To hear about similar clinical trials, please enter your email below
Trial Title:
Creatine Supplementation and Resistance Training in Patients With Breast Cancer
NCT ID:
NCT05878106
Condition:
Breast Cancer
Supplementation
Resistance Training
Physical Performance
Quality of Life
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Creatine supplementation
Description:
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.
Arm group label:
Resistance training and creatine supplementation group
Intervention type:
Other
Intervention name:
Resistance training
Description:
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.
Arm group label:
Resistance training and creatine supplementation group
Arm group label:
Resistance training group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Stage pTis-T1-T2-T3 pN0-1 M0 (early stage).
- Patients who have completed local treatment [surgery + radiotherapy (RT)] undergoing
clinical follow-up in outpatient clinics with or without adjuvant hormone therapy
treatment.
- Age: ≥18-60 years.
- ECOG Performance status from 0 to 1 (IK ≥80%).
- Body mass index above than 18.5.
- Without excessive alcohol consumption (men > 21 and women > 14 units/week).
- No current or previous illness or injury that may prevent participation and
training.
- No recent systematic strength training.
- Not taking medications that are known to alter body composition (corticosteroids,
metformin...).
- People who carry out some aerobic training will not be excluded (the activity
carried out will be recorded weekly).
Exclusion Criteria:
- Having received adjuvant or neoadjuvant chemotherapy.
- Metastatic carcinoma of the breast.
- Recurrence or second primary breast.
- History of previous cancer except previously treated basal cell carcinoma of the
skin.
- Decompensated heart disease, uncontrolled hypertension (TAS>200 or TAD>110), heart
failure (NYHA II or greater), heart failure or constrictive pericarditis,
neutropenia, severe anemia (Hb<8.0 g/dl), blood count platelets <50,000 microL.
- Other health problems in which exercise is contraindicated
- Perform regular physical activity (150 min/week of moderate activity or 75 of
vigorous activity), measured with the PVS questionnaire.
- Pregnancy.
- Criterion in the opinion of the investigator of inability to adequately understand
the involvement and participation in this clinical study.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital de Cruces
Address:
City:
Bilbao
Zip:
48080
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jon Cacicedo, Dr
Email:
JON.CACICEDOFERNANDEZDEBOBADILLA@osakidetza.eus
Start date:
April 8, 2024
Completion date:
December 8, 2025
Lead sponsor:
Agency:
University of Deusto
Agency class:
Other
Collaborator:
Agency:
Hospital de Cruces
Agency class:
Other
Collaborator:
Agency:
Hospital de Basurto
Agency class:
Other
Collaborator:
Agency:
Poznan University of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario de Burgos
Agency class:
Other
Collaborator:
Agency:
University of Calabria
Agency class:
Other
Source:
University of Deusto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05878106
