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 is associated with adverse cardiometabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction, and stroke. This reduces quality of life and potentially increases mortality. Several large clinical trials have demonstrated improvements in cardiometabolic risk with comprehensive multimodality lifestyle modification. However, there is a lack of data for such interventions in men on ADT for prostate cancer, and existing studies have used non-standardized interventions or lacked data on metabolic risk factors. Objective The Comprehensive Lifestyle Improvement Project for Prostate Cancer (CLIPP) is designed to address these gaps by using an intervention modeled on the Diabetes Prevention Program, a standardized multicomponent intervention with demonstrated effectiveness in reducing cardiometabolic 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 that targets weight loss and increased physical activity modeled on the Diabetes Prevention Program in 30 men on ADT for prostate cancer. Secondary aims are to determine the effect of the intervention on cardiometabolic markers and quality of life. The tertiary aim is to determine the effect of the intervention on markers of inflammation and angiogenesis, important mechanisms for prostate cancer 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 phone for 16 weeks. For Weeks 16-24, participants receive weekly phone calls from the study health coach to motivate them to continue their lifestyle modification. Questionnaire and biological data are collected at baseline, 12 weeks, and 24 weeks. Body composition using dual-energy x-ray absorptiometry 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%. The recruitment period is from October 2018 to April 2019. Conclusions The aim of CLIPP is to determine the feasibility of conducting a Diabetes Prevention Program–style comprehensive lifestyle modification intervention in men with ADT for prostate cancer and its effects on cardiometabolic adverse effects, quality of life, as well as markers of i...

Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2)

“…CLIPP2 builds on lessons learned from our prior study [ 17 ] which shows that, 1) participants prefer an intervention delivered remotely, rather than one in which they need to have in-person contact with the health coach; 2) instead of short reminder calls, participants prefer longer phone calls, providing them the opportunity to ask questions and problem solve if needed; 3) participants found some of the questionnaires confusing; 4) they also found having to log their food intake to be cumbersome and time consuming. In order to address these concerns, the following changes have been made to the CLIPP2 protocol: 1) the intervention will be delivered entirely remotely via telephone, eliminating the need for participants to meet the health coach in-person; this allows for better compliance and flexibility for participants.…”

“…Only those participants who do not drop out from the study will be included in deriving changes from baseline for both secondary and tertiary aims. Our prior studies of lifestyle modification in this population report a study dropout rate of 10% [ 17 ]. We, therefore, conservatively assume a dropout rate of 15%, i.e.…”

“…This includes low carbohydrate diet, aerobic physical activity, sleep optimization, and stress management. CLIPP2 will provide a robust multi-behavioral approach customized for men on ADT for prostate cancer and build on lessons learned from our prior study in this population [ 17 ].…”

Sexual and Psychoemotional Disorders in Male Patients Treated for Prostate Carcinoma

“…However, health status also had an insignificant impact on patients feeling worried, even though patients with a greater quality of life score more rarely declared that they felt worried. Other studies suggest that hot flushes were strongly associated with insomnia and they caused depression particularly in the group of elderly men receiving hormone therapy [17][18][19]. However, Yang et al [20] determined that physical condition of cancer patients was closely related to the fatigue index and it was also the major factor affecting the quality of life of patients.…”

Profiling of metabolic biomarkers in the serum of prostate cancer patients

“…Hormone therapy known as androgen deprivation therapy (ADT) is commonly used to treat advanced prostate cancer however, it is associated with numerous side effects that can influence the quality of life. Metabolic syndrome, sexual dysfunction, osteoporosis, osteoarthritis, gynecomastia, obesity, insulin resistance, diabetes, dyslipidemia, hypertension, cardiovascular disease and depression are well-described complications of androgen deprivation therapy [13][14][15][16].…”