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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoQ10 group | Experimental | 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. |
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| Control group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme Q 10 | Dietary Supplement | Coenzyme Q10 200 mg orally twice daily for twelve weeks, for CoQ 10 grpup only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Serum Nerve Growth Factor (NGF) Levels | 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 | Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12). |
| Change from Baseline in Serum Neurofilament Light Chain (NFL) Levels | 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 | Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12). |
| Change from Baseline in Serum Osteopontin (OPN) Levels | 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. | Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12). |
| Change from Baseline in Serum Malondialdehyde (MDA) Levels | 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 | Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Paclitaxel-Induced Peripheral Neuropathy | The occurrence of peripheral neuropathy in patients receiving paclitaxel chemotherapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6. This will evaluate the onset and severity of neuropathy symptoms, including numbness, tingling, and pain in hands and feet. | Baseline , week 3, week 6, week 9 and week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhur Oncology Center | Damanhūr | 22511 | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | : Paclitaxel 80 mg/m² administered weekly for twelve weeks to Control and CoQ groups |
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| Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-item questionnaire (FACT/GOG-Ntx12) | A 12-item questionnaire used to assess the impact of peripheral neuropathy on daily functioning. Each item is scored from 0 ("not at all") to 4 ("very much"). The total score is calculated by multiplying the sum of individual item scores by 12 and dividing by the number of items completed. Scores range from 0 to 48. Higher scores indicate better neuropathy-related quality of life | Baseline, week 3, week 6, week 9, and week 12. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | A 13-item scale evaluating fatigue severity. Each item is scored on a 0-4 Likert scale. Total scores are calculated by summing individual item scores, multiplying by 13, and dividing by the number of items completed. Scores range from 0 to 52. Higher FACIT-F scores indicate less fatigue and better quality of life | : Baseline, week 3, week 6, week 9, and week 12. |
| Numeric Rating Scale (NRS) for Neuropathic Pain | 0-10 numeric rating 0 = no pain; 10 = worst imaginable pain | Baseline, week 3, week 6, week 9, and week 12. |
| Brief Pain Inventory (BPI)-Short Form | The BPI assesses pain severity (4 items) and interference with daily activities (7 items). Each item is rated on a 0-10 scale. A total pain severity score is calculated by averaging the severity items, and an interference score is calculated by averaging the interference items. Scores range from 0 to 10. Higher scores indicate greater pain intensity and interference with daily life. | Week 6 and week 12. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |