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The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

NCT05624138 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-05-11

No results posted yet for this study

Summary

The aim of current study is to evaluate the possible protective role of Ketotifen against oxaliplatin-induced peripheral sensory neuropathy in patient with stage III colorectal cancer.

This study will be a randomized placebo controlled parallel study.64 patients with colorectal cancer will be randomized to 2 groups:

Group I (control group; n=32) which will receive 12 cycles of modified FOLFOX-6 regimen plus placebo tablets twice daily.

Group II (ketotifen group; n=32) which will receive modified FOLFOX-6 regimen in addition to ketotifen 2 mg daily

Blood sample collection and biochemical assessment:

* Serum IL-6 as a marker of inflammation.
* Serum superoxide dismutase (SOD) as a biomarker of oxidative stress.
* Serum neurotensin as a biomarker for neuropathy.

Assessment of oxaliplatin induced peripheral sensory neuropathy will be done through:

* The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy at baseline and by the end of every two oxaliplatin cycles.
* The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group "FACT/GOG-Ntx-12" at baseline and by the end of every two oxaliplatin cycles.
* The assessment of the severity of neuropathic pain through brief pain inventory short form "BPI-SF" worst item. Severity of neuropathic pain will be assessed at baseline and by the end of every two oxaliplatin cycles.

Conditions

  • Neuropathy;Peripheral

Interventions

DRUG

Placebo tablets

12 cycles of modified FOLFOX-6 regimen (Oxaliplatin, Fluorouracil, calcium leucovorin) with 2 mg placebo tablets

DRUG

Ketotifen Oral Tablet

ketotifen is a potent anti histaminic drug that may prevent oxaliplatin induced peripheral neuropathy and mucositis and will be administered 2 mg daily along with the 12 cycles of modified Folfox-6 regimen

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2024-04-04
Completion
2025-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05624138 on ClinicalTrials.gov