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The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

ConditionNeuropathy;Peripheral
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University

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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Children < 18 years old.

Prior exposure to neurotoxic chemotherapy (Oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH) for at least 6 months prior the study treatment.

Evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes, brain tumor, brain trauma).

Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo tablets

    Drug

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

  • Ketotifen Oral Tablet

    Drug

    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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: placeboPlacebo comparator 1 intervention
Group B: ketotifen oral tabletsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

variation in 12-item neurotoxicity questionnaire (Ntx-12) total score

the Ntx-12 questionnaire is comprised of 12 statements intended to measure the severity and impact of peripheral sensory neuropathy on patients' lives. Patients will be instructed to complete the Arabic version of the Ntx-12 and choose the number corresponding to how true each statement was for them using a likert-type scale, with 0 indicating not at all; 1, a little bit; 2, somewhat; 3, quite a bit; and 4, very much

Time frame
6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days)
2

variation in pain rating scale score

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.

Time frame
6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days)
3

the percentage of patients with peripheral sensory neuropathy grade ≥ 2

Grading according to National Cancer Institute Common Terminology. there are 5 grades; Grade (1) is asymptomatic may be accompanied by loss of tendon reflex or paresthesia. Grade (2) is moderate symptoms which limit instrumental activities of daily life Grade (3) is severe symptoms which limit self-care activates of daily life. Grade (4) is life threatening consequences or urgent intervention indicated. Grade (5) is death. Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017)

Time frame
6 months

Secondary outcomes

1

changes in serum levels of the measured biological marker Serum IL-6

as a marker of inflammation

Time frame
6 months (after 12 cycles and the cycle is every 15 days)
2

changes in serum levels of the measured biological marker Serum SOD

as a biomarker of oxidative stress

Time frame
6 months(after 12 cycles and the cycle is every 15 days)
3

changes in serum levels of the measured biological marker Serum neurotensin

biomarker for neuropathy

Time frame
6 months ( after 12 cycles and the cycle is every 15 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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