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

Primary Purpose

Cancer Survivor, Obesity, Overweight

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Educational Intervention
Exercise Intervention
Quality-of-Life Assessment
Survey Administration
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (diet, exercise, education)

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in body composition
Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.

Secondary Outcome Measures

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).
Changes in functional capacity muscle strength
Improvement of muscle strenght
Change in body composition
All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition
myokines concentration
Will be assessed by serum biomarker levels.
cytokines concentration
Will be assessed by serum biomarker levels.
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
Changes in dietary intake
Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.
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.
Change in fatigue
Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.
Change in Respiratory Muscle Strength
Mouth pressure device

Full Information

First Posted
March 1, 2019
Last Updated
April 24, 2023
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03880422
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
April 4, 2024 (Anticipated)
Study Completion Date
April 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (diet, exercise, education)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Receive diet plan
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Attend educational meeting
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Complete exercise program
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Changes in body composition
Description
Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.
Time Frame
Baseline up to 6 months
Secondary Outcome Measure Information:
Title
Changes in muscle strength
Description
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).
Time Frame
Baseline up to 6 months
Title
Changes in functional capacity muscle strength
Description
Improvement of muscle strenght
Time Frame
Baseline up to 6 months
Title
Change in body composition
Description
All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition
Time Frame
Baseline up to 6 months
Title
myokines concentration
Description
Will be assessed by serum biomarker levels.
Time Frame
Baseline up to 6 months
Title
cytokines concentration
Description
Will be assessed by serum biomarker levels.
Time Frame
Baseline up to 6 months
Title
Health related quality of life Short Form
Description
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
Time Frame
Up to 6 months
Title
Changes in dietary intake
Description
Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.
Time Frame
Baseline up to 6 months
Title
Changes in physical activity
Description
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.
Time Frame
Baseline up to 6 months
Title
Change in fatigue
Description
Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.
Time Frame
Baseline up to 6 months
Title
Change in Respiratory Muscle Strength
Description
Mouth pressure device
Time Frame
Baseline up to 6 months
Other Pre-specified Outcome Measures:
Title
Serum prostate specific antigen (PSA) and androgen levels
Description
Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels.
Time Frame
Up to 6 months
Title
Adherence to nutrition and exercise advice
Description
Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics.
Time Frame
Up to 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurkamal S Chatta
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gurkamal S. Chatta
Phone
716-845-3117
Email
Gurkamal.Chatta@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Gurkamal S. Chatta

12. IPD Sharing Statement

Learn more about this trial

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

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