CancerNCT02501460
Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors
A study testing Educational handouts, Resistance training and Supplementation in people with Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Cancer
- What is being tested?
- Educational handouts, Resistance training and Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2015to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- Currently pregnant (assessed by serum pregnancy test).
- Contraindications to resistance training or protein supplementation (e.g. renal) verified by a physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the detailed description
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
- Cancer
- Being tested
- Educational handouts, Resistance training, Supplementation, Placebo
- Keywords
- Adult cancer survivors, Exercise, Dietary supplementation
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational handoutsOther
Also called guidelines
Both groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment.
Resistance trainingOther
Also called exercise
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.
SupplementationDietary supplement
Also called protein 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supplement Group | Active comparator | 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. Receives: Other: Educational handouts; Other: Resistance training; Dietary Supplement: Supplementation |
| Placebo Group | Placebo comparator | 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. Receives: Other: Educational handouts; Other: Resistance training; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean muscle mass by arm
Dual x-ray absorptiometry (DEXA) will be used to determine lean muscle mass. Fat free mass will be measured in the total body scanning mode.
Measured: Baseline and at 24 weeks
Change in handgrip by arm
Handgrip strength will be evaluated with a hand held dynamometer.
Measured: Baseline and at 24 weeks
Change in knee extension by arm
Knee extension strength will be evaluated with the Biodex System IV dynamometer.
Measured: Baseline and at 24 weeks
Change in ankle dorsiflexion by arm
Ankle dorsiflexion strength will be evaluated with the Biodex System IV dynamometer.
Measured: Baseline and at 24 weeks
Change in walking speed by arm
Usual walking speed will be evaluated by having participants complete a timed 10 meter walk test.
Measured: Baseline and at 24 weeks
Change in endurance by arm
Endurance will be evaluated by having participants complete the six minute walk test in a level of corridor as outlined by the American Thoracic Society.
Measured: Baseline and at 24 weeks
Change in activity level by arm
Participants will complete the physical activity monitor (PAM) component of the most recent release of the National Health and Nutrition Examination Survey to measure activity levels. The PAM collects information on intensity and duration of common activities like walking and jogging for seven consecutive days. Participants will receive an accelerometer with written instructions, programmed to begin recording 12:01 a.m. on the day after the baseline assessment (the week before they begin training) and the day after their final training appointment.
Measured: Baseline and at 24 weeks
Change in blood pressure by arm
Blood pressure will be evaluated with a sphygmomanometer.
Measured: Baseline and at 24 weeks
Change in high density lipoprotein by arm
High density lipoprotein will be evaluated from fasting blood samples as part of a standard lipid panel.
Measured: Baseline and at 24 weeks
Change in triglycerides by arm
Triglycerides will be evaluated from fasting blood samples as part of a standard lipid panel.
Measured: Baseline and at 24 weeks
Change in abdominal obesity by arm
Abdominal obesity will be evaluated by measuring waist circumference with a Gulick tape measure to the nearest mm.
Measured: Baseline and at 24 weeks
Change in fasting glucose by arm
Glucose level will be measured from fasting blood samples.
Measured: Baseline and at 24 weeks
Change in fasting insulin by arm
Insulin level will be measure from fasting blood samples.
Measured: Baseline and at 24 weeks
Change in C-reactive protein by arm
Highly sensitive C-reactive protein will be measured from fasting blood samples.
Measured: Baseline and at 24 weeks
Change in self-reported exhaustion by arm
Measured using the vitality subscale of the Medical Outcomes Survey Short Form-36 (SF-36), version 2.
