Creatine Supplementation and Resistance Training in Patients With Breast Cancer

NCT05878106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-09

No results posted yet for this study

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.

Conditions

  • Breast Cancer
  • Supplementation
  • Resistance Training
  • Physical Performance
  • Quality of Life

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

Resistance 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.

Sponsors & Collaborators

  • Hospital de Cruces

    collaborator OTHER
  • Hospital de Basurto

    collaborator OTHER
  • Poznan University of Medical Sciences

    collaborator OTHER
  • Hospital Universitario de Burgos

    collaborator OTHER
  • University of Calabria

    collaborator OTHER
  • University of Deusto

    lead OTHER

Principal Investigators

  • Arkaitz Castañeda, PhD · University of Deusto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2025-04-20
Completion
2025-12-08

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05878106 on ClinicalTrials.gov