Peripheral Neuropathy, Chemotherapy-inducedNCT07191587
A Controlled Clinical Trial Assessing the Efficacy of Vitamin B Prophylaxis in Attenuating Paclitaxel-induced Neuropathy and the Imperative Use of Gabapentin in Diabetic Ovarian Cancer Patients and the Potential Effect on Disease Response.
A study testing Vitamin B Complex in people with Peripheral Neuropathy, Chemotherapy-induced and Disease Management, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if vitamin B prophylaxis is effective in attenuating chemotherapy-induced peripheral neuropathy in adult ovarian cancer patients. The main questions (primary outcomes) it aims to answer are: The severity of chemotherapy-induced peripheral neuropathy in ovarian cancer… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripheral Neuropathy, Chemotherapy-induced, Disease Management
- What is being tested?
- Vitamin B Complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 May 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with confirmed pathology of ovarian adenocarcinoma.
- Aged 18 years or older.
- Scheduled to receive a weekly paclitaxel-based chemotherapy regimen (80 mg/m²).
Who cannot join
- Individuals under 18 years of age.
- Any patients with pre-existing peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin B Prophylaxis Effect on Peripheral Neuropathy Induced in Ovarian Cancer Patients Receiving Paclitaxel Based Regimen.
The goal of this clinical trial is to learn if vitamin B prophylaxis is effective in attenuating chemotherapy-induced peripheral neuropathy in adult ovarian cancer patients. The main questions (primary outcomes) it aims to answer are:
- The severity of chemotherapy-induced peripheral neuropathy in ovarian cancer patients undergoing a weekly paclitaxel-based regimen in the vitamin B prophylactic group versus non-prophylactic group.
- Severity of chemotherapy-induced peripheral neuropathy in diabetic patients versus non-diabetic patients in both prophylactic and non-prophylactic groups.
Read more
Participants will:
Take drug oral vitamin B complex every day as prophylaxis for 6 months. Visit the clinic once every week for their weekly Paclitaxel regimen, checkups and tests.
Keep a diary of their symptoms.
Read the detailed description
Patients received oral vitamin B complex as prophylaxis prior to starting their paclitaxel-based regimen and patients in the non-prophylaxis group received oral vitamin B complex upon developing chemotherapy-induced peripheral neuropathy during their treatment with paclitaxel-base regimen. Gabapentin was given to the patients in either groups upon aggravation of CIPN symptoms whether in severity or neuropathic pain according to peripheral neuropathy grading.
Secondary outcomes:
- The number of patients in both prophylactic and non-prophylactic groups who required Gabapentin upon uncontrolled or aggravation in CIPN with vitamin B complex only.
- Impact of vitamin B complex prophylaxis on dose modification of paclitaxel-based regimen.
- Association between dose modification and CA 125 status.
- Progression-free survival (PFS) was evaluated at the end of the study.
- Being tested
- Vitamin B Complex
- Keywords
- Vitamin B, Paclitaxel-induced peripheral neuropathy, Ovarian cancer, Diabetic, Gabapentin
- Medical subject headings
- Peripheral Nervous System Diseases, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B ComplexDietary supplement
Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic arm | Active comparator | In this arm, patients were given oral vitamin B prophylaxis prior to their first cycle of chemotherapy. Receives: Dietary Supplement: Vitamin B Complex |
| Non-prophylactic arm | Other | In this arm, patients were given oral vitamin B upon developing chemotherapy-induced peripheral neuropathy. Receives: Dietary Supplement: Vitamin B Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade)
The primary outcome of this study was the severity of chemotherapy-induced peripheral neuropathy in ovarian cancer patients undergoing a weekly paclitaxel-based regimen in the vitamin B prophylactic group versus non-prophylactic group. Severity was assessed by assessed by CTCAE v4.0 through monitoring the occurrence of peripheral neuropathy symptoms (peripheral neuropathy grade) at baseline and on weekly basis, up to 18 weeks (last follow up for chemotherapy induced peripheral neuropathy).
Measured: At baseline and up to 18 weeks.
Secondary outcomes (5)
Number of participants with paclitaxel induced peripheral neuropathy as assessed by CTCAE v4.0 in both prophylactic and non-prophylactic groups who required Gabapentin upon uncontrolled or aggravation in neuropathy grade with vitamin B complex only.
Measured: After the first week and up to 18 weeks.
Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade) as assessed by CTCAE v4.0 in diabetic patients versus non-diabetic patients in both prophylactic and non-prophylactic groups.
Measured: At baseline and up to 18 weeks.
Percentage of patients that underwent dose modification in their paclitaxel regimen in both prophylactic and non-prophylactic groups due to chemotherapy-induced peripheral neuropathy as assessed by CTCAE v4.0".
Measured: After the first week and up to 18 weeks.
Association between dose modification in paclitaxel regimen and CA125 status as measured by improved or worsened CA125 status.
The CA125 status after dose modification in paclitaxel regimen due to chemotherapy-induced peripheral neuropathy or other hematological toxicities.
Measured: up to 20 weeks.
Progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Dec 2024
- Primary completion30 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy, Chemotherapy-inducedStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191587
- Sponsor's protocol ID
- MO2411-505-068-193
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin B Prophylaxis Effect on Peripheral Neuropathy Induced in Ovarian Cancer Patients Receiving Paclitaxel Based Regimen.
- ClinicalTrials.gov ID
- NCT07191587
- Acronym / sponsor ID
- MO2411-505-068-193
- Keywords
- Vitamin B, Paclitaxel-induced peripheral neuropathy, Ovarian cancer, Diabetic, Gabapentin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 25 Sep 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.
The goal of this clinical trial is to learn if vitamin B prophylaxis is effective in attenuating chemotherapy-induced peripheral neuropathy in adult ovarian cancer patients. The main questions (primary outcomes) it aims to answer are:
- The severity of chemotherapy-induced peripheral neuropathy in ovarian cancer patients undergoing a weekly paclitaxel-based regimen in the vitamin B prophylactic group versus non-prophylactic group.
- Severity of chemotherapy-induced peripheral neuropathy in diabetic patients versus non-diabetic patients in both prophylactic and non-prophylactic groups.
Participants will:
Take drug oral vitamin B complex every day as prophylaxis for 6 months. Visit the clinic once every week for their weekly Paclitaxel regimen, checkups and tests.
Keep a diary of their symptoms.
Detailed description
Patients received oral vitamin B complex as prophylaxis prior to starting their paclitaxel-based regimen and patients in the non-prophylaxis group received oral vitamin B complex upon developing chemotherapy-induced peripheral neuropathy during their treatment with paclitaxel-base regimen. Gabapentin was given to the patients in either groups upon aggravation of CIPN symptoms whether in severity or neuropathic pain according to peripheral neuropathy grading.
Secondary outcomes:
- The number of patients in both prophylactic and non-prophylactic groups who required Gabapentin upon uncontrolled or aggravation in CIPN with vitamin B complex only.
- Impact of vitamin B complex prophylaxis on dose modification of paclitaxel-based regimen.
- Association between dose modification and CA 125 status.
- Progression-free survival (PFS) was evaluated at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic arm | Active comparator | Dietary Supplement: Vitamin B ComplexIn this arm, patients were given oral vitamin B prophylaxis prior to their first cycle of chemotherapy. |
| Non-prophylactic arm | Other | Dietary Supplement: Vitamin B ComplexIn this arm, patients were given oral vitamin B upon developing chemotherapy-induced peripheral neuropathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients with confirmed pathology of ovarian adenocarcinoma.
- Aged 18 years or older.
- Scheduled to receive a weekly paclitaxel-based chemotherapy regimen (80 mg/m²).
Key exclusion criteria (2 listed)
- Individuals under 18 years of age.
- Any patients with pre-existing peripheral neuropathy.
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 |
|---|---|---|
| Vitamin B ComplexVitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm. | Dietary supplement | Non-prophylactic arm, Prophylactic arm |
Primary outcome
Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade)
Time frame: At baseline and up to 18 weeks.
The primary outcome of this study was the severity of chemotherapy-induced peripheral neuropathy in ovarian cancer patients undergoing a weekly paclitaxel-based regimen in the vitamin B prophylactic group versus non-prophylactic group. Severity was assessed by assessed by CTCAE v4.0 through monitoring the occurrence of peripheral neuropathy symptoms (peripheral neuropathy grade) at baseline and on weekly basis, up to 18 weeks (last follow up for chemotherapy induced peripheral neuropathy).
5 secondary outcomes
Number of participants with paclitaxel induced peripheral neuropathy as assessed by CTCAE v4.0 in both prophylactic and non-prophylactic groups who required Gabapentin upon uncontrolled or aggravation in neuropathy grade with vitamin B complex only.
Time frame: After the first week and up to 18 weeks.
Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade) as assessed by CTCAE v4.0 in diabetic patients versus non-diabetic patients in both prophylactic and non-prophylactic groups.
Time frame: At baseline and up to 18 weeks.
Percentage of patients that underwent dose modification in their paclitaxel regimen in both prophylactic and non-prophylactic groups due to chemotherapy-induced peripheral neuropathy as assessed by CTCAE v4.0".
Time frame: After the first week and up to 18 weeks.
Association between dose modification in paclitaxel regimen and CA125 status as measured by improved or worsened CA125 status.
Time frame: up to 20 weeks.
Progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks.
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 25 Sep 2025.
- Diabetes mellitus as a risk factor for chemotherapy-induced peripheral neuropathy: a meta-analysisLink provided by the sponsor.
- Vitamin B6 status and chronic chemotherapy-induced peripheral neuropathy: a prospective cohort study among patients with non-metastatic colorectal cancer receiving oxaliplatin-based chemotherapyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Peripheral Neuropathy, Chemotherapy-induced
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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 study testing Vitamin B Complex in people with Peripheral Neuropathy, Chemotherapy-induced and Disease Management, run by National Cancer Institute, Egypt 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 2 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 25 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade) (time frame: At baseline and up to 18 weeks.). 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 25 Sep 2025.