Clinical trial NCT03880422: Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors
Official title: Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Survivor
Obesity
Overweight
Prostate Adenocarcinoma
Stage A Prostate Cancer
Stage B Prostate Cancer
Stage C Prostate Cancer
Stage D Prostate Cancer
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage IIC Prostate Cancer
Stage III Prostate Cancer
Stage IIIA Prostate Cancer
Stage IIIB Prostate Cancer
Stage IIIC Prostate Cancer
Stage IV Prostate Cancer
Stage IVA Prostate Cancer
Stage IVB Prostate Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.

Detailed description: PRIMARY OBJECTIVES:

I. Assess the effect of individualized nutrition and exercise counseling interventions on myokine expression and body composition in prostate cancer (PrCa) patients being treated with androgen deprivation therapy (ADT).

SECONDARY OBJECTIVES:

I. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions.

II. Determine any changes in myokines, circulating inflammatory and frailty-associated cytokines resulting from the nutrition and exercise counseling interventions.

III. Determine the effect of the study interventions on dietary intake, physical activity, fatigue, and quality of life.

EXPLORATORY OBJECTIVES:

I. Correlate changes in secondary objectives with prostate specific antigen (PSA) and testosterone levels.

II. Evaluate adherence to nutrition and exercise advice. III. Evaluate assessment tools and recruiting strategies.

OUTLINE:

Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.

Eligibility criteria: Inclusion Criteria:

* Biopsy-confirmed prostate adenocarcinoma of any stage/grade
* Prescribed or already receiving continuous ADT for \< 5 years
* Hemoglobin \> 11 g/dL
* Creatinine \< 1.5 x upper limit of normal (ULN), AST or ALT \<2 x ULN within 6 months prior to enrollment
* Liver function tests \< 2 x ULN
* Able to walk unassisted at least 100 meters (200 steps) or ECOG \<= 1
* No contraindications to any aspect of participation, including aerobic exercise
* Participant must be able to read, write, and understand the English language and be able to provide written consent
* 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:

* Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
* Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion)
* Overall medical frailty (clinician discretion)
* Any condition contraindicating additional blood collection beyond standard of care
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Primary outcomes:
measure: Changes in body composition
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Changes in muscle strength
timeFrame: Baseline up to 6 months
measure: Changes in functional capacity muscle strength
timeFrame: Baseline up to 6 months
measure: Change in body composition
timeFrame: Baseline up to 6 months
measure: myokines concentration
timeFrame: Baseline up to 6 months
measure: cytokines concentration
timeFrame: Baseline up to 6 months
measure: Health related quality of life Short Form
timeFrame: Up to 6 months
measure: Changes in dietary intake
timeFrame: Baseline up to 6 months
measure: Changes in physical activity
timeFrame: Baseline up to 6 months
measure: Change in fatigue
timeFrame: Baseline up to 6 months
measure: Change in Respiratory Muscle Strength
timeFrame: Baseline up to 6 months
Other outcomes:
measure: Serum prostate specific antigen (PSA) and androgen levels
timeFrame: Up to 6 months
measure: Adherence to nutrition and exercise advice
timeFrame: Up to 6 months
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Gurkamal S Chatta
role: PRINCIPAL_INVESTIGATOR
References: