Prostate Cancer
Conditions
Keywords
Low Carbohydrate, Ketogenic, Androgen Deprivation Therapy
Brief summary
This study is an investigator initiated clinical study. A prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 36 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.
Detailed description
INTRODUCTION: Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa). ADT for 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 affects mortality. There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors. CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP) with an emphasis on low carbohydrate and a Keto Diet, a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer. INTERVENTION: * 24 Weeks * Health Coaching Weekly * Serum & Urine Baseline, Week 12 and Week 24 * Anthropometric Measures * Questionnaires * BMI Measurements
Interventions
BEHAVIORALCLIPP2
Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.
Sponsors
M.D. Anderson Cancer Center
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pre and Post Study Model
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with prostate cancer Stage I, II or III * On androgen deprivation therapy with last 5 years * Willing to participate in a lifestyle modification program * Willing to modify diet and eating practices * Willing to participate in blood collection, urine collection and measurements * Minimum of 30 days since participating in another study/trial * English speaking * 40 to 80 years of age * BMI \>25%
Exclusion criteria
* Currently participating in another study or trial * Currently in hospice * Inability to walk two city blocks * Inability to comprehend informed consent or procedural requirements * Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake * Subjects already following an intensive lifestyle modification plan * BMI \<25%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Intervention | 6 Months | 75% attendance rate throughout 24 intervention visits |
| Retention of Participants | 6 Months | 75% retention rate |
| Reach Recruiting Target | 6 Months | Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 6 Months | Unit of Measure % |
| CBC | 6 Months | Unit of Measure Mg/dL |
| Global Quality of Life Questionnaire | 6 Months | PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5 1=Poor 5=Excellent |
| Specific Quality of Life Questionnaire | 6 Months | Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scale of Measurement 0 to 4. 0=No Problem 4=Big Problem |
| CMP | 6 Months | Unit of Measure Mg/dL |
| Fasting Glucose | 6 Months | Unit of Measure Mg/dL |
| Lipid Panel | 6 Months | Unit of Measure Mg/dl |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Pathways Associated with Prostate Cancer | 6 Months | Inflammation markers measured will include Interleukin-6, Interleukin 1-beta, Interleukin-8, stromal cell derived factor 1-alpha & basic fibroblast growth factor. |
| Angiogenic Pathways Associated with Prostate Cancer | 6 Months | Determine the effect of comprehensive lifestyle modification intervention on angiogenesis, markers, important mechanisms for prostate cancer progression using blood, serum and urine. Angiogenesis markers will include vascular endothelial growth factor & plasma placental growth factor using Enzyme Linked Immunosorbent Assay (ELISA) |
Countries
United States
Contacts
Primary ContactTracey Smith
Backup ContactAmit Algotar, MD, PhD, MPH
Outcome results
None listed