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临床试验/NCT06570811
NCT06570811已完成2 期

Effect of Coenzyme Q10 (COQ10) on Chemotherapeutic Toxicity in Cancer Patients

Damanhour University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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).
  • Patients with a history of allergy to Coenzyme Q10 and similar compounds.
  • Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication.
  • Pregnancy or breast feeding.
  • hereditary muscle disorders.

研究组 & 干预措施

Placebo Comparator

Experimental

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)

干预措施: Placebo (Drug)

Active Comparator

Experimental

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.

干预措施: Coenzyme Q10 200mg twice daily (Drug)

结局指标

主要结局

Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

时间窗: 3 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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