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Trial Title:
Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients
NCT ID:
NCT06570811
Condition:
Breast Cancer
Chemotherapeutic Toxicity
Conditions: Official terms:
Breast Neoplasms
Ubiquinone
Coenzyme Q10
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study is a parallel study
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
This is an open label study where Patients will be classified as follow:
Control arm :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 arm : 20 Patients will receive the same regimen as group1 in addition to 200 mg
Coenzyme Q10 twice daily for 3 months
Intervention:
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo tablets is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel
(taxol®) chemotherapy.
Arm group label:
Placebo Comparator
Intervention type:
Drug
Intervention name:
Coenzyme Q10 200mg twice daily
Description:
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.
Arm group label:
Active Comparator
Other name:
Coenzyme Q10 (Ubiquinol) -200mg ®
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
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Female breast cancer patients
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Damanhour Oncology Center
Address:
City:
Damanhūr
Zip:
22511
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Damanhour Oncology center
Investigator:
Last name:
Gehad Hassoub, Demonstrator
Email:
Principal Investigator
Start date:
August 1, 2024
Completion date:
March 2025
Lead sponsor:
Agency:
Damanhour University
Agency class:
Other
Source:
Damanhour University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06570811
