Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-17

Study Completion Date

2018-01-30

Brief Summary

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This study is being conducted because low lean muscle mass is prevalent among childhood cancer survivors. Lean muscle is the non-fatty muscle tissue that makes up part of the body's lean body mass. Low lean muscle mass is associated with loss of overall body strength, declining mobility and eventually, loss of independence. Among childhood cancer survivors, low lean muscle mass may contribute to reduced physical functioning and a sense of fatigue with exertion, limiting ability to participate in adequate physical activity. Loss of strength and a sense of fatigue with repeated movement make it difficult to participate in daily activities.

Although there have not been exercise intervention studies among childhood cancer survivors specifically designed to evaluate the effects of resistance training on muscle mass, studies among individuals with chronic disease, including survivors of adult onset cancers, indicate that resistance exercise improves muscle mass, muscle strength, mobility, vitality and physical activity levels. Resistance training (weight lifting) is a form of physical activity that is designed to improve muscular fitness by exercising a muscle or a muscle group against external resistance.

The purpose of the study is to evaluate the effects of resistance training combined with either a protein supplement or a sports drink on changes in lean muscle mass in young adults who were treated for childhood cancer. The sports drink, for this study, is considered a placebo.

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Detailed Description

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This double-blind placebo controlled study will randomize adult survivors of childhood cancer who are 18 to 44 years of age, greater than ten years post first cancer diagnosis, and with low lean muscle mass to two groups: Resistance Training + Supplement (RT+S) or Resistance Training + Placebo (RT+P). Randomization will be stratified by sex and age (18-29 and 30-44 years) in a block size of 4. Three weekly resistance training sessions will occur over a 24 week period. The participants, investigator, trainer and individuals involved in testing will be blind to group assignment.

Participants will receive information about physical activity and its health benefits. They will be randomly assigned to one of two groups to receive individually tailored resistance training three times per week for 24 weeks. One group will receive a protein supplement, while the other group will receive a sports drink (placebo).

To assess outcomes, participants will have the following research tests:

* Blood will be drawn to assess heart health.
* Questionnaires will be completed to assess physical activity and health as well as food intake.
* Blood pressure measurement.
* Electrocardiogram to assess heart health.
* Height, weight, waist and hip measurements.
* Lean muscle mass will be measured by dual x-ray absorptiometry (DEXA scan).
* Muscle strength will be measured by handgrip, knee extension, and ankle dorsiflexion.
* Walking speed to determine usual walking speed.
* Six-minute walk test to determine endurance.
* Physical activity will be monitored by having the participant complete a survey and wear a small recording device (accelerometer) for seven days.

Study Objectives:

* To evaluate the effects of 24-week supervised RT+S compared to RT+P on changes in lean muscle mass, muscle strength, walking speed, self-reported exhaustion and physical activity levels among childhood cancer survivors.
* To evaluate the effects of 24-week supervised RT+S compared to RT+P on changes in blood pressure, high density lipoprotein, triglycerides, abdominal obesity, fasting glucose, fasting insulin, and C-reactive protein among childhood cancer survivors.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Supplement Group

Participants will receive educational handouts and complete research testing to evaluate their physical condition prior to beginning the resistance training and dietary supplementation. Adherence will be assured as described below.

Group Type ACTIVE_COMPARATOR

Educational handouts

Intervention Type OTHER

Both groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment.

Resistance training

Intervention Type OTHER

Individuals in both groups will participate in an individually tailored progressive resistance training program 3 times/week for 24 weeks. During weeks 1-4 participants will be supervised twice a week tapering to once a week in weeks 5-12, every other week in weeks 13-20 and then once a month in weeks 21-24 by an American College of Sports Medicine (ACSM) Certified Exercise Specialist (trainer).

Adherence: To assure fidelity and safety of the resistance training component of the intervention, participants will initially be supervised more frequently They will complete an exercise log for each of their sessions. As the supervision level for exercise is tapered, participants may receive reminders to exercise and take their supplement/placebo via text, phone, or e-mail as needed.

Supplementation

Intervention Type DIETARY_SUPPLEMENT

A medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.

Placebo Group

Participants will receive educational handouts and complete research testing to evaluate their physical condition prior to beginning the resistance training and placebo. Adherence will be assured as described below.

Group Type PLACEBO_COMPARATOR

Educational handouts

Intervention Type OTHER

Both groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment.

Resistance training

Intervention Type OTHER

Individuals in both groups will participate in an individually tailored progressive resistance training program 3 times/week for 24 weeks. During weeks 1-4 participants will be supervised twice a week tapering to once a week in weeks 5-12, every other week in weeks 13-20 and then once a month in weeks 21-24 by an American College of Sports Medicine (ACSM) Certified Exercise Specialist (trainer).

Adherence: To assure fidelity and safety of the resistance training component of the intervention, participants will initially be supervised more frequently They will complete an exercise log for each of their sessions. As the supervision level for exercise is tapered, participants may receive reminders to exercise and take their supplement/placebo via text, phone, or e-mail as needed.

Placebo

Intervention Type OTHER

A placebo that appears to be identical to the medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.

Interventions

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Educational handouts

Both groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment.

Intervention Type OTHER

Resistance training

Individuals in both groups will participate in an individually tailored progressive resistance training program 3 times/week for 24 weeks. During weeks 1-4 participants will be supervised twice a week tapering to once a week in weeks 5-12, every other week in weeks 13-20 and then once a month in weeks 21-24 by an American College of Sports Medicine (ACSM) Certified Exercise Specialist (trainer).

Adherence: To assure fidelity and safety of the resistance training component of the intervention, participants will initially be supervised more frequently They will complete an exercise log for each of their sessions. As the supervision level for exercise is tapered, participants may receive reminders to exercise and take their supplement/placebo via text, phone, or e-mail as needed.

Intervention Type OTHER

Supplementation

A medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.

Intervention Type DIETARY_SUPPLEMENT

Placebo

A placebo that appears to be identical to the medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.

Intervention Type OTHER

Other Intervention Names

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guidelines exercise protein dietary supplement

Eligibility Criteria

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Inclusion Criteria

* Participants must be enrolled on the SJLIFE protocol at St. Jude Children's Research Hospital.
* 18.0-44.99 years of age
* \>10 years post first cancer diagnosis.
* English speaking.
* Live within a 45-minute drive of a greater Memphis area ATC Fitness Center
* Low lean mass defined as either:

* Age- and sex-specific relative lean muscle mass standard deviation score ≤ -1.0.

OR

* Body fat content greater than or equal to 25% in males or greater than or equal to 35% in females.

Exclusion Criteria

* Currently pregnant (assessed by serum pregnancy test).
* Contraindications to resistance training or protein supplementation (e.g. renal) verified by a physician.

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No