Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
Cancer, chemotherapy-induced peripheral neuropathy, metformin, neuropathy
Brief 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. 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.
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
Interventions
DRUGMetformin
Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration
DRUGPlacebo
Participants in the placebo group will be administered metformin free tablet as placebo twice daily
Sponsors
German University in Cairo
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of grade 2-4 neurotoxicity in both arms | 3 months | Measured by NCI-CTCAE system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in biological markers in both arms. | 3 months | Measurement of Nerve growth factor (NGF) |
| Percentage of Qulaity of Life (QOL) deterioration in both arms | 3 months | 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. |
| Percentage of other treatment related common adverse events in both arms. | 3 months | Graded using NCI-CTCAE system |
Countries
Egypt
Contacts
Primary ContactSara A. Mosa, Bsc
Outcome results
None listed