Preventive Approach Using Venlafaxine

NCT05875610 | Unknown Phase 4 FDA Drug

• 1 other identifier: 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Keywords

Peripheral neuropathy; Taxanes; oxaliplatin; Chemotherapy; Venlafaxine

Outcome Measures

Primary Outcomes (1)

• The incidence of grade II or more peripheral neuropathy

  Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)

  4 months

Secondary Outcomes (2)

• The EORTC QLQ-CIPN20 subscales

  4 months

• Pain Severity

  4 months

Study Arms (2)

Venlafaxine Arm

EXPERIMENTAL

Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.

Drug: Venlafaxine 75 MG

Gabapentin Arm

ACTIVE COMPARATOR

Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.

Drug: Gabapentin 400 mg

Interventions

Venlafaxine 75 MG DRUG

Venlafaxine 75 mg extended release capsules for a 7-days duration

Venlafaxine Arm

Gabapentin 400 mg DRUG

Gabapentin 400 mg capsules

Gabapentin Arm

Eligibility Criteria

• Age: 24 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>24 years of age, men or women to lower risk of suicidal tendency.
• Patients with histologically proven cancer
• Patients receiving oxaliplatin or taxanes-based regimen
• WHO performance status of 0-2
• serum AST or ALT no higher than two times the upper limit of normal
• serum creatinine level less than 2 mg/dL
• platelet count of at least 100,000/mm3
• absolute neutrophil count of at least to 1.0 G/L
• Female patients, those with a negative urine pregnancy test.

You may not qualify if:

• Patients with brain or leptomeningeal metastasis.
• Patients with previous platinum-based chemotherapy
• Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions.
• Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.

Sponsors & Collaborators

• Mit Ghamr Oncology Center: lead

Study Sites (1)

Mit Ghamr Oncology Center

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Venlafaxine Hydrochloride; Gabapentin

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Mahmoud Mahrous

CONTACT

+201007778360; mahmodmahros71@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical pharmacy department

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

EG (1)