Creatine and resistance training for breast cancer patients
Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study)
This study is testing if taking creatine along with a 16-week strength training program can help women with early-stage breast cancer feel stronger and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Deusto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bilbao, Bizkaia) |
| Trial ID | NCT05878106 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a 16-week supervised resistance training program combined with creatine supplementation in patients with early-stage breast cancer. It is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the impact of creatine on physical performance and quality of life. Participants will be divided into three groups: a control group and two experimental groups receiving different interventions. The goal is to determine if creatine enhances the benefits of resistance training in this population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-60 with early-stage breast cancer who have completed local treatment and are in outpatient follow-up.
Not a fit: Patients with metastatic breast cancer or those who have received chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve physical performance and quality of life for breast cancer patients undergoing treatment.
How similar studies have performed: While the specific combination of creatine and resistance training in breast cancer patients is novel, previous studies have shown positive outcomes with resistance training in cancer populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bilbao, Bizkaia
- Hospital de Cruces — Bilbao, Bizkaia, Spain (Recruiting)
Study contacts
- Principal investigator: Arkaitz Castañeda, PhD — University of Deusto
- Study coordinator: Arkaitz Castañeda, PhD
- Email: arkaitz.castaneda@deusto.es
- Phone: 944139003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.