Creatine Supplementation and Resistance Training in Patients With Breast Cancer

Launched by UNIVERSITY OF DEUSTO · May 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of creatine supplementation combined with a resistance training program on patients with breast cancer. The main goal is to see if taking creatine along with a 16-week supervised strength training program can improve physical performance and quality of life for these patients. Resistance training, which includes exercises like leg presses and chest presses, is known to help build muscle and strength, especially in cancer patients. In this trial, participants will be randomly assigned to one of three groups: one will do resistance training and receive a placebo, while the other two groups will also do the training but one will receive creatine supplements.

To be eligible for this study, participants should be between 18 and 60 years old and have early-stage breast cancer that has been treated with surgery and possibly radiation. They should not have received chemotherapy recently and should be in relatively good health, meaning they can perform daily activities without issues. Throughout the trial, participants will engage in resistance exercises three times a week and will receive protein supplements as well. This study aims to provide valuable information on how these approaches can help enhance strength and overall well-being in breast cancer patients.

Gender

ALL

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.