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Trial Title:
The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy
NCT ID:
NCT05624138
Condition:
Neuropathy;Peripheral
Conditions: Official terms:
Peripheral Nervous System Diseases
Leucovorin
Ketotifen
Oxaliplatin
Fluorouracil
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
- Study design This study will be a Randomized placebo controlled parallel study Group
one (Placebo group or code A; n=32)
Patients will receive 12 cycles of modified FOLFOX-6 regiment plus placebo tablets daily
throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every
2 weeks and will be as follows:
Day 1: Oxaliplatin 85 mg/m2 intravenous infusion in 250-500 mL 5% dextrose solution and
leucovorin 400 mg/m2 intravenous infusion in 5% dextrose solution both were given over
120 minutes at the same time in separate bags using a Y-line access, followed by
5-fluorouracil 400 mg/m2 intravenous bolus given over 2-4 minutes, followed by
5-fluorouracil 2400 mg/m2 intravenous infusion in 500 mL 5% dextrose solution as a
46-hour infusion.
Group two (Ketotifen group or code B; n=32) Patients will receive the same chemotherapy
regimen as group one in addition to oral ketotifen 2 mg daily throughout the twelve
chemotherapy cycles.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Placebo tablets
Description:
12 cycles of modified FOLFOX-6 regimen (Oxaliplatin, Fluorouracil, calcium leucovorin)
with 2 mg placebo tablets
Arm group label:
placebo
Other name:
Oxaliplatin, Fluorouracil, calcium leucovorin
Intervention type:
Drug
Intervention name:
Ketotifen Oral Tablet
Description:
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
Arm group label:
ketotifen oral tablets
Other name:
ketotifen
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.
Detailed description:
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.
- Study design
This study will be a Randomized placebo controlled parallel study. Sixty four patients
with stage III colorectal cancer will be scheduled to receive 12 cycles of modified
FOLFOX-6 (folinic acid, flurouracil and oxaliplatin). Patients will be recruited from the
Oncology Department, Tanta University Hospital, Tanta, Egypt. Staging will be done
according to the American Joint Committee on Cancer 7th edition staging (Edge and
Compton, 2010). At admission, patients will be randomized through sealed envelopes method
with assignment codes (A and B) into two groups to receive either Placebo or ketotifen in
addition to the chemotherapeutic regimen:
Group one (Placebo group or code A; n=32)
Patients will receive 12 cycles of modified FOLFOX-6 regiment plus placebo tablets daily
throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every
2 weeks and will be as follows:
Day 1: Oxaliplatin 85 mg/m2 intravenous infusion in 250-500 mL 5% dextrose solution and
leucovorin 400 mg/m2 intravenous infusion in 5% dextrose solution both were given over
120 minutes at the same time in separate bags using a Y-line access, followed by
5-fluorouracil 400 mg/m2 intravenous bolus given over 2-4 minutes, followed by
5-fluorouracil 2400 mg/m2 intravenous infusion in 500 mL 5% dextrose solution as a
46-hour infusion.
Group two (Ketotifen group or code B; n=32) Patients will receive the same chemotherapy
regimen as group one in addition to oral ketotifen 2 mg daily throughout the twelve
chemotherapy cycles.
Intravenous 5-HT3 antagonist plus pantoprazole will be administered to all participants
before each cycle as prophylactic therapy against chemotherapy induced nausea, vomiting
and mucositis.
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.
Criteria for 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 (absolute neutrophilic count ≥ 1.5 × 109/L,
platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).
- Patients with adequate renal function (serum creatinine < 1.5 mg/dl or creatinine
clearance (ClCr) ˃ 45 mL/min).
- Patients with adequate liver function (serum bilirubin < 1.5 mg/dl).
- Patients with performance status 0-1 according to Eastern Cooperative Oncology Group
(ECOG) score.
Exclusion Criteria:
- 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.
- History of known allergy to oxaliplatin or other platinum agents.
- Patients with other inflammatory or stressful conditions.
- Patients with glaucoma, cataract, other chronic eye disease, seizure, diabetes,
heart diseases, low blood pressure, dizziness, vertigo, ménière's disease and CNS
disorders.
- Concomitant use of multivitamins (vitamins E, C, A), tricyclic antidepressants,
other neuro-protective medications (gabapentin, lamotrigine, carbamazepine and
phenytoin, etc...).
- Patients on amifampridine, bupropion and donepezil.
- Concurrent active cancer originating from a primary site other than colon or rectum.
- Pregnant and breastfeeding women.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology department Tanta university
Address:
City:
Tanta
Zip:
31511
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
salma S wahby
Phone:
01111103067
Email:
salmawahby135@outlook.com
Start date:
November 9, 2022
Completion date:
November 2024
Lead sponsor:
Agency:
Tanta University
Agency class:
Other
Source:
Tanta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05624138