Creatine Supplementation and Resistance Training in Patients With Breast Cancer
NCT05878106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2024-05-09
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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