Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients

Phase 2

Recruiting

• Conditions: Breast Cancer; Chemotherapeutic Toxicity
• Interventions: Drug: Coenzyme Q10 200mg twice daily; Drug: Placebo

• Registration Number: NCT06570811
• Lead Sponsor: Damanhour University

Brief Summary

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

Detailed Description

1. Ethical committee approval is obtained from ethics committee of Faculty of Pharmacy, Damanhour University.

2. All participants should agree to take part in this clinical study and will provide informed consent.

3. Forty female patients with newly diagnosed breast cancer who are candidates for will be recruited from Damanhour oncology center.

4. All enrolled patients will be randomly assigned into two arms:

* Control arm (n=20): will receive 80 mg/m2 of paclitaxel chemotherapy weekly for 4 cycles (12 weeks) after receiving 4 cycles of Adriamycin and cyclophosphamide (AC) protocol

* Treatment arm (n=20): will receive the same regimen as control arm in addition to Coenzyme Q10 400 mg daily (200 mg twice daily).

5. All patients will be submitted to:

* Full patient history and clinical examination.

* Routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests).

* Assessing the effect of coenzyme Q10 on the following: fatigue, sleep disturbance, peripheral neuropathy, nausea , vomiting , mucositis, Anemia , febrile neutropenia and pruritis using common terminology criteria for adverse event (NCI-CTCAE) version 5.

* Assessing of the patient's QoL by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity (FACT-GOG-NTx) subscale

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-01
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	Coenzyme Q10 200mg twice daily	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.
Placebo Comparator	Placebo	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)

Primary Outcome Measures

Name	Time	Method
Clinical assessment of the possible effect of COQ10 on some of the expected paclitaxel adverse events using grading system provided by Common Terminology Criteria for Adverse Events (CTCAE) version 5 (V5)	3 months	The primary endpoint is assessing the effect of coenzyme Q10 on the severity grades of the following adverse events : fatigue, sleep disturbance, peripheral neuropathy, nausea , vomiting , mucositis, Anemia , febrile neutropenia and pruritis.using the severity grades of common terminology criteria for adverse event (NCI-CTCAE) versión 5.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; grades are documented at baseline and weekly over 3 months.
The possible impact of COQ10 on peripheral neuropathy affecting patients' quality of life using Neurotoxicity-12 item questionnaire score (Ntx-12) from Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG-Ntx-12)	3 months	The questionnaire is comprised of statements intended to measure the possible impact of COQ10 on peripheral sensory neuropathy symptoms interfering with patients' lives, which includes numbness or tingling in hands or feet, discomfort in hands or feet, joint pain, general weakness, trouble hearing, ringing or buzzing in ears, trouble with buttons, trouble feeling shape of objects in hands, trouble with walking, and pain in hands or feet when exposed to cold temperatures. At each cycle, each patient is instructed to choose severity of discomfort he feels with (0) indicating not at all; (1), a little bit; (2), somewhat; (3), quite a bit; and (4), very much. The sum of the score is obtained, This sum ranges from 0 to 48. The higher the score, the more severe is the neuropathy and a worse QOL

Trial Locations

Locations (1)

Damanhour Oncology Center; 🇪🇬 Damanhūr, Egypt