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.

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.

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

Educational handouts

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.

Resistance training

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.

Supplementation

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.

Placebo

Kirsten K. Ness, PT, PhD

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.

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.

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

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.

Handgrip strength will be evaluated with a hand held dynamometer.

Knee extension strength will be evaluated with the Biodex System IV dynamometer.

Ankle dorsiflexion strength will be evaluated with the Biodex System IV dynamometer.

Usual walking speed will be evaluated by having participants complete a timed 10 meter walk test.

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.

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.

Blood pressure will be evaluated with a sphygmomanometer.

High density lipoprotein will be evaluated from fasting blood samples as part of a standard lipid panel.

Triglycerides will be evaluated from fasting blood samples as part of a standard lipid panel.

Abdominal obesity will be evaluated by measuring waist circumference with a Gulick tape measure to the nearest mm.

Glucose level will be measured from fasting blood samples.

Insulin level will be measure from fasting blood samples.

Highly sensitive C-reactive protein will be measured from fasting blood samples.

Measured using the vitality subscale of the Medical Outcomes Survey Short Form-36 (SF-36), version 2.

ATC Fitness

American Institute for Cancer Research

St. Jude Children's Research Hospital

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Other Dietary Supplements

All Drugs and Chemicals

Creatine

They receive physical activity and nutrition recommendations.

They will perform resistance training and placebo in the supplementation.

They will perform the same resistance training and will also receive creatine supplementation

5 g/day supplementation of creatine for the duration of the exercise the 16-week intervention.

The RG and the RCG will receive a supplement of soluble protein powder (20-30 g) daily.

Creatine supplementation

They will do resistance training. Resistance training will be a 16-week supervised workout that will consist of a series of resistance exercises (leg press, knee extension, knee bends, chest press, sit-ups, back extensions, pull-ups, and shoulder press) that involved the largest muscle groups of the body and will be performed three times a week on non-consecutive days.

Arkaitz Castañeda, PhD

Jon Cacicedo, Dr

Background: Creatine supplementation is an effective ergogenic nutrient for athletes, as well as people for people starting a health or fitness program. Resistance training previously been identified as an important method of increasing muscle mass and strength among people, specially in people with cancer to avoid sarcopenia. The potential of creatine supplementation for adaptations produced by strength training in cancer patients are still unknown.

Objective: the primary aim of this study is to evaluate the effectiveness of a 16-week supervised resistance training program intervention with and without creatine supplementation in patients with breast cancer.

Methods: A multicentre, randomized, double-blind, placebo-controlled study designed to evaluate the effects of creatine supplementation in addition to resistance training in breast cancer patients. Patients will be randomly assigned to 3 groups: a control group (CG) and two experimental groups. The first resistance training group (RG) will perform resistance training, while the second resistance-creatine experimental group (RCG) will perform the same resistance training as the RG and will also receive a 5 g/day supplementation of creatine for the duration of the exercise the 16-week intervention. RG participants will follow the same daily dosing protocol, but in their case, with dextrose/maltodextrin. Resistance training will be a 16-week supervised workout that will consist of a series of resistance exercises (leg press, knee extension, knee bends, chest press, sit-ups, back extensions, pull-ups, and shoulder press) that involved the largest muscle groups of the body and will be performed three times a week on non-consecutive days. Both the RG and the RCG will receive a supplement of soluble protein powder (20-30 g) daily.

Discussion: The results of this intervention will help to better understand the potential of non-pharmacological treatment for improving strength and wellbeing values in breast cancer patients with and without creatine supplementation.

Creatine Supplementation and Resistance Training in Patients With Breast Cancer

Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study)

The maximal resistance in the upper and lower body will be measured in terms of the 5-repetition maximum test (5RM) (i.e. the maximum load that can be lifted five times) in chest and leg press exercises, respectively. Also a handgrip dynamometry test will be used to measure grip resistance.

Saliva samples will be taken from the participants using buccal swabs (4N6FLOQSwab, Life Technologies, Carlsbad, CA). The genetic analysis will be performed using Biomark HD system microfluidic analysis technology (Fluidigm, South San Francisco, CA). From that analysis DNA will be extracted using the QIAmp DNA Mini kit (Qiagen, Hilden, Germany) and will be quantified fluorometrically using Qubit (LifeTechnologies).

