Clinical trial · Interventional
Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance
- 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 clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance. Intensive lifestyle interventions that recommend modest reductions in daily caloric intake (i.e. continuous calorie energy reduction \[CER\]) are the gold-standard for weight loss, and have been tested in cancer survivors, including prostate cancer patients. However, few interventions have been developed for low-risk prostate cancer patients on active surveillance. Intermittent fasting (IF) may be superior to CER in the context of prostate cancer progression given its dual role in weight loss and metabolic switching from the use of glucose as a fuel source to the use of fatty acids and ketone bodies. This study may help researchers determine which weight loss strategies can reduce their risk of prostate cancer recurrence, and other negative health effects of being overweight or obese.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dietary Intervention | Other | — | UNRESOLVED |
| Fasting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (CER)
- description
- Patients undergo CER intervention consisting of remote lesson containing information and behavioral strategies about weight loss, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo collection of blood samples throughout the trial.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Dietary Intervention
- type
- EXPERIMENTAL
- label
- Arm II (IF)
- description
- Patients undergo IF intervention consisting of remote lesson containing information and behavioral strategies about fasting, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo fasting 2 days per week and eat according to the NCI guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Dietary Intervention
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years old or older (no upper limit) * Body mass index (BMI) \>= 25 kg/m\^2 * English speaking * Not currently on weight loss medications * Prostate cancer patients who are under active surveillance (including observation) and actively followed at Roswell Park * Not under active treatment for other cancer diagnosis * Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component * Has not lost at least 10% of their body weight in the last 6 months * Has not had bariatric surgery in the last 10 years * Able to walk unassisted and continuously for 10 minutes * 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: * Unable to consent * Unwilling or unable to follow protocol requirements * Unable to complete study measures in English * Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study * Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study * History of partial or radical prostatectomy
References
Publications (0)
Data not yet available