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Evaluation of the effect of amantadine in the prevention of Paclitaxel-Induced peripheral neuropathy in breast cancer patients

NCT ID NCT07889115

Sponsor: Al-Azhar University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time

Summary

This randomized, controlled, open-label trial will evaluate the efficacy and safety of amantadine, an NMDA receptor antagonist with antioxidant and anti-inflammatory properties, in preventing paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients receiving weekly paclitaxel.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Inclusion criteria * Adult patients (\>18 years old). * Patients with confirmed diagnosis of non-metastatic breast cancer planned to receive weekly adjuvant/neo-adjuvant paclitaxel. * Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion criteria * Patients with pre-existing neuropathic conditions. * Patients with diabetes mellitus. * Patients with a history of seizure disorder. * Patients with renal impairment (creatinine clearance less than 60 ml/min), or hepatic impairment (defined as ALT an AST \> 3 times upper limits of normal) * Patients with inadequate bone marrow functions (defined as absolute neutrophilic count less than 1,500/mm³ or platelets count less than 100,000/mm³). * Concomitant use of vitamin B1, B6, B9, or B12. * Patients receiving medications that possibly induce peripheral neuropathy including amiodarone, colchicine, metronidazole, antimycobacterials, and nucleoside reverse transcriptase inhibitors, and phenytoin (Jones et al., 2020). * Patients receiving gabapentinoids, antidepressants, or opioids. * Pregnancy or lactation. * History of hypersensitivity to amantadine * Concurrent use of anticholinergic drugs (e.g., antihistamines, tricyclic antidepressants, antipsychotics, antispasmodics, or antiparkinsonian agents) within 2 weeks before enrollment, except for short-term use of antiemetics prescribed as part of standard chemotherapy supportive care (e.g., prochlorperazine, promethazine). Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm chemotherapy-induced neuropathy peripheral nervous system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Peripheral neuropathy due to chemotherapy Vas score

How to take part

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  1. The official record

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