Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors
Condition: Cancer
Study type: Interventional

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. 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.
    

Intervention name(s): Educational handouts; Resistance training; Supplementation; Placebo
Intervention type(s): Other; Other; Dietary Supplement; Other
Intervention description(s): Both groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment.; 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.; 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.; 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.
Other intervention name(s): guidelines; exercise; protein dietary supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Adult cancer survivors; Exercise; Dietary supplementation