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

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ClinicalTrials.gov Identifier: NCT03880422
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE March 1, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE January 3, 2019
Estimated Primary Completion Date January 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Changes in body composition [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • Changes in muscle strength [ Time Frame: 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).
  • Changes in functional capacity muscle strength [ Time Frame: Baseline up to 6 months ]
    Improvement of muscle strenght
  • Change in body composition [ Time Frame: Baseline up to 6 months ]
    All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition
  • myokines concentration [ Time Frame: Baseline up to 6 months ]
    Will be assessed by serum biomarker levels.
  • cytokines concentration [ Time Frame: Baseline up to 6 months ]
    Will be assessed by serum biomarker levels.
  • Health related quality of life Short Form [ Time Frame: 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
  • Changes in dietary intake [ Time Frame: Baseline up to 6 months ]
    Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.
  • Changes in physical activity [ Time Frame: 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.
  • Change in fatigue [ Time Frame: Baseline up to 6 months ]
    Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.
  • Change in Respiratory Muscle Strength [ Time Frame: Baseline up to 6 months ]
    Mouth pressure device
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Changes in muscle strength [ Time Frame: 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).
  • Changes in functional capacity muscle strength [ Time Frame: Baseline up to 6 months ]
    Improvement of muscle strenght
  • Change in body composition [ Time Frame: Baseline up to 6 months ]
    All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition
  • myokines concentration [ Time Frame: Baseline up to 6 months ]
    Will be assessed by serum biomarker levels.
  • cytokines concentration [ Time Frame: Baseline up to 6 months ]
    Will be assessed by serum biomarker levels.
  • Health related quality of life Short Form [ Time Frame: 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
  • Changes in dietary intake [ Time Frame: Baseline up to 6 months ]
    Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.
  • Changes in physical activity [ Time Frame: 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.
  • Change in fatigue [ Time Frame: Baseline up to 6 months ]
    Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.
Current Other Pre-specified Outcome Measures
 (submitted: March 15, 2019)
  • Serum prostate specific antigen (PSA) and androgen levels [ Time Frame: Up to 6 months ]
    Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels.
  • Adherence to nutrition and exercise advice [ Time Frame: Up to 6 months ]
    Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors
Official Title  ICMJE Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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 Name: Quality of Life Assessment
  • Other: Survey Administration
    Ancillary studies
Study Arms  ICMJE 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.
Interventions:
  • Dietary Supplement: Dietary Intervention
  • Other: Educational Intervention
  • Behavioral: Exercise Intervention
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 3, 2022
Estimated Primary Completion Date January 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880422
Other Study ID Numbers  ICMJE I 72118
NCI-2019-00341 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 72118 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Gurkamal S Chatta Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP