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.

Resistance training

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

Symptoms and General Pathology

Musculoskeletal Diseases

Nervous System Diseases

Asthenia

Muscle Weakness

Paresis

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Nicotine

Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.

Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above).

Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol.

Darpan I Patel, PhD

The purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.

The primary objective of this study is to determine the effects of creatine supplementation in modulating strength and physical function in breast cancer survivors that have recently completed chemotherapy. The primary hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.

This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Patients eligible to participate in this study will be allocated to either the creatine group or the control group (1:1) based on a pre-determined randomization list. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.

Effects of Creatine Supplementation in Breast Cancer Survivors

The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors

Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.

Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).

Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.

Magnetic resonance imaging will be used to capture the mid-thigh cross section.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
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
Effects of Creatine Supplementation in Breast Cancer Survivors	NCT04207359	Breast Cancer Chemotherapy Ef... Muscle Weakness Muscle Loss Exercise	Creatine	18 Years - 75 Years	The University of Texas Health Science Center at San Antonio

Spots Global Cancer Trial Database for creatine supplementation