Peripheral NeuropathyPhase 2NCT05351021
Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
A Phase 2 study testing Metformin in people with Peripheral Neuropathy and Breast Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy, Breast Cancer
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2022to 30 Oct 2022
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years old)
- Early-stage breast cancer patients who will receive adjuvant paclitaxel
- Performance status according to Eastern Cooperative oncology group (ECOG) < 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine<1.5 mg/dl).
Who cannot join
- Clinical neuropathy at prior to enrollment.
- Patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
- Patients with a history of hypersensitivity to metformin.
- Pregnant or lactating females.
- Patients who are using metformin for any other cause.
- Patients with Diabetes mellitus.
- Receiving vitamin B1, B6, B12 or another vitamin supplemental therapy.
- Receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.
Trial locations and contacts
1 site in 1 country.
About this study
At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in cancer patients.
- Conditions
- Peripheral Neuropathy, Breast Cancer
- Being tested
- Metformin, Placebo
- Medical subject headings
- Peripheral Nervous System Diseases, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
cidophage 850 gm twice daily
PlaceboDrug
placebo twice daily for treatment period
| Study group | Role | What they receive |
|---|---|---|
| Group I (metformin group) | Experimental | who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration. Receives: Drug: Metformin |
| Group II (control group) | Placebo comparator | who will receive adjuvant weekly paclitaxel. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment
Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03)
Measured: 8 weeks
Secondary outcomes (4)
Time to develop grade 2or 3 PIPN
The time from randomization till development of grade II or III PN will be recorded for all patients included in the study.
Measured: 8 weeks
the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale
Patient's QOL will be assessed using the validated Arabic version of FACT-GOG-NTX subscale
Measured: 8 weeks
Pain Severity
The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)
Measured: 8 weeks
Serum biomarkers level in (ng/mL)
Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start12 Apr 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351021
- Sponsor's protocol ID
- 2021-375
- Status last verified
- Mar 2023
- First submitted
- 14 Apr 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bakry HM, Mansour NO, ElKhodary TR, Soliman MM. Efficacy of metformin in prevention of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2023 Jul 31;14:1181312. doi: 10.3389/fphar.2023.1181312. eCollection 2023.
PubMed 37583905
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05351021
- Acronym / sponsor ID
- 2021-375
- Conditions
- Peripheral Neuropathy, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 28 Apr 2022 (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.
At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (metformin group) | Experimental | Drug: Metforminwho will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration. |
| Group II (control group) | Placebo comparator | Drug: Placebowho will receive adjuvant weekly paclitaxel. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (>18 years old)
- Early-stage breast cancer patients who will receive adjuvant paclitaxel
- Performance status according to Eastern Cooperative oncology group (ECOG) < 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine<1.5 mg/dl).
Key exclusion criteria (8 listed)
- Clinical neuropathy at prior to enrollment.
- Patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
- Patients with a history of hypersensitivity to metformin.
- Pregnant or lactating females.
- Patients who are using metformin for any other cause.
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 |
|---|---|---|
| Metformincidophage 850 gm twice daily | Drug | Group I (metformin group) |
| Placeboplacebo twice daily for treatment period | Drug | Group II (control group) |
Primary outcome
The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment
Time frame: 8 weeks
Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03)
4 secondary outcomes
Time to develop grade 2or 3 PIPN
Time frame: 8 weeks
the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale
Time frame: 8 weeks
Pain Severity
Time frame: 8 weeks
Serum biomarkers level in (ng/mL)
Time frame: 8 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 9 Mar 2023.
- Derived from this study: PubMed 37583905Bakry HM, Mansour NO, ElKhodary TR, Soliman MM. Efficacy of metformin in prevention of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2023 Jul 31;14:1181312. doi: 10.3389/fphar.2023.1181312. eCollection 2023.
Related trials for Peripheral Neuropathy
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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 Metformin in people with Peripheral Neuropathy and Breast Cancer, run by Mansoura 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 4 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 9 Mar 2023. 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?
The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351021, which also lists 1 linked publication.
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 9 Mar 2023.