Ketotifen for Oxaliplatin-Induced Nerve Pain

The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

Recruiting Phase 3 Interventional Study
Neuropathy;Peripheral
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
64 (estimated)
Sponsor
Tanta University · Other
Who this trial is looking for

This trial is looking for patients with stage III colorectal cancer. Participants will receive an established chemotherapy treatment along with either a placebo or the drug ketotifen to see if it helps reduce nerve pain caused by chemotherapy.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with stage III colorectal cancer.
  • I am scheduled to receive modified FOLFOX-6 chemotherapy.
  • I have good kidney function.
  • I have adequate liver function.
  • I have good blood counts.
  • I have a performance status score of 0-1.

You may not be able to join if

  • I am under 18 years old.
  • I have had prior neurotoxic chemotherapy within the last 6 months.
  • I have a history of peripheral neuropathy from other causes.
  • I have diabetes or other conditions that cause neuropathy.
  • I know I am allergic to oxaliplatin or other platinum drugs.
  • I have other chronic health conditions like heart disease or seizures.
  • I am taking certain neuro-protective medications.
  • I am currently pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients with histologically confirmed diagnosis of Stage III colorectal cancer. * Patients who will be scheduled to receive modified FOLFOX-6. * Patients with no contraindication to chemotherapy. * Males and females aged ≥ 18 years old. * Adequate baseline hematologic values …
Contacts

salma S wahby, Master

00201111103067

salmawahby135@outlook.com

CONTACT

Tarek M mostafa, Professor of clinical pharmacy

01154594035

tarek.mostafa@pharm.tanta.edu.eg

CONTACT