Influence of Creatine supplementation with or without remote physical training on the reduction of sarcopenia and fatigue in women with Breast cancer treated with neoadjuvant Chemotherapy: a triple-blind, placebo-controlled randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18Y 至 0（—）
- 性别
- Female
入选标准
- •Women; aged 18 years or older; diagnosis of stage II, III, or IV breast cancer; prescribed neoadjuvant chemotherapy; treatment with chemotherapy regimens containing anthracyclines (doxorubicin or epirubicin), alkylating agents (cyclophosphamide), or taxanes (paclitaxel or docetaxel); treatment with AC (doxorubicin + cyclophosphamide), AC-T (doxorubicin + cyclophosphamide followed by paclitaxel or docetaxel), or DC (docetaxel + cyclophosphamide) regimens.
排除标准
- •History of tumor recurrence; renal insufficiency; hepatic insufficiency; breast cancer as a second primary malignancy; no access to WhatsApp; cognitive impairment; withdrawal from the study; progression to palliative care; need for surgery before the time scheduled in the study protocol.
研究组 & 干预措施
This is a randomized, placebo-controlled, double-blind, crossover clinical trial. The study will include 108 women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy, randomized into three groups of 36 participants each. Group 1 will perform supervised remote physical training during four chemotherapy cycles, receiving creatine supplementation (5 g/day) during the first two cycles and a placebo during the subsequent two cycles. Group 2 will perform supervised remote physical training during four chemotherapy cycles, receiving a placebo during the first two cycles and creatine supplementation (5 g/day) during the subsequent two cycles. Group 3 will perform unsupervised remote physical training during four chemotherapy cycles, receiving a placebo (5 g/day) throughout the entire intervention period. Chemotherapy cycles will occur at 21-day intervals. Exercise protocols will be conducted via the MFIT PERSONAL® app under the supervision of a qualified physical education professional. Creatine and placebo will be prepared in identical sachets containing 5 g each to ensure participant blinding. Blinding will apply to both participants and researchers responsible for outcome assessment, with group allocation remaining concealed until the analyses are completed.
干预措施: This is a randomized, placebo-controlled, double-blind, crossover clinical trial. The study will include 108 women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy, randomized into three groups of 36 participants each. Group 1 will perform supervised remote physical training during four chemotherapy cycles, receiving creatine supplementation (5 g/day) during the first two cycles and a placebo during the subsequent two cycles. Group 2 will perform supervised remote physical training during four chemotherapy cycles, receiving a placebo during the first two cycles and creatine supplementation (5 g/day) during the subsequent two cycles. Group 3 will perform unsupervised remote physical training during four chemotherapy cycles, receiving a placebo (5 g/day) throughout the entire intervention period. Chemotherapy cycles will occur at 21-day intervals. Exercise protocols will be conducted via the MFIT PERSONAL® app under the supervision of a qualified physical education professional. Creatine and placebo will be prepared in identical sachets containing 5 g each to ensure participant blinding. Blinding will apply to both participants and researchers responsible for outcome assessment, with group allocation remaining concealed until the analyses are completed.