Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 3:25 AM
Study NCT ID:
NCT07463092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'C008315', 'term': 'maltodextrin'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both participants and investigators are blinded to group assignment, managed by an external researcher. The supplements are identical in appearance, taste, and caloric content.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-group parallel assignment comparing creatine supplementation with resistance training versus placebo with resistance training for 12 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Density (Ultrasound-derived Echo Intensity and Thickness)', 'timeFrame': 'Baseline and 12 weeks.', 'description': 'Muscle density will be assessed using ultrasound-derived measurements, including muscle thickness and echo intensity of selected muscle groups. Higher muscle density reflects improved muscle quality.'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'Baseline and 12 weeks.', 'description': 'Muscle strength will be assessed using a handgrip dynamometer. The higher value of three attempts will be used.'}, {'measure': 'Muscle mass', 'timeFrame': 'Baseline and 12 weeks.', 'description': 'Muscle mass will be assessed using Dual-energy X-ray absorptiometry (DXA).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Androgen Deprivation Therapy', 'Creatine', 'Resistance Training', 'Muscle Density', 'Sarcopenia'], 'conditions': ['Prostate Cancer', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '37680229', 'type': 'RESULT', 'citation': 'Yuan F, Wang Y, Xiao X, Zhang X, Jing M, Kamecki H, Tan YG, Barreras SG, Aragon-Ching JB, Ma Z, Zhang P, Chang D, You Y. A systematic review evaluating the effectiveness of exercise training on physical condition in prostate cancer patients undergoing androgen deprivation therapy. Transl Androl Urol. 2023 Aug 31;12(8):1336-1350. doi: 10.21037/tau-23-272. Epub 2023 Aug 4.'}, {'type': 'RESULT', 'citation': 'McTiernan A,Friedenreich CM,Katzmarzyk PT,Powell KE,Macko R,Buchner D,Pescatello LS,Bloodgood B,Tennant B,Vaux-Bjerke A,George SM,Troiano RP,Piercy KL,2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*'}, {'pmid': '37482497', 'type': 'RESULT', 'citation': 'Kovac MB, Pavlin T, Cavka L, Ribnikar D, Spazzapan S, Templeton AJ, Seruga B. The trajectory of sarcopenia following diagnosis of prostate cancer: A systematic review and meta-analysis. J Geriatr Oncol. 2023 Sep;14(7):101594. doi: 10.1016/j.jgo.2023.101594. Epub 2023 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled clinical trial will investigate the effects of creatine supplementation combined with a 12-week supervised resistance training program on muscle mass, muscle strength, physical performance (e.g., parameters of sarcopenia), and muscle density in men with prostate cancer undergoing androgen deprivation therapy (ADT). ADT often causes loss of lean mass, reduced muscle strength, functional impairment, and increased fat mass. Eligible male patients will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) in a double-blind manner, in addition to participating in the resistance exercise program. Assessments will be performed at baseline and after the 12-week intervention period and will include:\n\n* Muscle density and architecture assessed by ultrasound\n* Body composition (lean mass and fat mass)\n* Muscle strength\n* Physical performance (functional performance tests)\n* Inflammatory biomarkers\n* Vascular function parameters\n\nThe primary goal is to assess whether creatine supplementation combined with resistance training can safely improve muscle quality and quantity, strength, and physical function in these patients. If effective and safe, the intervention could help reduce muscle loss and improve quality of life in men undergoing ADT.', 'detailedDescription': 'Men receiving androgen-deprivation therapy (ADT) for prostate cancer often experience significant loss of muscle mass, reduction in muscle strength, and increased fat mass. These changes can lead to sarcopenia, poorer physical function, and lower quality of life. Resistance training is known to improve muscle mass and strength in this population, but it is not clear whether adding creatine supplementation can further enhance these benefits. This study will investigate whether combining creatine monohydrate supplementation with a 12-week supervised resistance training program leads to greater improvements in muscle health compared to resistance training alone. Creatine is a nutritional supplement that may help increase muscle energy availability and support muscle growth and function, but its effects in men undergoing ADT have not been fully established. Participants will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) once daily throughout the 12-week resistance training program. All patients will follow the same structured resistance exercise protocol, supervised by trained professionals. The study will evaluate changes in muscle mass, muscle strength, physical performance, muscle density measured by ultrasound, inflammatory markers, vascular function, and other indicators of muscle health. The goal of this study is to determine whether creatine supplementation is a safe and effective strategy to improve muscle quality, physical function, and overall health for men receiving ADT. Findings from this trial may help guide future recommendations for exercise and nutritional support in this population.