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Trial Title:
Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance
NCT ID:
NCT05764330
Condition:
Prostate Carcinoma
Conditions: Official terms:
Weight Loss
Disease Progression
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Arm I (CER)
Arm group label:
Arm II (IF)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Undergo CER intervention
Arm group label:
Arm I (CER)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Undergo IF intervention
Arm group label:
Arm II (IF)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Behavioral
Intervention name:
Fasting
Description:
Undergo fasting
Arm group label:
Arm II (IF)
Other name:
Fast
Summary:
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.
Detailed description:
PRIMARY OBJECTIVES:
I. Develop two evidence-based behavioral weight loss intervention programs (IF and CER)
with a goal to cause weight loss in prostate cancer (PCa) patients on active surveillance
(AS).
II. Determine the initial comparative effectiveness of two intervention programs (IF and
CER) on weight loss and PCa progression outcomes.
SECONDARY OBJECTIVE:
I. Compare the effects of the interventions on biomarkers underlying obesity and PCa to
provide mechanistic insights and potential surrogate biomarkers for PCa prognosis.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo the CER intervention consisting of remote lessons containing
information and behavioral strategies about weight loss, session with study
interventionist to review lessons, and self-monitoring of body weight, physical activity
and dietary intake. Patients also undergo collection of blood samples throughout the
trial.
ARM II: 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 fasting. Patients will undergo fasting 2 days
per week and eat according to the National Cancer Institute (NCI) guidelines the
remaining 5 days. Patients also undergo collection of blood samples throughout the trial.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Yeary
Phone:
716-845-1300
Email:
Karen.Yeary@RoswellPark.org
Investigator:
Last name:
Karen Yeary
Email:
Principal Investigator
Start date:
April 24, 2024
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05764330
