Chemotherapy Induced Peripheral NeuropathyPhase 3NCT05680870
The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients
A Phase 3 study testing Omeprazole in people with Chemotherapy Induced Peripheral Neuropathy, run by Aya Mohamed Sadek Elsaid at 1 site in Egypt.
Trial summary
Oxaliplatin(OXA) chemotherapy protocols are used in treatment of cancers like colorectal (CRC) and pancreatic cancer. OXA causes peripheral neuropathy which is considered treatment limiting factor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy
- What is being tested?
- Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 12 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently diagnose cases with colorectal (CRC)and pancreatic cancers (males and females) ≥ 18 years old, and ≤ 65 years old.
- Patients who will scheduled to receive modified FOLFOX-4,6,7 (OXA, Leucovorin, and 5-fluorouracil) or mFOLFIRINOX (OXA, irinotecan,leucovorin, and 5-Fluorouracil) for 12 cycles.
- Patients with performance status 0-2 according to Eastern Cooperative Oncology Group (ECOG) Score.
Who cannot join
- Evidence of pre-existing peripheral neuropathy resulting from another reason (documented patients with brain tumor, brain trauma, seizures or any other neuropathic disorder).
- CRC patients receiving protocols containing capecitabine.
- Diabetic patients.
- Documented Patients with lupus (SLE), or any other autoimmune disease.
- Documented Patients with osteoporosis or fractures.
- Prior exposure to neurotoxic chemotherapy for at least 6 months prior to the study.
Show all 12Show fewer
- Concomitant use of other neuroprotective medications (gabapentin, lamotrigine, phenytoin, tricyclic antidepressants, etc.,).
- Patients taking medications that omeprazole can interact with or affect their metabolism, such as (digoxin, ketoconazole, methotrexate, clopidogrel, marevan, etc.,).
- Pregnant and breastfeeding women.
- Patients with abnormal renal function (S.cr > 1.5 mg/dl or crcl < 45 ml/min).
- Patients with liver diseases (serum bilirubin > 1.5 mg/dl / Alanine transaminase, Aspartate transaminase > 2-4 ULN).
- Smokers or documented patients with condition associated with oxidative stress.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Patients With Cancer Treated With Oxaliplatin-fluorouracil Chemotherapy Protocols
Oxaliplatin(OXA) chemotherapy protocols are used in treatment of cancers like colorectal (CRC) and pancreatic cancer. OXA causes peripheral neuropathy which is considered treatment limiting factor. In recent studies, it shows that omeprazole(OME) has antioxidant effect and can inhibit organic cation transporter 2 (OCT2) in kidney. So OME can protect against peripheral neuropathy induced by OXA through oxidative stress . Also OME activates extracellular-signal-regulated kinase(ERK) / mitogen activated protein kinase ( MAPK) pathway, so improves demyelinating symptoms.
Read the detailed description
Randomized controlled parallel study
Forty-six patients with pancreatic cancer or CRC who receive OXA 85mg/m2 in their protocols scheduled as a cycle every two consecutive weeks for 6 months to receive 12 cycles. Patients will be recruited from Clinical Oncology and Nuclear Medicine Department, Mansoura University Hospital, Mansoura, Egypt. The patients will be randomized using sealed envelope method into two groups:
According to the results of previous studies, the total number of subjects required detecting the effect of neuro-protective drugs in patients received chemotherapy with 5% significance and 80% power and attrition rate equal to 15% was 41 . In this context, during the current study, a total sample size 42 patients in both arms will be sufficient to provide a good power to detect the effect. Assuming that the attrition rate will be 10% the initial sample size will be 46 patients in both arms.
Assessment of patient adherence and evaluation of drug safety The medication will be provided on biweekly intervals and the participants adherence will be assessed through counting the pills and by medications refilling rate. Participants will also followed-up by telephone calls and through direct meetings during chemotherapy cycles to assess their adherence and report any drugs related adverse effects using adverse drug reactions reporting form the adverse effects will be also collected through patients' laboratory data and patient sheet. The patients will be asked about any adverse effects related to study medication. Patients will be considered non-adherent and excluded from the study if consumed less than 90% of study medication at any month of the study duration.
