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Chemotherapy-induced Peripheral NeuropathyPhase 2NCT04780854

Drug Repurposing for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)

A Phase 2 study testing Metformin in people with Chemotherapy-induced Peripheral Neuropathy, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chemotherapy cause many adverse events including induction of peripheral neuropathy. Metformin, the AMPK activator, was found to have protective effect against chemotherapy induced peripheral neuropathy in mouse model and in clinical trials as well. Read more about this study

Who is it for?
Ages 18 to 75 years
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
68 participants
Where
1 siteEgypt
Study dates
3 Nov 2020to Jul 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age (18-75) male and female patients
  • Scheduled to be treated with single agent Paclitaxel
  • Performance status according to Eastern Cooperative oncology group (ECOG) < 2.
  • Patients who are willing and able to review and provide written consent, patients who can read the questionnaires

Who cannot join

  • Previous exposure to chemotherapy drugs that cause neuropathy, patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
  • Patients with impaired liver functions or kidney functions.
  • Patients with a history of any serious adverse events or interaction or hypersensitivity to Metformin.
  • Pregnant or lactating females.
  • Patients who are using metformin for any other cause.
  • Patients with sensory or motor neuropathy of any grade prior to enrollment.

Trial locations and contacts

1 site in 1 country.

Sara A. Mosa, Bsc contact

+201008662223

sara.araby96@gmail.com

Egypt1 site, 1 recruiting

  • Cairo University

    Cairo

    Loay Kassem

    Loay Kassem

    Recruiting

Other trials in Egypt

About this study

Chemotherapy cause many adverse events including induction of peripheral neuropathy. Metformin, the AMPK activator, was found to have protective effect against chemotherapy induced peripheral neuropathy in mouse model and in clinical trials as well. There are different hypothesized mechanisms through which metformin does the protective effect. Such as enhancing mitochondrial activity, reduction of ROS and nitric oxide and activation of AMPK.

Read the detailed description

Chemotherapy can cause a variety of side effects. One of the most common side effects is Chemotherapy induced peripheral neuropathy (CIPN), it commonly caused by Paclitaxel chemotherapy which is usually used in the treatment of breast cancer. Metformin which is known as a safe anti-diabetic drug, was found to have a protective effect on neurons. It gave positive results in chemotherapy induced peripheral neuropathy in mouse models and in some clinical trials

Being tested
Metformin, Placebo
Keywords
Cancer, chemotherapy-induced peripheral neuropathy, metformin, neuropathy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called N,N-dimethylbiguanide, Cidophage

    Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration

  • PlaceboDrug

    Also called inactive pill

    Participants in the placebo group will be administered metformin free tablet as placebo twice daily

Study groups in NCT04780854
Study groupRoleWhat they receive
Metformin groupActive comparator1 gm metformin tablet administered twice daily for 3 months
Receives: Drug: Metformin
Metformin-freePlacebo comparator1 placebo tablet administered twice daily for 3 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of grade 2-4 neurotoxicity in both arms

    Measured by NCI-CTCAE system

    Measured: 3 months

Secondary outcomes (4)

  1. Difference in biological markers in both arms.

    Measurement of Nerve growth factor (NGF)

    Measured: 3 months

  2. Difference in biological markers in both arms.

    Measurement of Malondialdehyde (MDA)

    Measured: 3 months

  3. Percentage of Qulaity of Life (QOL) deterioration in both arms

    Measured using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) questionnaire. The higher the score, the better the quality of life.

    Measured: 3 months

  4. Percentage of other treatment related common adverse events in both arms.

    Graded using NCI-CTCAE system

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start3 Nov 2020
  3. Primary completionMay 2022 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

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
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04780854
Sponsor's protocol ID
S-5-2020
Status last verified
Jul 2021
First submitted
2 Nov 2020
Last updated
28 Jul 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gaballah A, Shafik A, Elhusseiny K, Ashraf M. Chemotherapy-Induced Peripheral Neuropathy in Egyptian Patients: Single Institution Retrospective Analysis. Asian Pac J Cancer Prev. 2018 Aug 24;19(8):2223-2227. doi: 10.22034/APJCP.2018.19.8.2223.

    PubMed 30139229

  • Mao-Ying QL, Kavelaars A, Krukowski K, Huo XJ, Zhou W, Price TJ, Cleeland C, Heijnen CJ. The anti-diabetic drug metformin protects against chemotherapy-induced peripheral neuropathy in a mouse model. PLoS One. 2014 Jun 23;9(6):e100701. doi: 10.1371/journal.pone.0100701. eCollection 2014.

    PubMed 24955774

  • Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.

    PubMed 24733808

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin in people with Chemotherapy-induced Peripheral Neuropathy, run by Cairo 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 6 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: status not confirmed, as of the sponsor's last update on 28 Jul 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sara A. Mosa, Bsc (+201008662223, sara.araby96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of grade 2-4 neurotoxicity in both arms (time frame: 3 months). 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 NCT04780854, which also lists 3 linked publications.

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 28 Jul 2021.

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