analysis software such as Slice-O-Matic or Image J is used to calculate the total skeletal muscle area(skeletal muscle area in square centimeters,cm²) at this level. This area is then divided by the square of the patient's height(height in meters,m) to obtain the L3 Skeletal Muscle Index (L3-SMI,L3-SMI =skeletal muscle area (cm²) / (height(m))².Compare the changes in Skeletal Muscle Index (SMI) from baseline to the end of the study between the two groups (Megestrol Acetate group vs. control group)."}, {'measure': 'Change in Physical Function Scale', 'timeFrame': '12 weeks', 'description': 'Change from baseline in physical function assessed using standardized functional assessment methods in patients with advanced pancreatic cancer.Physical Functioning Scale is assessed using a 4-point scale（from 1 to 4）, where a higher score on the functional scale indicates better function.'}, {'measure': 'Change in Quality of Life Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)', 'timeFrame': '12 weeks', 'description': 'Change from baseline in health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).The Overall Quality of Life Scale is divided into 7 levels, with scores ranging from 1 to 7. Higher scores indicate better overall quality of life.'}, {'measure': 'Incidence and Severity of Adverse Events', 'timeFrame': '12 weeks', 'description': 'Incidence, nature, and severity of adverse events and serious adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. NCI CTCAE version 5.0 classifies the severity of adverse events into Grades 1 through 5, with a higher grade indicating greater severity. Adverse events (AEs) for each subject will be followed up until 30 days after the last dose of nanocrystalline megestrol acetate or until the initiation of new antitumor therapy, whichever occurs first. Serious adverse events (SAEs) will be followed up until 90 days after the last dose or until the initiation of new antitumor therapy, whichever occurs first. Safety assessments of the drug will be conducted according to the schedule outlined in the study protocol, including a series of examinations such as vital signs, physical examinations, clinical laboratory evaluations, electrocardiograms (ECG), and echocardiograms.'}, {'measure': 'Chemotherapy Compliance', 'timeFrame': '12 weeks', 'description': 'Compliance with planned first-line chemotherapy regimens, assessed by dose intensity, treatment delays, and discontinuations during the study period.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '1 year', 'description': 'The time interval from enrollment to death from any cause for patients in the intent-to-treat population. For patients who were still alive at the time of analysis or lost to follow-up, the date of the last known survival status was used as the endpoint date.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '1 year', 'description': 'The time interval from enrollment to disease progression or death from any cause, whichever occurs first. For patients without documented progression at the time of study discontinuation, the date of the last tumor assessment will be used as the endpoint date.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': '1 year', 'description': 'The percentage of subjects in the intent-to-treat population who achieve a complete response (CR) or partial response (PR) as their best overall response according to RECIST 1.1 criteria during the study period.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': '1 year', 'description': 'The percentage of subjects in the intent-to-treat population who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 weeks, as assessed per RECIST 1.1 criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic ductal adenocarcinoma', 'Cancer anorexia-cachexia syndrome', 'Nanocrystalline megestrol acetate', 'Body weight and body composition', 'Appetite improvement'], 'conditions': ['Advanced Pancreatic Ductal Adenocarcinoma', 'Cancer Anorexia-Cachexia Syndrome']}, 'referencesModule': {'references': [{'pmid': '34550461', 'type': 'BACKGROUND', 'citation': 'Miyawaki T, Naito T, Yabe M, Kodama H, Nishioka N, Miyawaki E, Mamesaya N, Kobayashi H, Omori S, Wakuda K, Ono A, Kenmotsu H, Murakami H, Mori K, Harada H, Takahashi K, Takahashi T. Impact of weight loss on treatment with PD-1/PD-L1 inhibitors plus chemotherapy in advanced non-small-cell lung cancer. Support Care Cancer. 2022 Feb;30(2):1633-1641. doi: 10.1007/s00520-021-06572-4. Epub 2021 Sep 22.'}, {'pmid': '38240151', 'type': 'BACKGROUND', 'citation': 'Betts KA, Gao S, Ray S, Schoenfeld AJ. Real-world safety of first-line immuno-oncology combination therapies for advanced non-small-cell lung cancer. Future Oncol. 