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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 : September 23, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Dietary Intervention Other: Educational Intervention Behavioral: Exercise Intervention Other: Quality-of-Life Assessment Other: Survey Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : January 3, 2019
Estimated Primary Completion Date : January 3, 2021
Estimated Study Completion Date : January 3, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/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 Name: Quality of Life Assessment

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Changes in functional capacity muscle strength [ Time Frame: Baseline up to 6 months ]
    Improvement of muscle strenght

  3. 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

  4. myokines concentration [ Time Frame: Baseline up to 6 months ]
    Will be assessed by serum biomarker levels.

  5. cytokines concentration [ Time Frame: Baseline up to 6 months ]
    Will be assessed by serum biomarker levels.

  6. 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

  7. Changes in dietary intake [ Time Frame: Baseline up to 6 months ]
    Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.

  8. 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.

  9. Change in fatigue [ Time Frame: Baseline up to 6 months ]
    Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.

  10. Change in Respiratory Muscle Strength [ Time Frame: Baseline up to 6 months ]
    Mouth pressure device


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880422


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Gurkamal S. Chatta    716-845-3117    Gurkamal.Chatta@roswellpark.org   
Principal Investigator: Gurkamal S. Chatta         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gurkamal S Chatta Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03880422     History of Changes
Other Study ID Numbers: 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 )
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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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:
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Genital Diseases, Male
Prostatic Diseases
Prostatic Neoplasms
Adenocarcinoma
Overweight
Frailty
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Body Weight
Signs and Symptoms
Pathologic Processes
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs