NCT04987359
Active, not recruiting
Not Applicable
A Randomized Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
ConditionsNeoplasm Malignant
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasm Malignant
- Sponsor
- Pennington Biomedical Research Center
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Change in cardiorespiratory fitness capacity (co-primary)
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.
Investigators
Justin Brown
Assistant Professor
Pennington Biomedical Research Center
Eligibility Criteria
Inclusion Criteria
- •Ability to provide informed consent before any trial-related activities
- •History of any malignancy
- •Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate)
- •No evidence of residual or recurrent cancer under active treatment
- •Age ≥18 years
- •Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions
- •Willing to be randomized
- •Allow the collection and storage of biospecimens and data for future use
Exclusion Criteria
- •Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks
- •Significant purposeful weight loss (\>11 kg) within the past 12 weeks
- •Current use of medications or devices for the purpose of weight loss
- •Metabolic or bariatric surgery within the last year
- •Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program
- •Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks
- •Psychiatric disorders or conditions that would preclude participation in the study intervention
- •Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study
Outcomes
Primary Outcomes
Change in cardiorespiratory fitness capacity (co-primary)
Time Frame: Baseline, Week 10
Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test.
Change in body weight (co-primary)
Time Frame: Baseline, Week 10
Bodyweight assessed using a digital scale in a fasting state with an empty bladder, without shoes, and only wearing light clothing.
Secondary Outcomes
- Change in systolic blood pressure(Baseline, Week 10)
- Change in fat Mass(Baseline, Week 10)
- Change in waist Circumference(Baseline, Week 10)
- Change in diastolic blood pressure(Baseline, Week 10)
- Change in physical and mental quality-of-life(Baseline, Week 10)
- Change in medication use(Baseline, Week 10)
Study Sites (1)
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