Measured: Baseline and at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study start17 Aug 2015
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ATC Fitness, American Institute for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Kirsten K. Ness, PT, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501460
- Sponsor's protocol ID
- REPS
- Other IDs
- AICR FDN YR 1, NCI-2015-01152
- Status last verified
- Jul 2018
- First submitted
- 15 Jul 2015
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT02501460
- Acronym / sponsor ID
- REPS
- Conditions
- Cancer
- Keywords
- Adult cancer survivors, Exercise, Dietary supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- ATC Fitness, American Institute for Cancer Research
- Study start
- 17 Aug 2015 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Active comparator | Other: Educational handouts, Other: Resistance training, Dietary Supplement: SupplementationParticipants 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. |
| Placebo Group | Placebo comparator | Other: Educational handouts, Other: Resistance training, Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Currently pregnant (assessed by serum pregnancy test).
- Contraindications to resistance training or protein supplementation (e.g. renal) verified by a physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational handoutsAlso: guidelinesBoth groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment. | Other | Placebo Group, Supplement Group |
| Resistance trainingAlso: exerciseIndividuals 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. | Other | Placebo Group, Supplement Group |
| SupplementationAlso: protein dietary supplementA 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. | Dietary supplement | Supplement Group |
| PlaceboA 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. | Other | Placebo Group |
Primary outcome
Change in lean muscle mass by arm
Time frame: Baseline and at 24 weeks
Dual x-ray absorptiometry (DEXA) will be used to determine lean muscle mass. Fat free mass will be measured in the total body scanning mode.
Change in handgrip by arm
Time frame: Baseline and at 24 weeks
Handgrip strength will be evaluated with a hand held dynamometer.
Change in knee extension by arm
Time frame: Baseline and at 24 weeks
Knee extension strength will be evaluated with the Biodex System IV dynamometer.
Change in ankle dorsiflexion by arm
Time frame: Baseline and at 24 weeks
Ankle dorsiflexion strength will be evaluated with the Biodex System IV dynamometer.
Change in walking speed by arm
Time frame: Baseline and at 24 weeks
Usual walking speed will be evaluated by having participants complete a timed 10 meter walk test.
Change in endurance by arm
Time frame: Baseline and at 24 weeks
Endurance will be evaluated by having participants complete the six minute walk test in a level of corridor as outlined by the American Thoracic Society.
Change in activity level by arm
Time frame: Baseline and at 24 weeks
Participants will complete the physical activity monitor (PAM) component of the most recent release of the National Health and Nutrition Examination Survey to measure activity levels. The PAM collects information on intensity and duration of common activities like walking and jogging for seven consecutive days. Participants will receive an accelerometer with written instructions, programmed to begin recording 12:01 a.m. on the day after the baseline assessment (the week before they begin training) and the day after their final training appointment.
Change in blood pressure by arm
Time frame: Baseline and at 24 weeks
Blood pressure will be evaluated with a sphygmomanometer.
Change in high density lipoprotein by arm
Time frame: Baseline and at 24 weeks
High density lipoprotein will be evaluated from fasting blood samples as part of a standard lipid panel.
Change in triglycerides by arm
Time frame: Baseline and at 24 weeks
Triglycerides will be evaluated from fasting blood samples as part of a standard lipid panel.
Change in abdominal obesity by arm
Time frame: Baseline and at 24 weeks
Abdominal obesity will be evaluated by measuring waist circumference with a Gulick tape measure to the nearest mm.
Change in fasting glucose by arm
Time frame: Baseline and at 24 weeks
Glucose level will be measured from fasting blood samples.
Change in fasting insulin by arm
Time frame: Baseline and at 24 weeks
Insulin level will be measure from fasting blood samples.
Change in C-reactive protein by arm
Time frame: Baseline and at 24 weeks
Highly sensitive C-reactive protein will be measured from fasting blood samples.
Change in self-reported exhaustion by arm
Time frame: Baseline and at 24 weeks
Measured using the vitality subscale of the Medical Outcomes Survey Short Form-36 (SF-36), version 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten K. Ness, PT, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational handouts, Resistance training and Supplementation in people with Cancer, run by St. Jude Children's Research Hospital 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 2 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: finished, as of the sponsor's last update on 17 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean muscle mass by arm (time frame: Baseline and at 24 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.