Peripheral NeuropathyPhase 1/2NCT02808624
L-carnosine Prophylactic Effect on Oxaliplatin Induced Peripheral Neuropathy in GIT Cancer Patients
A Phase 1/2 study testing L-CARNOSINE in people with Peripheral Neuropathy and Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And then neuropathy together with some oxidative… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Peripheral Neuropathy, Cancer
- What is being tested?
- L-CARNOSINE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients are eligible to be enrolled in this study, if they meet the following criteria
- Elderly males and females with age (˃18 and ˂60).
- Cancer patients treated with oxaliplatin for the first time (dose 85- 135mg/m2) administered every two to three weeks for 3 months.
Who cannot join
- Excluded from this study are the patients with the following Criteria:
- Suffering from diabetes mellitus.
- Suffering from peripheral neuropathy as a result of any other disease or drug.
- Suffering from severe renal impairment (CrCl ˂ 30 ml/min).
- Suffering from epilepsy.
- Taking vitamin B.
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- Who previously took Oxaliplatin or any other chemotherapeutic agent that causes peripheral neuropathy.
- Taking antidepressants or MAOI's.
- Taking NSAIDs, paracetamol, opiates or any other analgesics or pain killers.
- Pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Prophylactic Effect of Exogenous Antioxidant ''L-CARNOSINE'' on Oxaliplatin-induced Peripheral Neuropathy in Cancer Patients
This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And then neuropathy together with some oxidative stress markers will be assessed at the end of treatment duration (three months) .
Read the detailed description
Oxaliplatin causes peripheral neuropathy , L-CARNOSINE is supposed to prevent this side effect possibly by reducing oxidative stress and enhancing the growth of nerves.This study is intended to clarify the effect and mechanism of action of L-CARNOSINE in preventing Oxaliplatin induced peripheral neuropathy in cancer patients.
Blood samples will be collected from the patients before starting the chemotherapy and at the end of treatment duration (3 months) and then oxidative stress markers will be measured in these samples
- Conditions
- Peripheral Neuropathy, Cancer
- Being tested
- L-CARNOSINE
- Keywords
- Oxaliplatin, peripheral neuropathy, L-CARNOSINE
- Medical subject headings
- Peripheral Nervous System Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CARNOSINEDrug
Also called CARNOSINE
L-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | this arm will receive L-CARNOSINE PO (each patient will receive 1 tablet daily and each tablet contains 500 mg thus a total of 500 mg per day) together with their chemotherapy wich is oxaliplatin. Receives: Drug: L-CARNOSINE |
| Control group | No intervention | This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits.
The following markers will be measured by ELISA kits :
Nrf2 induced oxidative stress pathways (GSH) NF-KB anti-inflammatory pathway (TNF- alpha) pro-apoptic signals (caspase 3)
Measured: Three months
Secondary outcomes (1)
Assessment of tumor markers (CA,CEA) in blood.
Tumor Markers (CA,CEA) will be assessed at the end of treatment duration to make sure that L-CARNOSINE didn't interfere with the patients' response to chemotherapy.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Cairo 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University, Ain Shams University
- Responsible party
- Principal investigator, Rana Magdy, Misr International University
- Investigators
- Samira Saleh, Professor, Study director, Cairo UniversityHanan elabhar, Professor, Study chair, Cairo UniversityMona Schaalan, assoc. prof., Study chair, Misr International UniversityAmr Shafik, Assoc. Prof, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808624
- Sponsor's protocol ID
- PT(1451)
- Status last verified
- Apr 2017
- First submitted
- 20 May 2016
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Prophylactic Effect of Exogenous Antioxidant ''L-CARNOSINE'' on Oxaliplatin-induced Peripheral Neuropathy in Cancer Patients
- ClinicalTrials.gov ID
- NCT02808624
- Acronym / sponsor ID
- PT(1451)
- Conditions
- Peripheral Neuropathy, Cancer
- Keywords
- Oxaliplatin, peripheral neuropathy, L-CARNOSINE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Misr International University, Ain Shams University
- Study start
- Jun 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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.
This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And then neuropathy together with some oxidative stress markers will be assessed at the end of treatment duration (three months) .
Detailed description
Oxaliplatin causes peripheral neuropathy , L-CARNOSINE is supposed to prevent this side effect possibly by reducing oxidative stress and enhancing the growth of nerves.This study is intended to clarify the effect and mechanism of action of L-CARNOSINE in preventing Oxaliplatin induced peripheral neuropathy in cancer patients.
Blood samples will be collected from the patients before starting the chemotherapy and at the end of treatment duration (3 months) and then oxidative stress markers will be measured in these samples
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: L-CARNOSINEthis arm will receive L-CARNOSINE PO (each patient will receive 1 tablet daily and each tablet contains 500 mg thus a total of 500 mg per day) together with their chemotherapy wich is oxaliplatin. |
| Control group | No intervention | –This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients are eligible to be enrolled in this study, if they meet the following criteria
- Elderly males and females with age (˃18 and ˂60).
- Cancer patients treated with oxaliplatin for the first time (dose 85- 135mg/m2) administered every two to three weeks for 3 months.
Key exclusion criteria (10 listed)
- Suffering from diabetes mellitus.
- Suffering from peripheral neuropathy as a result of any other disease or drug.
- Suffering from severe renal impairment (CrCl ˂ 30 ml/min).
- Suffering from epilepsy.
- Taking vitamin B.
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 |
|---|---|---|
| L-CARNOSINEAlso: CARNOSINEL-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy. | Drug | Treatment group |
Primary outcome
Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits.
Time frame: Three months
The following markers will be measured by ELISA kits : Nrf2 induced oxidative stress pathways (GSH) NF-KB anti-inflammatory pathway (TNF- alpha) pro-apoptic signals (caspase 3)
1 secondary outcome
Assessment of tumor markers (CA,CEA) in blood.
Time frame: Three months
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 24 Apr 2017.
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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. This study is not recruiting at the moment.
Samira Saleh, Professor study director
Cairo University
Hanan elabhar, Professor study chair
Cairo University
Mona Schaalan, assoc. prof. study chair
Misr International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing L-CARNOSINE in people with Peripheral Neuropathy and Cancer, run by Cairo 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 3 inclusion and 10 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 24 Apr 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits. (time frame: Three months). 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 24 Apr 2017.