2024 Apr;20(13):851-862. doi: 10.2217/fon-2023-0612. Epub 2024 Jan 19.'}, {'pmid': '33607591', 'type': 'BACKGROUND', 'citation': 'Hariyanto TI, Kurniawan A. Appetite problem in cancer patients: Pathophysiology, diagnosis, and treatment. Cancer Treat Res Commun. 2021;27:100336. doi: 10.1016/j.ctarc.2021.100336. Epub 2021 Feb 13.'}, {'pmid': '35388147', 'type': 'BACKGROUND', 'citation': 'Yeom E, Yu K. Understanding the molecular basis of anorexia and tissue wasting in cancer cachexia. Exp Mol Med. 2022 Apr;54(4):426-432. doi: 10.1038/s12276-022-00752-w. Epub 2022 Apr 6.'}, {'pmid': '38511400', 'type': 'BACKGROUND', 'citation': 'Hong SH, Choi KM. Gut hormones and appetite regulation. Curr Opin Endocrinol Diabetes Obes. 2024 Jun 1;31(3):115-121. doi: 10.1097/MED.0000000000000859. Epub 2024 Mar 21.'}, {'pmid': '39016695', 'type': 'BACKGROUND', 'citation': 'Rubinic I, Kurtov M, Likic R. Novel Pharmaceuticals in Appetite Regulation: Exploring emerging gut peptides and their pharmacological prospects. Pharmacol Res Perspect. 2024 Aug;12(4):e1243. doi: 10.1002/prp2.1243.'}, {'pmid': '21296615', 'type': 'BACKGROUND', 'citation': 'Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.'}, {'pmid': '36806788', 'type': 'BACKGROUND', 'citation': 'Argiles JM, Lopez-Soriano FJ, Stemmler B, Busquets S. Cancer-associated cachexia - understanding the tumour macroenvironment and microenvironment to improve management. Nat Rev Clin Oncol. 2023 Apr;20(4):250-264. doi: 10.1038/s41571-023-00734-5. Epub 2023 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'Cancer anorexia-cachexia syndrome is a common and severe complication in patients with advanced cancer, with a particularly high prevalence in pancreatic cancer. It is associated with systemic inflammation, metabolic disturbances, and dysregulation of central appetite control, leading to reduced quality of life, poor tolerance to anticancer therapy, and shortened survival. Anticancer treatments, including chemotherapy and immunotherapy, may further exacerbate the development and progression of cachexia.\n\nMegestrol acetate is recommended as a first-line treatment for cancer-related anorexia-cachexia syndrome by multiple international and national guidelines, based on its proven effects on appetite stimulation, weight gain, and quality of life improvement. The nanocrystalline formulation of megestrol acetate significantly enhances bioavailability and achieves effective plasma concentrations even in the fasting state, making it particularly suitable for patients with cancer cachexia.\n\nThis randomized, controlled, prospective study aims to evaluate the efficacy and safety of nanocrystalline megestrol acetate in patients with advanced pancreatic cancer complicated by cancer anorexia-cachexia syndrome. The study will assess improvements in appetite, body weight, nutritional status, and quality of life, and explore the clinical value of early anti-cachexia intervention in the era of immuno-chemotherapy, providing evidence to optimize comprehensive treatment strategies for advanced pancreatic cancer.', 'detailedDescription': 'This is a multicenter, randomized, controlled, prospective interventional clinical study evaluating an approved formulation of nanocrystalline megestrol acetate oral suspension. The study aims to assess the efficacy and safety of nanocrystalline megestrol acetate in combination with standard first-line therapy versus standard first-line therapy alone in newly diagnosed patients with locally advanced or metastatic pancreatic ductal adenocarcinoma with cancer anorexia-cachexia syndrome, and to explore its impact on survival outcomes, quality of life, and selected biomarkers.\n\nPatients with pancreatic cancer have a high prevalence of malnutrition and cachexia. Treatment-related adverse effects from chemotherapy and immunotherapy may further worsen anorexia, weight loss, and skeletal muscle wasting, creating a vicious cycle that compromises treatment tolerance, quality of life, and prognosis. Although megestrol acetate is widely recommended as a first-line pharmacologic option for cancer-related anorexia-cachexia syndrome by multiple guidelines, prospective evidence regarding the optimal timing and the overall clinical benefit of combining megestrol acetate with contemporary first-line regimens (including immuno-chemotherapy) remains limited. The nanocrystalline formulation improves bioavailability through particle-size reduction and can achieve effective plasma exposure even in the fasting state, which may be particularly advantageous for patients with reduced oral intake.