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Effect of Coenzyme Q10 (COQ10) on Chemotherapeutic Toxicity in Cancer Patients
investigating the potential effect of Coenzyme Q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast cancer patients
Fifty female patients with newly diagnosed breast cancer scheduled for weekly paclitaxel chemotherapy (80 mg/m2) will be randomized in a 1:1 ratio. The CoQ10 Group will receive Coenzyme Q10 supplementation (200 mg twice daily) for twelve weeks, while the Control Group will receive standard chemotherapy alone. Safety monitoring for chemotherapy-related toxicities will be conducted using a multi-modal approach. Laboratory assessments, including complete blood counts (CBC) with differential, liver function, and renal function tests, will be obtained at baseline and prior to each weekly treatment cycle. Echocardiography will be performed at baseline and upon completion of the final cycle. Hematological and non-hematological adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Non-hematological events (including fatigue, neuropathy, and gastrointestinal symptoms) will be captured via structured face-to-face interviews before each chemotherapy session and supplemented by a structured telephone follow-up three days after each session to reduce recall bias. Alopecia and nail changes will be monitored at baseline and at the end of the 12-week chemotherapy course.
Age
18 - 70 years
Sex
FEMALE
Healthy Volunteers
No
Damanhour Oncology Center
Damanhūr, Egypt
Start Date
August 1, 2024
Primary Completion Date
March 10, 2025
Completion Date
March 30, 2025
Last Updated
December 26, 2025
40
ACTUAL participants
Placebo
DRUG
Coenzyme Q10 200mg twice daily
DRUG
Lead Sponsor
Damanhour University
NCT04704661
NCT05245812
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