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Cancer SurvivorNCT03880422

Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer

A study testing Dietary Intervention, Educational Intervention and Exercise Intervention in people with Cancer Survivor and Obesity, run by Roswell Park Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cancer Survivor, Obesity, Overweight
What is being tested?
Dietary Intervention, Educational Intervention and Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
2 May 2019to 2 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Able to walk unassisted at least 100 meters (200 steps) or ECOG <= 1
Show all 9Show fewer
  • 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

Who cannot join

  • 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)
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ellis Levine, MD contact

716-845-3159

Ellis.Levine@Roswellpark.org

United States1 site, 1 recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Ellis Levine, MD, 716-845-3159, Ellis.Levine@roswellpark.org

    Ellis Levine, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

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:

  1. 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.

Being tested
Dietary Intervention, Educational Intervention, Exercise Intervention, Quality-of-Life Assessment, Survey Administration
Medical subject headings
Obesity, Overweight, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary InterventionDietary supplement

    Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions

    Receive diet plan

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Attend educational meeting

  • Exercise InterventionBehavioural

    Complete exercise program

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT03880422
Study groupRoleWhat they receive
Supportive care (diet, exercise, education)ExperimentalPatients 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.
Receives: Dietary Supplement: Dietary Intervention; Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in body composition

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

    Measured: Baseline up to 6 months

Secondary outcomes (10)

  1. 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).

    Measured: Baseline up to 6 months

  2. Changes in functional capacity muscle strength

    Improvement of muscle strenght

    Measured: Baseline up to 6 months

  3. Change in body composition

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

    Measured: Baseline up to 6 months

  4. myokines concentration

    Will be assessed by serum biomarker levels.

    Measured: Baseline up to 6 months

  5. cytokines concentration

    Will be assessed by serum biomarker levels.

    Measured: Baseline up to 6 months

  6. 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

    Measured: Up to 6 months

  7. Changes in dietary intake

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

    Measured: Baseline up to 6 months

  8. 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.

    Measured: Baseline up to 6 months

  9. Change in fatigue

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

    Measured: Baseline up to 6 months

  10. Change in Respiratory Muscle Strength

    Mouth pressure device

    Measured: Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start2 May 2019
  3. Primary completion2 May 2029 (estimated)
  4. Study completion2 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03880422
Sponsor's protocol ID
I 72118
Other IDs
NCI-2019-00341, I 72118
Status last verified
May 2026
First submitted
1 Mar 2019
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Intervention, Educational Intervention and Exercise Intervention in people with Cancer Survivor and Obesity, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ellis Levine, MD (716-845-3159, Ellis.Levine@Roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in body composition (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03880422.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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