\n\nEligible participants will be stratified by pre-cachexia versus cachexia, and randomized with stratification factors including ECOG performance status (0-1 vs 2) and planned chemotherapy regimen (AG vs mFOLFIRINOX/NALIRIFOX). Participants will be assigned to one of two arms:\n\n1. Megestrol arm: nanocrystalline megestrol acetate 625 mg/day (125 mg/mL, 5 mL orally once daily) initiated at the start of first-line therapy and continued for up to 12 weeks, in addition to investigator-selected standard first-line systemic therapy per guidelines and routine practice (e.g., AG, FOLFIRINOX, or NALIRIFOX, with or without immunotherapy as applicable);\n2. Control arm: standard first-line systemic therapy alone. If the primary anticancer regimen is modified, interrupted, or permanently discontinued during the study, nanocrystalline megestrol acetate may continue in the combination arm (per protocol) until completion of the 12-week course, allowing evaluation of the core anti-cachexia intervention.\n\nThe primary assessment focuses on the proportion of patients achieving \\>5% body-weight gain from baseline at Week 12 (as a key primary endpoint within the dual-endpoint framework), along with comprehensive evaluation of appetite (FAACT-A/CS 12), body composition (L3-level CT-based assessment of skeletal muscle and adipose tissue), physical function, health-related quality of life (EORTC QLQ-C30), chemotherapy adherence, and the incidence and severity of adverse events. Tumor response will be assessed at predefined intervals (approximately every 6 weeks), and survival outcomes including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) will be followed and analyzed up to one year after randomization. In addition, the study will explore changes in inflammatory markers (CRP, NLR), cytokines (IL-1, IL-6, TNF-α), and nutritional indices (albumin, prealbumin, hemoglobin) from baseline to Week 12 to support mechanistic understanding and identify potential predictive biomarkers.\n\nSafety will be monitored continuously throughout the study, with standardized collection and follow-up of adverse events (AEs) and serious adverse events (SAEs) as specified in the protocol, complemented by vital signs, physical examinations, laboratory testing, electrocardiography, and echocardiography. Overall, this study aims to validate an integrated strategy combining anticancer therapy with early anti-cachexia intervention in the immuno-chemotherapy era, and to generate high-quality evidence on the clinical value of nanocrystalline megestrol acetate in improving weight/body composition, symptom burden, quality of life, and potentially survival outcomes in advanced pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be eligible for enrollment:\n\n 1\\. Pancreatic cancer-specific inclusion criteria:\n 1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma according to the TNM staging system of the International Association of Pancreatology and the 8th edition of the American Joint Committee on Cancer (AJCC);\n 2. No prior systemic antitumor therapy for recurrent or metastatic disease;\n 3. Prior adjuvant or neoadjuvant chemotherapy, radiotherapy, chemoradiotherapy, or immunotherapy for non-metastatic disease is allowed, provided that at least 6 months have elapsed since completion of the last treatment without disease recurrence;\n 4. At least one measurable lesion according to RECIST version 1.1 (previously irradiated lesions may be considered measurable only if there is clear evidence of disease progression after radiotherapy).\n\n 2\\. Fulfillment of Fearon criteria for cachexia or pre-cachexia:\n\n (1) Cachexia stage according to Fearon criteria: fulfillment of any of the following criteria in combination with decreased appetite (FAACT-A/CS 12 score ≤ 37) or systemic inflammation (CRP \\> 5 mg/L):\n\n ① Unintentional weight loss \\> 5% within the past 6 months;\n * Body weight loss \\> 2% in patients with a BMI \\< 18.5 kg/m². (2) Pre-cachexia stage according to Fearon criteria: all of the following three conditions must be met:\n\n ① Unintentional weight loss ≤ 5% within the past 6 months;\n * Systemic inflammation (CRP \\> 5 mg/L);\n\n ③ Decreased appetite (FAACT-A/CS 12 score ≤ 37). 3. General inclusion criteria:\n 1. Good compliance and provision of written informed consent;\n 2. Age 18-75 years, regardless of sex;\n 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n 4. Expected survival greater than 4 months;\n 5. Adequate organ function, defined as follows:\n\n • Hematologic function: absolute neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 9 g/dL, platelet count ≥ 100 × 10⁹/L;\n\n • Hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's syndrome may be enrolled if serum bilirubin ≤ 3 × ULN), AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases), and alkaline phosphatase ≤ 3 × ULN (≤ 5 × ULN in the presence of liver or bone metastases); serum albumin ≥ 3 g/dL;\n\n • Coagulation function: international normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;\n\n • Renal function: creatinine clearance ≥ 60 mL/min as calculated by the Cockcroft-Gault formula;\n * Urinary protein: urine protein ≤ 1+ on dipstick or 24-hour urine protein \\< 1.0 g;\n * Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%.