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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Placebo tablets is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel (taxol®) chemotherapy.
400 mg daily (200mg twice daily) of Coenzyme Q10 (an antioxidant that's in many foods, and it's made naturally in the investigator's bodies) is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel (taxol®) chemotherapy.
Damanhour Oncology Center
Damanhūr, Egypt
Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
The primary endpoint is Identtifying he number of participants experiencing chemotherapy-related toxicities including fatigue, sleep disturbance, peripheral neuropathy, nausea, vomiting, mucositis, anemia, febrile neutropenia, and pruritus. Grading is based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.The grades as follow * Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate Instrumental activities of daily living (IADL) * Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. * Grade 4 Life-threatening consequences; urgent intervention indicated. * Grade 5 Death
Time frame: 3 months
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