A Phase 3 interventional study of Creatine and Placebo in Breast Cancer, sponsored by D'Or Institute for Research and Education. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by D'Or Institute for Research and Education · Phase 3, Interventional, and Supportive care
The goal of this clinical trial is to evaluate whether oral creatine supplementation can prevent chemotherapy-related cognitive impairment in patients with early-stage breast cancer undergoing neoadjuvant or adjuvant chemotherapy. The main questions it aims to answer are:
Researchers will compare creatine supplementation (5 g/day) with placebo to assess differences in cognitive outcomes, safety, and exploratory biological markers.
Participants will:
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 227 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →D'Or Institute for Research and Education is the lead sponsor of 42 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants assigned to this arm will receive a placebo powder matched in appearance, taste, and packaging to the investigational product. The placebo will be administered orally once daily, dissolved in water, starting 7 days before the first cycle of chemotherapy and continuing until 12 months after completion of chemotherapy.
Other: Placebo
Participants assigned to this arm will receive oral creatine monohydrate at a dose of 5 g per day, dissolved in water and administered once daily. Treatment will begin 7 days before the first cycle of chemotherapy and will continue until 12 months after completion of chemotherapy.
Drug: Creatine
Oral creatine monohydrate supplementation administered at a fixed dose of 5 g per day, dissolved in water and taken once daily. The intervention starts 7 days before initiation of neoadjuvant or adjuvant chemotherapy and continues through chemotherapy and up to 12 months after chemotherapy completion. The intervention is designed to evaluate the preventive effect of creatine on chemotherapy-related cognitive impairment, with longitudinal cognitive, clinical, imaging, and translational assessments. The comparator is a matched placebo identical in appearance, taste, and packaging.
Oral placebo powder matched in appearance, taste, and packaging to the investigational product, administered once daily dissolved in water. The placebo is initiated 7 days before the start of neoadjuvant or adjuvant chemotherapy and continued through chemotherapy and up to 12 months after chemotherapy completion. The placebo contains no active ingredients and is used as the comparator to assess the preventive effect of creatine supplementation on chemotherapy-related cognitive impairment.
Change in patient-reported cognitive function
Measured by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), version 3, from baseline to 1 month after completion of chemotherapy. A clinically significant cognitive decline is defined as a decrease of at least 7.5 points in the total FACT-Cog score.
Time frame: Baseline and 1 month after completion of chemotherapy
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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D'Or Institute for Research and Education