Statistical analysis - Statistical analysis will be done by the statistical software package version 25 . Data will be tested for normality using Kolmogorov-Smirnov and Shapiro wilk tests. Normally distributed data will be analyzed using paired and un-paired t-test. Non normally distributed data will be compared using Mann-Whitney U test. Also, Mann-Whitney U test will be used to compare non-parametric data between the two arms including the neuropathy grading and the Neurotoxicity-12(NTX-12) total scores. Categorical data will be computed by Chi-square test. - Fisher exact test will be used to analyze the reported adverse effects. - Correlation between variables will be analyzed by Pearson or spearman correlation what appropriate. - The significance level was set at p<0.05.
- Being tested
- Omeprazole
- Keywords
- Peripheral neuropathy, Colorectal cancer, Pancreatic cancer
- Medical subject headings
- Peripheral Nervous System Diseases, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Omez
Omeprazole 40 mg 3 times daily for 5 days ..to start 2 days before chemotherapy cycles
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control grp will not receive omeprazole . They will receive chemotherapy protocols only |
| Intervention group | Experimental | Intervention group will receive omeprazole plus chemotherapy protocols Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute peripheral neuropathy
the percentage of patients with acute peripheral sensory neuropathy grade ≥ 2 and the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and pain rating scale score
Measured: After the first intervention by 2 weeks of the first chemotherapy cycle ( each cycle is two days every two weeks), and through the study average for six months
Chronic peripheral neuropathy
Percentage of patients who have developed chronic peripheral neuropathy grade ≥ 2 after the end of 12 cycles and the variation of both NTX-12 total score and pain rating scale
Measured: After the end of 12 chemotherapy cycles ( after six months of interventions)
Secondary outcomes (3)
Malonaldehyde
Changes in malonaldehyde level
Measured: After 3 months of treatment
Neurotensin
Changes in neurotensin level
Measured: After 3 months of treatment
OCT
Changes in OCT level
Measured: After 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Feb 2023
- Primary completion5 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- 46 participants will be classified into 2 arms : intervention arm will receive omeprazole plus chemotherapy Control arm will receive chemotherapy only
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Mohamed Sadek Elsaid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Mohamed Sadek Elsaid, Tanta University
- Investigators
- Sahar K Hegazy, Professor, Study director, Professor of clinical pharmacy , faculty of pharmacy, Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680870
- Sponsor's protocol ID
- MS.22.12.2244.R1
- Status last verified
- Sep 2025
- First submitted
- 28 Dec 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Patients With Cancer Treated With Oxaliplatin-fluorouracil Chemotherapy Protocols
- ClinicalTrials.gov ID
- NCT05680870
- Acronym / sponsor ID
- MS.22.12.2244.R1
- Keywords
- Peripheral neuropathy, Colorectal cancer, Pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Aya Mohamed Sadek ElsaidUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 11 Jan 2023 (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.
Oxaliplatin(OXA) chemotherapy protocols are used in treatment of cancers like colorectal (CRC) and pancreatic cancer. OXA causes peripheral neuropathy which is considered treatment limiting factor. In recent studies, it shows that omeprazole(OME) has antioxidant effect and can inhibit organic cation transporter 2 (OCT2) in kidney. So OME can protect against peripheral neuropathy induced by OXA through oxidative stress . Also OME activates extracellular-signal-regulated kinase(ERK) / mitogen activated protein kinase ( MAPK) pathway, so improves demyelinating symptoms.
Detailed description
Randomized controlled parallel study
Forty-six patients with pancreatic cancer or CRC who receive OXA 85mg/m2 in their protocols scheduled as a cycle every two consecutive weeks for 6 months to receive 12 cycles. Patients will be recruited from Clinical Oncology and Nuclear Medicine Department, Mansoura University Hospital, Mansoura, Egypt. The patients will be randomized using sealed envelope method into two groups:
According to the results of previous studies, the total number of subjects required detecting the effect of neuro-protective drugs in patients received chemotherapy with 5% significance and 80% power and attrition rate equal to 15% was 41 . In this context, during the current study, a total sample size 42 patients in both arms will be sufficient to provide a good power to detect the effect. Assuming that the attrition rate will be 10% the initial sample size will be 46 patients in both arms.
