Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Obesity Clinical Trial

Official title:

Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03880422
• Other study ID #: I 72118
• Secondary ID: NCI-2019-00341I
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: May 2, 2029

Study information

• Verified date: May 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2, 2029
• Est. primary completion date: May 2, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

• Body mass index (BMI) > 25.0 (overweight and obese)

• 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)

• Patients on ADT with concurrent chemotherapy, immunotherapy and/or radiotherapy. Palliative radiation okay.

• 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

Related Conditions & MeSH terms

• Cancer Survivor
• Frailty
• Obesity
• Overweight
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• 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

Intervention

Dietary Supplement:
• Dietary Intervention
Receive diet plan

Other:
• Educational Intervention
Attend educational meeting

Behavioral:
• Exercise Intervention
Complete exercise program

Other:
• Quality-of-Life Assessment
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum prostate specific antigen (PSA) and androgen levels	Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels.	Up to 6 months
Other	Adherence to nutrition and exercise advice	Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics.	Up to 6 months
Primary	Changes in body composition	Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.	Baseline up to 6 months
Secondary	Changes in muscle strength	Will be assessed by chest press, leg press, grip strength,6-minute walk test, timed-up-and-go, agility, Berg balance scale, short physical performance battery (SPPB).	Baseline up to 6 months
Secondary	Changes in functional capacity muscle strength	Improvement of muscle strenght	Baseline up to 6 months
Secondary	Change in body composition	All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition	Baseline up to 6 months
Secondary	myokines concentration	Will be assessed by serum biomarker levels.	Baseline up to 6 months
Secondary	cytokines concentration	Will be assessed by serum biomarker levels.	Baseline up to 6 months
Secondary	Health related quality of life Short Form	Will be used to assess quality of life . The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, Lower scores = more disability, higher scores = less disability	Up to 6 months
Secondary	Changes in dietary intake	Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.	Baseline up to 6 months
Secondary	Changes in physical activity	Will be assessed by Godin Leisure Time survey and Fitbit activity report. Will be summarized by time point using the observed sample size, mean, and standard deviation. Will be evaluated using a two-sided permutation paired t-test. Additionally, the mean change in each outcome will be estimated using a 95% confidence interval. As exploratory analyses, the association between the change in each outcome and demographic/clinical factors may be evaluated using general linear models. The change in outcome will be modeled as a function of baseline levels and each demographic/clinical factor in a one-at-a-time manner.	Baseline up to 6 months
Secondary	Change in fatigue	Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.	Baseline up to 6 months
Secondary	Change in Respiratory Muscle Strength	Mouth pressure device	Baseline up to 6 months