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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03880422
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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:
  1. 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:
  1. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions.

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

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

EXPLORATORY OBJECTIVES:
  1. Correlate changes in secondary objectives with prostate specific antigen (PSA) and testosterone levels.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer
Actual Study Start Date :
Jan 3, 2019
Anticipated Primary Completion Date :
Jan 3, 2023
Anticipated Study Completion Date :
Jan 3, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Supportive care (diet, exercise, education)

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.

Dietary Supplement: Dietary Intervention
Receive diet plan
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
  • Other: Educational Intervention
    Attend educational meeting
    Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
  • Behavioral: Exercise Intervention
    Complete exercise program

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

    Outcome Measures

    Primary Outcome Measures

    1. Changes in body composition [Baseline up to 6 months]

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

    Secondary Outcome Measures

    1. Changes in muscle strength [Baseline up to 6 months]

      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).

    2. Changes in functional capacity muscle strength [Baseline up to 6 months]

      Improvement of muscle strenght

    3. Change in body composition [Baseline up to 6 months]

      All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition

    4. myokines concentration [Baseline up to 6 months]

      Will be assessed by serum biomarker levels.

    5. cytokines concentration [Baseline up to 6 months]

      Will be assessed by serum biomarker levels.

    6. Health related quality of life Short Form [Up to 6 months]

      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

    7. Changes in dietary intake [Baseline up to 6 months]

      Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.

    8. Changes in physical activity [Baseline up to 6 months]

      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.

    9. Change in fatigue [Baseline up to 6 months]

      Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.

    10. Change in Respiratory Muscle Strength [Baseline up to 6 months]

      Mouth pressure device

    Other Outcome Measures

    1. Serum prostate specific antigen (PSA) and androgen levels [Up to 6 months]

      Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels.

    2. Adherence to nutrition and exercise advice [Up to 6 months]

      Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Gurkamal S Chatta, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT03880422
    Other Study ID Numbers:
    • I 72118
    • NCI-2019-00341
    • I 72118
    First Posted:
    Mar 19, 2019
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 23, 2021