Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 22, 2018
Open Peer Review Period: Oct 24, 2018 - Oct 31, 2018
Date Accepted: Jan 7, 2019
(closed for review but you can still tweet)
Comprehensive lifestyle improvement program for prostate cancer (CLIPP): Protocol for a feasibility and exploratory efficacy study in men on androgen deprivation therapy
ABSTRACT
Background:
Androgen deprivation therapy (ADT) for prostate cancer (PCa) is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially increases mortality. Several large clinical trials have demonstrated improvements in cardio-metabolic risk with comprehensive multi-modality lifestyle modification. However, there is paucity of data for such interventions in men on ADT for PCa and existing studies have used non-standardized interventions or lacked data on metabolic risk factors.
Objective:
Aim of the Comprehensive Lifestyle Improvement Project for Prostate Cancer (CLIPP), is designed to address these gaps by using an intervention modeled after The Diabetes Prevention Program (DPP), a standardized multi-component intervention with demonstrated effectiveness in reducing cardio-metabolic risk factors that has been successfully adapted for multiple disease types including breast cancer.
Methods:
A single-arm unblinded clinical trial will be conducted to determine the feasibility of conducting a 24-week comprehensive lifestyle modification intervention (CLMI) that targets weight loss and increased physical activity modeled on the DPP in 30 men on ADT for PCa. Secondary aims are to determine the effect of CLMI on cardio-metabolic markers and QoL. The tertiary aim is to determine the effect of CLMI on markers of inflammation and angiogenesis, important mechanisms for PCa progression. Participants will be recruited from the University of Arizona Cancer Center and the surrounding community. The intervention will be delivered weekly in-person and over the telephone for 16 weeks. For weeks 16 through 24, participants receive weekly phone calls from the study health coach to motivate them to continue their CLMI. Questionnaire and biological data are collected at baseline, 12 and 24 weeks. Body composition using Dual-energy x-ray absorptiometry (DXA) scans will be performed at baseline and end of study.
Results:
Based on a sample size of 30, the two-sided 95% confidence interval will not be wider than 0.373 standard deviations for the adherence rate and will not be wider than 0.374 for the retention rate. In addition, the study will have a power of 80% to detect a change of 0.47 standard deviations from baseline for each of the markers investigated in the secondary and tertiary aims assuming a within-subject correlation of 0.20 at a significance level of 5%. Recruitment has recently started and is expected to be completed in 6 months.
Conclusions:
The CLIPP study determines the feasibility of conducting a DPP style CLMI in men with ADT for PCa and its effects on cardio-metabolic adverse effects, QoL as well as markers of inflammation and angiogenesis. Results will inform the development of future clinical trials in this population. Clinical Trial: Clinicaltrials.gov, pending
Citation
Per the author's request the PDF is not available.
Copyright
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