Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 12:13 AM
Study NCT ID:
NCT06311357
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2023-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percent Weight Change in the Medical Supplement Group of Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent weight change', 'timeFrame': '12 weeks', 'description': 'The change of body weight (%) before and after chemotherapy treatment'}], 'secondaryOutcomes': [{'measure': 'EORTC QLQ-C30', 'timeFrame': '12 weeks', 'description': 'The change of Global Quality of life before and after chemotherapy treatment score'}, {'measure': 'Patient interpretation of the Patient-Generated Subjective Global Assessment', 'timeFrame': '12 weeks', 'description': 'PG-SGA'}, {'measure': 'EORTC QLQ-BR23', 'timeFrame': '12 weeks', 'description': 'The change of Global Quality of life before and after chemotherapy treatment score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical supplement', 'Weight change in early breast cancer treatment'], 'conditions': ['Early Stage Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '33946039', 'type': 'BACKGROUND', 'citation': 'Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.'}, {'pmid': '24748626', 'type': 'BACKGROUND', 'citation': 'Hebuterne X, Lemarie E, Michallet M, de Montreuil CB, Schneider SM, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):196-204. doi: 10.1177/0148607113502674.'}, {'pmid': '7424938', 'type': 'BACKGROUND', 'citation': 'Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.'}, {'pmid': '29952503', 'type': 'BACKGROUND', 'citation': 'Sukaraphat N, Chewaskulyong B, Buranapin S. Dietary Counseling Outcomes in Locally Advanced Unresectable or Metastatic Cancer Patients Undergoing Chemotherapy. J Med Assoc Thai. 2016 Dec;99(12):1283-90.'}, {'pmid': '8410128', 'type': 'BACKGROUND', 'citation': 'Ovesen L, Allingstrup L, Hannibal J, Mortensen EL, Hansen OP. Effect of dietary counseling on food intake, body weight, response rate, survival, and quality of life in cancer patients undergoing chemotherapy: a prospective, randomized study. J Clin Oncol. 1993 Oct;11(10):2043-9. doi: 10.1200/JCO.1993.11.10.2043.'}, {'pmid': '40106001', 'type': 'DERIVED', 'citation': 'Tienchaiananda P, Juntong M, Pintasiri P, Sa-Nguansai S, Payapwattanawong S, Maneenil K. Body weight change in a medical supplement group in patients with early breast cancer during chemotherapy: a randomized, controlled trial. Support Care Cancer. 2025 Mar 19;33(4):299. doi: 10.1007/s00520-025-09359-z.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).\n\nThe main question is\n\n• the change of weight (%) before and after complete treatment of breast cancer therapy.\n\nParticipants will be randomized into 2 group\n\n* intervention group - receive medical supplement daily during chemotherapy treatment.\n* control group - Nutritional advise during chemotherapy treatment.', 'detailedDescription': '1. The rational is to prove the hypothesis is that, the effect of medical supplement with nutritional advise can prevent the reduction of body weight, malnutrition and treatment complication, which eventually to improve of the quality of life.\n2. Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital. Secondary endpoints are nutritional status (PG-SGA), quality of life.\n3. Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 40 patients.\n4. Randomization into 2 groups. Intervention arm : receive medical supplement daily (1 drink = 6 scoops in 250 ml water, 2 drinks/day) with nutritional advise. Control arm : nutritional advise only. Duration of treatment is 12 weeks\n5. Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system.\n6. Data assessment on week 0,6,12 during chemotherapy treatment.\n7. Data analyzed by descriptive statistics to characterize patients at entry. We did the efficacy analyses with intention to treat population\n8. We did analyses with R version 3.3.0.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathological confirmed diagnosis of breast cancer\n* Breast cancer stage I-III\n* Recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at Rajavithi hospital\n* LVEF \\>= 60% - ECOG score 0-1\n\nExclusion Criteria:\n\n* No indication for chemotherapy\n* Contraindication for chemotherapy\n* Breast cancer stage IV\n* Diabetic mellitus who requires insulin injection\n* BMI \\>= 30 kg/m2 or \\<= 16 kg/m2\n* Previously known other malignancies\n* Second primary cancer\n* Previously received chemotherapy or radiotherapy\n* Severe malnutrition with administration of TPN is indicated\n* Pregnancy or lactation\n* CKD stage 4-5'}, 'identificationModule': {'nctId': 'NCT06311357', 'briefTitle': 'Percent Weight Change in the Medical Supplement Group of Early Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Effects of Body Weight Change in the Medical Supplement Group in Patients with Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '100/2566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Nutritional advise'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Medical supplement and nutritional advise', 'interventionNames': ['Dietary Supplement: Ensure']}], 'interventions': [{'name': 'Ensure', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Meitinarth Juntong', 'role': 'CONTACT', 'email': 'juntong.mei@gmail.com', 'phone': '+66654415447'}], 'facility': 'Rajavithi hospital', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'centralContacts': [{'name': 'Meitinarth Juntong', 'role': 'CONTACT', 'email': 'juntong.mei@gmail.com', 'phone': '+66654415447'}], 'overallOfficials': [{'name': 'Piyawan Tienchaiananda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Medical Services Ministry of Public Health of Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to this study is performed on single institution. The study protocol will be provided later on published article.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}