Assessment of patient adherence and evaluation of drug safety The medication will be provided on biweekly intervals and the participants adherence will be assessed through counting the pills and by medications refilling rate. Participants will also followed-up by telephone calls and through direct meetings during chemotherapy cycles to assess their adherence and report any drugs related adverse effects using adverse drug reactions reporting form the adverse effects will be also collected through patients' laboratory data and patient sheet. The patients will be asked about any adverse effects related to study medication. Patients will be considered non-adherent and excluded from the study if consumed less than 90% of study medication at any month of the study duration.
Statistical analysis - Statistical analysis will be done by the statistical software package version 25 . Data will be tested for normality using Kolmogorov-Smirnov and Shapiro wilk tests. Normally distributed data will be analyzed using paired and un-paired t-test. Non normally distributed data will be compared using Mann-Whitney U test. Also, Mann-Whitney U test will be used to compare non-parametric data between the two arms including the neuropathy grading and the Neurotoxicity-12(NTX-12) total scores. Categorical data will be computed by Chi-square test. - Fisher exact test will be used to analyze the reported adverse effects. - Correlation between variables will be analyzed by Pearson or spearman correlation what appropriate. - The significance level was set at p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 46 participants will be classified into 2 arms : intervention arm will receive omeprazole plus chemotherapy Control arm will receive chemotherapy only
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control grp will not receive omeprazole . They will receive chemotherapy protocols only |
| Intervention group | Experimental | Drug: OmeprazoleIntervention group will receive omeprazole plus chemotherapy protocols |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recently diagnose cases with colorectal (CRC)and pancreatic cancers (males and females) ≥ 18 years old, and ≤ 65 years old.
- Patients who will scheduled to receive modified FOLFOX-4,6,7 (OXA, Leucovorin, and 5-fluorouracil) or mFOLFIRINOX (OXA, irinotecan,leucovorin, and 5-Fluorouracil) for 12 cycles.
- Patients with performance status 0-2 according to Eastern Cooperative Oncology Group (ECOG) Score.
Key exclusion criteria (12 listed)
- Evidence of pre-existing peripheral neuropathy resulting from another reason (documented patients with brain tumor, brain trauma, seizures or any other neuropathic disorder).
- CRC patients receiving protocols containing capecitabine.
- Diabetic patients.
- Documented Patients with lupus (SLE), or any other autoimmune disease.
- Documented Patients with osteoporosis or fractures.
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 |
|---|---|---|
| OmeprazoleAlso: OmezOmeprazole 40 mg 3 times daily for 5 days ..to start 2 days before chemotherapy cycles | Drug | Intervention group |
Primary outcome
Acute peripheral neuropathy
Time frame: After the first intervention by 2 weeks of the first chemotherapy cycle ( each cycle is two days every two weeks), and through the study average for six months
the percentage of patients with acute peripheral sensory neuropathy grade ≥ 2 and the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and pain rating scale score
Chronic peripheral neuropathy
Time frame: After the end of 12 chemotherapy cycles ( after six months of interventions)
Percentage of patients who have developed chronic peripheral neuropathy grade ≥ 2 after the end of 12 cycles and the variation of both NTX-12 total score and pain rating scale
3 secondary outcomes
Malonaldehyde
Time frame: After 3 months of treatment
Neurotensin
Time frame: After 3 months of treatment
OCT
Time frame: After 3 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy Induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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. This study is not recruiting at the moment.
Sahar K Hegazy, Professor study director
Professor of clinical pharmacy , faculty of pharmacy, Tanta university
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 Omeprazole in people with Chemotherapy Induced Peripheral Neuropathy, run by Aya Mohamed Sadek Elsaid 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 9 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute peripheral neuropathy (time frame: After the first intervention by 2 weeks of the first chemotherapy cycle ( each cycle is two days every two weeks), and through the study average for six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.