Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients

Damanhour University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Chemotherapeutic Toxicity

Treatments: Drug: Coenzyme Q10 200mg twice daily; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06570811

COQ10 Breast Cancer Study

Details and patient eligibility

About

investigating the potential effect of Coenzyme Q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast cancer patients

Full description

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. women with newly diagnosed breast cancer r ≥18 years old.
2. Naive to chemotherapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status from 0-2

Exclusion criteria

1. Advanced liver disease (defined as liver enzyme elevation >3-fold upper limit of normality, or cirrhosis); chronic kidney disease (CKD, defined as an estimated glomerular filtration rate (eGFR) <60 ml min-1 1.73 m-2).
2. Patients with a history of allergy to Coenzyme Q10 and similar compounds.
3. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication.
4. Pregnancy or breast feeding.
5. hereditary muscle disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Placebo Comparator

Experimental group

Description:

Placebo Group: 20 patients will receive 80 mg/m2 of paclitaxel chemotherapy weekly for 12 weeks after receiving 4 cycles of AC protocol (Adriamycin and cyclophosphamide)

Treatment:

Drug: Placebo

Active Comparator

Experimental group

Description:

Coenzyme Q10 Group : 20 patients will receive paclitaxel weekly for 12 weeks after receiving 4 cycles of AC protocol (Adriamycin and cyclophosphamide) in addition to oral 200 mg Coenzyme Q10 twice daily for 3 months.

Treatment:

Drug: Coenzyme Q10 200mg twice daily