Actively Recruiting
Creatine Supplementation and Resistance Training in Patients With Breast Cancer
Led by University of Deusto · Updated on 2024-05-09
120
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
U
University of Deusto
Lead Sponsor
H
Hospital de Cruces
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Creatine Supplementation and Resistance Training in Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of early-stage breast cancer (Stage pTis-T1-T2-T3 pN0-1 M0)
- Completed local treatment including surgery and radiotherapy
- Undergoing clinical follow-up with or without adjuvant hormone therapy
- Age between 18 and 60 years
- ECOG Performance status between 0 and 1 (IK 60%)
- Body mass index above 18.5
- No excessive alcohol consumption (men 21 units/week; women 14 units/week)
- No current or previous illness or injury preventing participation or training
- No recent systematic strength training
- Not taking medications known to alter body composition (e.g., corticosteroids, metformin)
- Aerobic training allowed and will be recorded weekly
You will not qualify if you...
- Received adjuvant or neoadjuvant chemotherapy
- Metastatic breast carcinoma
- Recurrence or second primary breast cancer
- History of previous cancer except treated basal cell carcinoma of the skin
- Decompensated heart disease, uncontrolled hypertension (TAS >200 or TAD >110), heart failure (NYHA II or greater), or constrictive pericarditis
- Neutropenia, severe anemia (Hb <8.0 g/dl), or platelet count <50,000 microL
- Other health problems where exercise is contraindicated
- Performing regular physical activity of 150 min/week moderate or 75 min/week vigorous activity
- Pregnancy
- Inability to understand study involvement or participation as judged by the investigator
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Trial Site Locations
Total: 1 location
1
Hospital de Cruces
Bilbao, Bizkaia, Spain, 48080
Actively Recruiting
Research Team
A
Arkaitz Castañeda, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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