Clinical trial · Interventional
Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
NCT03880422CI-TRIAL-00110766recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.
Conditions
Conditions (20)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage A Prostate Cancer | — | UNRESOLVED | — |
| Stage B Prostate Cancer | — | UNRESOLVED | — |
| Stage C Prostate Cancer | — | UNRESOLVED | — |
| Stage D Prostate Cancer | — | UNRESOLVED | — |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intervention | Dietary Supplement | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (diet, exercise, education)
- description
- Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
- interventionNames
- Dietary Supplement: Dietary Intervention
- Other: Educational Intervention
- Behavioral: Exercise Intervention
- Other: Quality-of-Life Assessment
- Other: Survey Administration
Primary outcomes (1)
- measure
- Changes in body composition
- timeFrame
- Baseline up to 6 months
- description
- Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-confirmed prostate adenocarcinoma of any stage/grade * Prescribed or already receiving continuous ADT for \< 5 years * Hemoglobin \> 11 g/dL * Creatinine \< 1.5 x upper limit of normal (ULN), AST or ALT \<2 x ULN within 6 months prior to enrollment * Liver function tests \< 2 x ULN * Able to walk unassisted at least 100 meters (200 steps) or ECOG \<= 1 * No contraindications to any aspect of participation, including aerobic exercise * Participant must be able to read, write, and understand the English language and be able to provide written consent * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias * Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion) * Overall medical frailty (clinician discretion) * Any condition contraindicating additional blood collection beyond standard of care * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention
References
Publications (0)
Data not yet available
No reference posted for this study.