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

Mendel AI

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Oncology Pain; Chemotherapy-induced Peripheral Neuropathy

Treatments: Drug: Venlafaxine; Drug: Memantine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04737967

CIPN101

Details and patient eligibility

About

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)

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Venlafaxine Treated Arm

Experimental group

Treatment:

Drug: Venlafaxine

Memantine Treated Arm

Experimental group

Treatment:

Drug: Memantine