The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-10-01

Brief Summary

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This is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University.

All procedure will be done in Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine.

The first arm (Venlafaxine group) will receive Venlafaxine extended release (37.5 mg) tablets (Zimmerman et al., 2016).

The second arm (Memantine group) will receive memantine 10 mg once daily (Morel et al., 2016)

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Detailed Description

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Conditions

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Oncology Pain Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Venlafaxine Treated Arm

Group Type EXPERIMENTAL

Venlafaxine

Intervention Type DRUG

Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)

Memantine Treated Arm

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

Patients will receive memantine (10 mg) once daily (Morel et al., 2016)

Interventions

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Venlafaxine

Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)

Intervention Type DRUG

Memantine

Patients will receive memantine (10 mg) once daily (Morel et al., 2016)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. All patients, 18 years of age or older, with a cancer treated with Paclitaxel
2. Patients must have a life expectancy of at least 24 weeks.
3. Patients must sign an informed consent.
4. Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.
5. Patient matching high risk on the CIPN risk stratification scoring system

Exclusion Criteria

1. Patients with symptomatic brain metastases.
2. Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.
3. Patients may receive no other concurrent complementary medicines during this study.
4. Patients with neuropathy induced diabetes.
5. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No