Breast CancerPhase 2Co-Pa-NNCT07307911
Coenzyme Q10 for Neuroprotection in Paclitaxel-Induced Neuropathy
A Phase 2 study testing Coenzyme Q 10 and Paclitaxel in people with Breast Cancer, run by Damanhour University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Coenzyme Q 10 and Paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2025to 10 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroprotective Effects of Coenzyme Q10 in Paclitaxel-Induced Peripheral Neuropathy
- 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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Coenzyme Q 10, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q 10Dietary supplement
Coenzyme Q10 200 mg orally twice daily for twelve weeks, for CoQ 10 grpup only
PaclitaxelDrug
: Paclitaxel 80 mg/m² administered weekly for twelve weeks to Control and CoQ groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Coenzyme Q 10; Drug: Paclitaxel |
| 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. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).
Secondary outcomes (5)
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.
Measured: Baseline , week 3, week 6, week 9 and week 12
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
Measured: 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
Measured: : 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
Measured: 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.
Measured: Week 6 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start10 Nov 2025
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307911
- Sponsor's protocol ID
- CoQ10-PN-2025-01
- Acronym
- Co-Pa-N
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effects of Coenzyme Q10 in Paclitaxel-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07307911
- Acronym / sponsor ID
- Co-Pa-N / CoQ10-PN-2025-01
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoQ10 group | Experimental | Dietary Supplement: Coenzyme Q 10, Drug: PaclitaxelParticipants 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. |
| Control group | Placebo comparator | Drug: PaclitaxelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding.
- Severe cardiovascular disease (left ventricular ejection fraction <55%).
- Hereditary muscle disorders.
- Diabetes mellitus or history of alcoholism.
- Thyroid dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q 10Coenzyme Q10 200 mg orally twice daily for twelve weeks, for CoQ 10 grpup only | Dietary supplement | CoQ10 group |
| Paclitaxel: Paclitaxel 80 mg/m² administered weekly for twelve weeks to Control and CoQ groups | Drug | CoQ10 group, Control group |
Primary outcome
Change from Baseline in Serum Nerve Growth Factor (NGF) Levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
5 secondary outcomes
Incidence of Paclitaxel-Induced Peripheral Neuropathy
Time frame: Baseline , week 3, week 6, week 9 and week 12
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-item questionnaire (FACT/GOG-Ntx12)
Time frame: Baseline, week 3, week 6, week 9, and week 12.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: : Baseline, week 3, week 6, week 9, and week 12.
Numeric Rating Scale (NRS) for Neuropathic Pain
Time frame: Baseline, week 3, week 6, week 9, and week 12.
Brief Pain Inventory (BPI)-Short Form
Time frame: Week 6 and week 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coenzyme Q 10 and Paclitaxel in people with Breast Cancer, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Serum Nerve Growth Factor (NGF) Levels (time frame: Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.