Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570811
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Coenzyme Q10 COQ10 on Chemotherapeutic Toxicity in Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n20 will receive 80 mgm2 of paclitaxel chemotherapy weekly for 4 cycles 12 weeks after receiving 4 cycles of Adriamycin and cyclophosphamide AC protocol
Treatment arm n20 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 patients QoL by the Functional Assessment of Cancer TherapyGynecologic Oncology Group Neurotoxicity FACT-GOG-NTx subscale
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 n20 will receive 80 mgm2 of paclitaxel chemotherapy weekly for 4 cycles 12 weeks after receiving 4 cycles of Adriamycin and cyclophosphamide AC protocol
Treatment arm n20 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 patients QoL by the Functional Assessment of Cancer TherapyGynecologic Oncology Group Neurotoxicity FACT-GOG-NTx subscale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None