\n 6. Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to first dosing (if a urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required and shall prevail). Women of childbearing potential who engage in sexual activity with non-sterilized male partners must use an acceptable method of contraception from screening and agree to continue contraception for 120 days after the last dose of study medication; decisions regarding discontinuation of contraception after this time point should be discussed with the investigator. Male patients who engage in sexual activity with women of childbearing potential must use effective contraception from screening until 120 days after the last dose of study medication; decisions regarding discontinuation of contraception after this time point should be discussed with the investigator.\n\n Exclusion Criteria:\n* Patients meeting any of the following criteria will be excluded from this study:\n\n 1\\. Cancer-specific exclusion criteria:\n 1. Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) during screening or based on prior imaging assessments. Patients with previously treated brain or leptomeningeal metastases may be eligible if the disease has been stable for ≥ 2 months and systemic corticosteroid therapy (\\>10 mg/day prednisone or equivalent) has been discontinued for \\> 4 weeks prior to randomization.\n 2. Uncontrolled tumor-related pain;\n\n (1) History of thromboembolic disease, ascites, or lower extremity edema within the past 6 months; (3) History of malignancy other than pancreatic cancer within 5 years prior to randomization, except for malignancies with negligible risk of metastasis or death (e.g., expected 5-year overall survival \\> 90%) and considered curable after appropriate treatment, such as adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative surgery, and ductal carcinoma in situ treated with curative surgery; (4) Unresolved toxicity from prior anticancer therapy, defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia) or failure to recover to levels specified in the inclusion/exclusion criteria; (5) Patients with peritoneal metastases will be excluded. 2. General medical exclusion criteria:\n 1. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;\n 2. Patients with hepatitis B or hepatitis C:\n\n ① Patients with a history of hepatitis B virus (HBV) infection must undergo HBV deoxyribonucleic acid (DNA) testing; only patients with negative HBV DNA (HBV DNA \\< 1000 copies/mL or \\< 200 IU/mL or below the upper limit of normal) are eligible for participation in this study;\n\n ② Among patients who are positive for hepatitis C virus (HCV) antibodies, only those with negative HCV ribonucleic acid (RNA) by polymerase chain reaction (PCR) testing are eligible to participate in this study;\n 3. Patients with a positive test result for human immunodeficiency virus (HIV);\n 4. Major surgery (excluding diagnostic procedures) within 28 days prior to randomization, or anticipated major surgery during the study period;\n 5. Significant cardiovascular disease, such as heart disease defined as New York Heart Association class II or higher, myocardial infarction within 3 months prior to randomization, unstable arrhythmia, unstable angina, cerebrovascular accident, or transient ischemic attack. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \\< 50% must be receiving optimal stable therapy as determined by the treating physician; consultation with a cardiologist may be obtained if necessary;\n 6. Severe infection occurring within 4 weeks prior to first dosing, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks prior to first dosing (excluding antiviral therapy for hepatitis B or C).\n\n 3\\. Drug-related exclusion criteria:\n 1. Conditions affecting gastrointestinal absorption, including dysphagia, malabsorption, or uncontrolled vomiting; difficulty in food intake or requirement for tube feeding or parenteral nutrition; anorexia nervosa; anorexia caused by psychiatric disorders or pain-related inability to eat;\n 2. Current or planned use of other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone use during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants;\n 3. Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus; or current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite treatment with oral antihypertensive agents;\n 4. History within 6 months prior to first dosing of esophageal or gastric varices, severe ulcer disease, gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding;\n 5. Known hypersensitivity to any component of the study drug;\n 6. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study."}, 'identificationModule': {'nctId': 'NCT07408505', 'briefTitle': 'Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'Efficacy and Safety of Nano-Megestrol Acetate in the Treatment of Anorexia-Cachexia Syndrome in Patients With Advanced Pancreatic Cancer: A Randomized, Controlled, Prospective Study', 'orgStudyIdInfo': {'id': 'SDZLEC2025-481-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nano-crystalline Megestrol Acetate Group', 'description': 'Participants assigned to the experimental arm will receive nano-crystalline megestrol acetate oral suspension in combination with first-line chemotherapy. Nano-crystalline megestrol acetate will be administered orally at a dose of 625 mg once daily (5 mL, 125 mg/mL), starting on the first day of chemotherapy and continued for up to 12 weeks. First-line chemotherapy will be selected by the investigator according to clinical guidelines and practice, including AG, FOLFIRINOX, or NALIRIFOX regimens. If the primary antitumor treatment is modified, delayed, or discontinued during the study, nano-crystalline megestrol acetate may be continued until completion of the 12-week treatment period. Patients will be followed for efficacy and safety assessments according to the study protocol.', 'interventionNames': ['Drug: Nano-crystalline megestrol acetate', 'Drug: First-line Chemotherapy']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Participants assigned to the control group will receive first-line chemotherapy alone, without nano-crystalline megestrol acetate. First-line chemotherapy will be selected by the investigator according to clinical guidelines and standard clinical practice, including AG, FOLFIRINOX, or NALIRIFOX regimens. Chemotherapy dosing, schedule, and modifications will be managed according to routine clinical practice and institutional standards. Participants will be followed for efficacy and safety assessments according to the study protocol.', 'interventionNames': ['Drug: First-line Chemotherapy']}], 'interventions': [{'name': 'Nano-crystalline megestrol acetate', 'type': 'DRUG', 'description': 'Nano-crystalline megestrol acetate is administered as an oral suspension at a dose of 625 mg once daily (5 mL, 125 mg/mL) starting concurrently with first-line chemotherapy and continued for up to 12 weeks. Unlike conventional megestrol acetate formulations, the nano-crystalline formulation utilizes reduced particle size to enhance oral bioavailability and improve weight gain outcomes. In this study, nano-crystalline megestrol acetate is used as an early supportive intervention in treatment-naïve patients with advanced pancreatic cancer-related anorexia-cachexia syndrome, rather than as salvage therapy. The intervention is delivered in combination with standard first-line chemotherapy regimens (AG, FOLFIRINOX, or NALIRIFOX). Administration of nano-crystalline megestrol acetate may be continued even if modifications, delays, or discontinuation of chemotherapy occur, in accordance with the study protocol. Safety and efficacy are prospectively monitored throughout treatment and follow-up.', 'armGroupLabels': ['Nano-crystalline Megestrol Acetate Group']}, {'name': 'First-line Chemotherapy', 'type': 'DRUG', 'description': 'Participants in the control group will receive first-line chemotherapy alone, without nano-crystalline megestrol acetate. Chemotherapy regimens, including AG, FOLFIRINOX, or NALIRIFOX, will be selected and managed according to standard clinical practice.', 'armGroupLabels': ['Control Group', 'Nano-crystalline Megestrol Acetate Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinbo Yue, Doctor', 'role': 'CONTACT', 'email': 'jbyue@sdfmu.edu.cn', 'phone': '0531-67626442'}], 'facility': 'Jinan, Shandong 0531', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Jinbo Yue, Dorcter', 'role': 'CONTACT', 'email': 'jbyue@sdfmu.edu.cn', 'phone': '0531-67626442'}], 'overallOfficials': [{'name': 'Jinbo Yue, Dorcter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Cancer Hospital and Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Radiation Oncology Department', 'investigatorFullName': 'Jinbo Yue', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}