Neuropathy;PeripheralPhase 3NCT05624138
The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy
A Phase 3 study testing Ketotifen Oral Tablet in people with Neuropathy;Peripheral, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy;Peripheral
- What is being tested?
- Ketotifen Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2022to Jun 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Oncology department Tanta university
Tanta, Other, 31511
salma S wahby, 01111103067, salmawahby135@outlook.com
About this study
Official title: The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
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:
Read more
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.
Read the 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.
- Conditions
- Neuropathy;Peripheral
- Being tested
- Placebo tablets, Ketotifen Oral Tablet
- Medical subject headings
- Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo tabletsDrug
Also called Oxaliplatin, Fluorouracil, calcium leucovorin
12 cycles of modified FOLFOX-6 regimen (Oxaliplatin, Fluorouracil, calcium leucovorin) with 2 mg placebo tablets
Ketotifen Oral TabletDrug
Also called ketotifen
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
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Group I Placebo group n=32 Patients will receive 12 cycles of modified FOLFOX-6 regiment plus placebo tablets 2mg daily throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every 2 weeks and will be as follows:
Day 1 and Day 15: 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. Receives: Drug: Placebo tablets |
| ketotifen oral tablets | Active comparator | Group II ketotifen group n=32 Patients will receive 12 cycles of modified FOLFOX-6 regiment plus ketotifen tablets 2mg daily throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every 2 weeks and will be as follows:
Day 1 and Day 15 : 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 Receives: Drug: Ketotifen Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days)
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.
Measured: 6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days)
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)
Measured: 6 months
Secondary outcomes (3)
changes in serum levels of the measured biological marker Serum IL-6
as a marker of inflammation
Measured: 6 months (after 12 cycles and the cycle is every 15 days)
changes in serum levels of the measured biological marker Serum SOD
as a biomarker of oxidative stress
Measured: 6 months(after 12 cycles and the cycle is every 15 days)
changes in serum levels of the measured biological marker Serum neurotensin
biomarker for neuropathy
Measured: 6 months ( after 12 cycles and the cycle is every 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start9 Nov 2022
- Primary completion4 Apr 2024
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathy;PeripheralStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Samah Sayed Wahby, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624138
- Sponsor's protocol ID
- ketotifen in neuropathy
- Status last verified
- May 2025
- First submitted
- 8 Nov 2022
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wahby SS, Mostafa TM, El-Din MAA, Elberri EI. Ketotifen for Preventing Oxaliplatin-Induced Neuropathy in Stage III Colorectal Cancer: a Randomized Controlled Trial. J Gastrointest Cancer. 2026 May 7;57(1):106. doi: 10.1007/s12029-026-01456-4.
PubMed 42096115
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05624138
- Acronym / sponsor ID
- ketotifen in neuropathy
- Conditions
- Neuropathy;Peripheral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo tabletsGroup I Placebo group n=32 Patients will receive 12 cycles of modified FOLFOX-6 regiment plus placebo tablets 2mg daily throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every 2 weeks and will be as follows: Day 1 and Day 15: 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. |
| ketotifen oral tablets | Active comparator | Drug: Ketotifen Oral TabletGroup II ketotifen group n=32 Patients will receive 12 cycles of modified FOLFOX-6 regiment plus ketotifen tablets 2mg daily throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every 2 weeks and will be as follows: Day 1 and Day 15 : 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo tabletsAlso: Oxaliplatin, Fluorouracil, calcium leucovorin12 cycles of modified FOLFOX-6 regimen (Oxaliplatin, Fluorouracil, calcium leucovorin) with 2 mg placebo tablets | Drug | placebo |
| Ketotifen Oral TabletAlso: ketotifenketotifen 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 | Drug | ketotifen oral tablets |
Primary outcome
variation in 12-item neurotoxicity questionnaire (Ntx-12) total score
Time frame: 6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days)
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
variation in pain rating scale score
Time frame: 6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days)
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.
the percentage of patients with peripheral sensory neuropathy grade ≥ 2
Time frame: 6 months
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)
3 secondary outcomes
changes in serum levels of the measured biological marker Serum IL-6
Time frame: 6 months (after 12 cycles and the cycle is every 15 days)
changes in serum levels of the measured biological marker Serum SOD
Time frame: 6 months(after 12 cycles and the cycle is every 15 days)
changes in serum levels of the measured biological marker Serum neurotensin
Time frame: 6 months ( after 12 cycles and the cycle is every 15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 42096115Wahby SS, Mostafa TM, El-Din MAA, Elberri EI. Ketotifen for Preventing Oxaliplatin-Induced Neuropathy in Stage III Colorectal Cancer: a Randomized Controlled Trial. J Gastrointest Cancer. 2026 May 7;57(1):106. doi: 10.1007/s12029-026-01456-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketotifen Oral Tablet in people with Neuropathy;Peripheral, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact salma S wahby, Master (00201111103067, salmawahby135@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation in 12-item neurotoxicity questionnaire (Ntx-12) total score (time frame: 6 months (at baseline and after 2 oxaliplatin cycles( the cycle is every 15 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05624138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.