RecruitingNot ApplicableNCT05878106

Creatine Supplementation and Resistance Training in Patients With Breast Cancer

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


Sponsor

University of Deusto

Enrollment

120 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether combining creatine supplements with resistance (strength) training can help early-stage breast cancer survivors rebuild muscle strength and improve body composition after completing their local treatment (surgery and radiation). Creatine is a natural supplement that may support muscle function during exercise. **You may be eligible if...** - You are a woman aged 18–60 with early-stage breast cancer (stage I–III, non-metastatic) - You have completed surgery and radiation therapy and are in follow-up care - You may or may not be on hormone therapy - You have not been doing regular strength training recently - Your body mass index is above 18.5 and you do not drink excessively **You may NOT be eligible if...** - You received adjuvant or neoadjuvant chemotherapy - Your cancer has spread (metastatic) or has recurred - You have heart disease, uncontrolled high blood pressure, severe anemia, or other conditions that make exercise unsafe - You are already doing more than 150 minutes of moderate exercise per week - You are pregnant - You are taking medications known to affect body composition (steroids, metformin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTCreatine 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.

OTHERResistance training

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.


Locations(1)

Hospital de Cruces

Bilbao, Bizkaia, Spain

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NCT05878106


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