Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05510856
Collaborator
(none)
90
3
24

Study Details

Study Description

Brief Summary

This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: Duloxetine
  • Other: Gabapentin
  • Other: Lacosamide
Phase 4

Detailed Description

This is a randomized, double-blind parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer.

This study will be done on 90 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard CAPEOX regimen who will divided into 3 groups:

Group 1: 30 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 8 cycles (up to 6 months).

Group 2: 30 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 8 cycles (up to 6 months).

Group 3: 30 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 8 cycles (up to 6 months).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
double blind
Primary Purpose:
Prevention
Official Title:
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Duloxetine

group 1

Other: Duloxetine
Duloxetine 30mg / day for 8 cycles (up to 6 months)

Experimental: Gabapentin

group 2

Other: Gabapentin
Gabapentin 300 mg / day for 8 cycles (up to 6 months)

Experimental: Lacosamide

group 3

Other: Lacosamide
Lacosamide 50 mg / day for 8 cycles (up to 6 months)

Outcome Measures

Primary Outcome Measures

  1. Brief Pain Inventory-Short Form [every 2 weeks]

    questionnaire

  2. 12-item neurotoxicity questionnaire [every 2 weeks]

    questionnaire

  3. EORTC Core Quality of Life questionnaire [up to 6 months]

    questionnaire

Secondary Outcome Measures

  1. Neurofilament light chain (NfL) [up to 6 months]

    biological biomarker

  2. Nuclear factor- kappa B (NF- κB) [up to 6 months]

    biological biomarker

  3. Neurotensin (NT) [up to 6 months]

    biological biomarker

  4. Malondialdehyde (MDA) [up to 6 months]

    biological biomarker

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Adults ≥ 18 years old male and female patients. B) Patients with gastrointestinal cancer receiving oxaliplatin chemotherapy
Exclusion Criteria:
    1. Preexisting neuropathic or brain disorders. B) Previous use of chemotherapeutic agents including taxanes, platinum, vinca alkaloids, and bortezomib.
  1. Concomitant use of drugs reported to have neuroprotective role and analgesics.

  2. Patients with diabetes, uncontrolled hypertension, congestive heart failure, drug addiction and patients who were receiving tamoxifen.

  3. Patients with abnormal renal function tests (serum creatinine ≤ 30 ml/min) or liver function tests (≥ 3 times the upper normal range).

  4. Participants with a documented medical history of neuropathy. G) Concomitant use of other antidepressants, anticonvulsants, high-dose vitamin supplements or drugs known to influence serotonin levels.

  5. Pregnancy and lactating women. I) Uncooperative patients and patients who have psychological problems or on antipsychotic medications.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sally Said Mohamed Tantawy, Clinical Pharmacist, Tanta University
ClinicalTrials.gov Identifier:
NCT05510856
Other Study ID Numbers:
  • oxaliplatin induced neuropathy
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sally Said Mohamed Tantawy, Clinical Pharmacist, Tanta University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022