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged ≥ 40 years;\n* Patients with histologically or cytologically confirmed localized prostate cancer;\n* Patients who have undergone surgical castration or pharmacological castration with gonadotropin-releasing hormone (GnRH/LHRH) agonists or antagonists for at least six months prior to the start of the intervention;\n* Patients receiving continuous or intermittent androgen deprivation therapy;\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Not engaged in resistance training in the three months prior to the intervention;\n* Not using creatine supplementation in the three months prior to the intervention;\n* Willing to participate in a 12-week intervention consisting of resistance training performed three times per week and daily supplementation with creatine monohydrate or maltodextrin.\n\nExclusion Criteria:\n\n* Patients with insulin-dependent diabetes mellitus;\n* Patients with dialysis-dependent renal failure;\n* Patients with severe chronic liver disease;\n* Estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73 m²;\n* Any hormonal treatment outside that established by the medical team;\n* Patients planning to undergo chemotherapy within the next six months.'}, 'identificationModule': {'nctId': 'NCT07463092', 'briefTitle': 'Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy', 'orgStudyIdInfo': {'id': '89367125.1.3001.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creatine Supplementation + Resistance Training', 'description': 'Participants assigned to the experimental arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of creatine monohydrate. Creatine supplementation will be administered daily throughout the intervention period.', 'interventionNames': ['Dietary Supplement: Creatine Monohydrate', 'Behavioral: Resistance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo (Maltodextrin) + Resistance Training', 'description': 'Participants assigned to the control arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of maltodextrin. Maltodextrin will be administered daily throughout the intervention period.', 'interventionNames': ['Dietary Supplement: Maltodextrin', 'Behavioral: Resistance training']}], 'interventions': [{'name': 'Creatine Monohydrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will receive 5 g/day of creatine monohydrate throughout the 12-week supervised resistance training program.', 'armGroupLabels': ['Creatine Supplementation + Resistance Training']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will receive 5 g/day of maltodextrin, matched in appearance and caloric content to creatine, throughout the 12-week supervised resistance training program.', 'armGroupLabels': ['Placebo (Maltodextrin) + Resistance Training']}, {'name': 'Resistance training', 'type': 'BEHAVIORAL', 'otherNames': ['Strength training', 'Supervised resistance training', 'Progressive resistance training'], 'description': 'Participants will complete a 12-week supervised, progressive resistance training program designed to improve muscle strength and muscle mass. Training sessions will be conducted under professional supervision and will occur three times per week. The program will target major muscle groups of the upper and lower body using weight machines and free weights. All participants in both study arms will follow the same resistance training protocol.', 'armGroupLabels': ['Creatine Supplementation + Resistance Training', 'Placebo (Maltodextrin) + Resistance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Guilherme WP da Fonseca, PhD', 'role': 'CONTACT', 'email': 'guilhermefonseca@usp.br', 'phone': '+55 11 3091 2137'}, {'name': 'Comitê de Ética em Pesquisa da EEFE-USP', 'role': 'CONTACT', 'email': 'cep39@usp.br', 'phone': '+55 11 3091 3097'}, {'name': 'Guilherme WP da Fonseca, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'School of Physical Education and Sport - USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Guilherme WP da Fonseca, PhD', 'role': 'CONTACT', 'email': 'guilhermefonseca@usp.br', 'phone': '+55 11 3091 2137'}, {'name': 'Comitê de Ética em Pesquisa da EEFE-USP', 'role': 'CONTACT', 'email': 'cep39@usp.br', 'phone': '+55 11 3091 3097'}], 'overallOfficials': [{'name': 'Guilherme WP da Fonseca, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Physical Education and Sport - USP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Decision has not been made yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'InCor Heart Institute', 'class': 'OTHER'}, {'name': 'Medical school of the University of São Paulo (FMUSP)', 'class': 'UNKNOWN'}, {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guilherme Wesley Peixoto da Fonseca', 'investigatorAffiliation': 'University of Sao Paulo'}}}}