A 5/10 ml of urine will be collected in a 15 ml sterile plastic universal container tube kept at room temperature no more than 60 minutes, then stored at -20°C. Total RNA will be extracted from 400 μl of urine by using miRNeasy Serum/Plasma Kit (QIAGEN).

Physical function is assessed by the 6 Minute Walk Test (6MWT) in a 20-meter corridor. Is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

A 30-s chair test will be performed performed to measure functional capacity. The number of stands a person can complete in 30 seconds will be recorded.

Body composition (percentages of type of tissue) will be measured using a bioelectrical impedance analysis (Inbody 770, In-Bldg).

Habitual food consumption and nutrient intake will be evaluated using the dietary history questionnaire.

The unidimensional Gastrointestinal Function questionnaire was used to assess gastrointestinal discomfort. This questionnaire consists of 9 items with a frequency scale of 4 response options \[none (0 points), mild (1 point), moderate (2 points) and severe (3 points)\].

The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is used to assess general health-related quality of life status across physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health domains (higher scores indicating a greater quality of life). with scores for each of these scales (or dimensions) ranging from 0 to 100. Higher scores indicate higher quality of life.

Cancer-specific quality of life is evaluated by the core quality of life (QLQ-C-30) questionnaire developed by the European Organization for Research and Treatment of Cancer (EORTC). This questionnaire includes five functional domains (physical, role, cognitive, emotional, and social, with higher scores representing greater function/quality of life) and three symptom scales (fatigue, pain, and nausea, with lower scores indicating greater quality of life/less symptom severity).

The cancer-related fatigue is assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale. For all FACIT scales and symptom indices, the higher the score the better the quality of life.

Hospital de Cruces

Hospital de Basurto

Poznan University of Medical Sciences

Hospital Universitario de Burgos

University of Calabria

University of Deusto

Principal Investigator

Herbal and Botanical

Caseins

Soy Bean

soy (soy protein supplementation 50 grams/day)

milk protein supplementation 50 grams/day

placebo (milk protein supplementation 50 grams/day)

Milk

Moshe Shike, MD

To Test Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue using a Randomized Placebo Controlled Study.

Objectives:

* To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
* To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
* To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.

Patient Population:

Pre and post menopausal women with breast cancer diagnosed by core needle biopsy scheduled to undergo breast cancer resection for an invasive carcinoma.

Objectives:

* To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
* To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
* To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.

Study Design and Intervention Plan:

* Eligible patients will be consented at the time of visit with MSKCC breast surgeon and randomized to receive soy (soy protein supplementation 50 grams/day), or placebo (milk protein supplementation 50 grams/day) over the period until their surgery.
* The diagnostic biopsy (already available at time of appointment with MSKCC surgeon) will be analyzed by immunohistochemistry for proliferation (Ki67) and apoptosis (TUNEL). Additional immunohistochemistry will include HER2, TP53, cyclin D1, p27, BCL2, ER and PR.
* Excision of the breast carcinoma (lumpectomy or mastectomy) will proceed in standard fashion.
* The post-therapy excision specimen will be processed in a standard fashion. Pathologic features, margin status, and tumor size will be assessed by a light microscopic examination of histological sections. In addition to this routine processing, immunohistochemistry assays for proliferation (Ki67), apoptosis (TUNEL), HER2, TP53, cyclin D1, p27, BCL2, ER, and PR will be performed. For correlative biological studies pathologists will select approximately .5 cubic mm representative sections of the neoplastic tissues and normal adjacent breast tissue, which will be snap frozen for gene expression analysis using microarrays.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors	NCT02501460	Cancer	Educational han... Resistance trai... Supplementation Placebo	18 Years - 44 Years	St. Jude Children's Research Hospital
Creatine Supplementation and Resistance Training in Patients With Breast Cancer	NCT05878106	Breast Cancer Supplementation Resistance Trai... Physical Perfor... Quality of Life	Creatine supple... Resistance trai...	18 Years - 60 Years	University of Deusto
Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study	NCT00597532	Breast Cancer	Soy Milk	-	Memorial Sloan Kettering Cancer Center
Creatine Supplementation and Resistance Training in Patients With Breast Cancer	NCT05878106	Breast Cancer Supplementation Resistance Trai... Physical Perfor... Quality of Life	Creatine supple... Resistance trai...	18 Years - 60 Years	University of Deusto

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