Neuroprotective Effects of Coenzyme Q10 in Paclitaxel-Induced Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in Serum Nerve Growth Factor (NGF) Levels
研究概览
简要总结
- This study aims to investigate whether Coenzyme Q10 supplementation can reduce chemotherapy-induced peripheral neuropathy, fatigue, and pain in women with newly diagnosed breast cancer receiving paclitaxel treatment. The study will also examine the effects of Coenzyme Q10 on biomarkers associated with nerve damage. The main questions it seeks to answer are:
- Does Coenzyme Q10 improve patients' quality of life by reducing neuropathy, fatigue, and pain during chemotherapy?
- How does Coenzyme Q10 affect serum levels of nerve growth factor, neurofilament light chain, malondialdehyde, and osteopontin during treatment?
- Participants will: Receive either Coenzyme Q10 along with standard weekly paclitaxel chemotherapy or paclitaxel alone for twelve weeks.
- Complete questionnaires on neuropathy, fatigue, and pain at the end of each chemotherapy cycle.
- Provide blood samples at the beginning and end of the study to measure biomarkers of nerve injury.
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 into two study arms. The CoQ10 Group will receive Coenzyme Q10 supplementation (200 mg twice daily) for twelve weeks in addition to the standard chemotherapy protocol, while the Control Group will receive the standard chemotherapy protocol alone.
Clinical assessments for peripheral neuropathy, including grading via NCI-CTCAE v5.0, will be conducted prior to the initiation of each weekly paclitaxel session to monitor for symptom onset and severity. Patient-reported outcome measures for neuropathy-specific quality of life (FACT/GOG-Ntx12), fatigue (FACIT-F), and pain intensity (VAS) will be administered at baseline and at the end of weeks 3, 6, 9, and 12. To specifically assess pain interference and severity over time, the Brief Pain Inventory (BPI) will be administered at week 6 and week 12.
For the exploratory biomarker analysis, 5 mL of venous blood will be collected via antecubital venipuncture at baseline (one hour before the first cycle) and one hour after the final paclitaxel dose. Samples will be allowed to clot at room temperature for 30 minutes, then centrifuged at 3,000 rpm for 15 minutes. The resulting serum will be aliquoted and stored at -80 degrees Celsius. Biochemical quantification of NGF, NfL, and OPN will be performed using double-antibody sandwich ELISA, and MDA levels will be determined via colorimetric assay to evaluate oxidative stress and axonal integrity. All participants will be followed for a total of 90 days from the start of treatment to evaluate the time to development of Grade 2 or 3 neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 years or older with newly diagnosed breast cancer.
- •Chemotherapy-naïve (have not received prior chemotherapy).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
排除标准
- •Pregnancy or breastfeeding.
- •Severe cardiovascular disease (left ventricular ejection fraction <55%).
- •Hereditary muscle disorders.
- •Diabetes mellitus or history of alcoholism.
- •Thyroid dysfunction.
- •History of allergy to Coenzyme Q10 or related compounds.
- •Advanced liver disease (liver enzyme elevation >3× upper limit of normal or cirrhosis).
- •Chronic kidney disease (CKD), defined as estimated glomerular filtration rate <60 mL/min/m².
研究组 & 干预措施
CoQ10 group
Participants in this arm will receive standard weekly paclitaxel chemotherapy (80 mg/m²) for twelve weeks in combination with Coenzyme Q10 supplementation at 200 mg twice daily. The purpose of this arm is to evaluate the effect of Coenzyme Q10 on chemotherapy-induced peripheral neuropathy, fatigue, pain, and related serum biomarkers.
干预措施: Paclitaxel (Drug)
CoQ10 group
Participants in this arm will receive standard weekly paclitaxel chemotherapy (80 mg/m²) for twelve weeks in combination with Coenzyme Q10 supplementation at 200 mg twice daily. The purpose of this arm is to evaluate the effect of Coenzyme Q10 on chemotherapy-induced peripheral neuropathy, fatigue, pain, and related serum biomarkers.
干预措施: Coenzyme Q 10 (Dietary Supplement)
Control group
Participants in this arm will receive standard weekly paclitaxel chemotherapy (80 mg/m²) for twelve weeks without Coenzyme Q10 supplementation. This arm serves as a comparator to evaluate the effects of Coenzyme Q10 on chemotherapy-induced peripheral neuropathy, fatigue, pain, and related serum biomarkers.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Change from Baseline in Serum Nerve Growth Factor (NGF) Levels
时间窗: Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).
Serum NGF levels will be quantified using a double-antibody sandwich ELISA kit to assess neurotrophic status.Unit of Measure: picograms per milliliter (pg/mL).Higher levels are generally associated with nerve repair/regeneration
Change from Baseline in Serum Neurofilament Light Chain (NFL) Levels
时间窗: Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).
Serum NFL levels will be measured via ELISA as a biomarker of axonal injury and neurodegeneration.Unit of Measure: picograms per milliliter (pg/mL).Higher levels indicate greater degrees of neuronal damage
Change from Baseline in Serum Osteopontin (OPN) Levels
时间窗: Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).
Serum OPN levels will be quantified using a double-antibody sandwich ELISA kit.Unit of Measure: nanograms per milliliter (ng/mL).low OPN is linked to worse neuropathy.
Change from Baseline in Serum Malondialdehyde (MDA) Levels
时间窗: Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).
MDA will be measured as a marker of lipid peroxidation and oxidative stress using a colorimetric assay kit.Unit of Measure: nanomoles per milliliter (nmol/mL).Higher levels indicate increased oxidative stress
次要结局
- Brief Pain Inventory (BPI)-Short Form(Week 6 and week 12.)
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-item questionnaire (FACT/GOG-Ntx12)(Baseline, week 3, week 6, week 9, and week 12.)
- Numeric Rating Scale (NRS) for Neuropathic Pain(Baseline, week 3, week 6, week 9, and week 12.)
- Incidence of Paclitaxel-Induced Peripheral Neuropathy(Baseline , week 3, week 6, week 9 and week 12)
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(: Baseline, week 3, week 6, week 9, and week 12.)