NeuropathyPhase 3NCT07287592
Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.
A Phase 3 study testing Glutamine (Pharmacological doses) in people with Neuropathy and Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the efficacy of glutamine in preventing the occurrence of vincristine induced neuropathy and to compare the reduction in rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between those who treated with glutamine and… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Neuropathy, Cancer
- What is being tested?
- Glutamine (Pharmacological doses)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2025to 30 Apr 2027
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- No sex predilection.
- Age: 6 years to 18 years
- Children and adolescents diagnosed with hematological malignancy or solid tumors expected to receive a cumulative dose of 6 mg/m2 of VCR over a 12 week period (or >6 mg/m2 if individual VCR doses were capped at 2 mg) according to their primary cancer treatment protocol
- Patients with score less than 5 on pediatric modified total neuropathy scale at Time 0
Who cannot join
- Patients with CNS tumors
- Patients with focal neurologic findings or CNS metastasis Patients with premorbid developmental disorders, neuromuscular disorders or diabetes mellitus Patients with recurrent disease already exposed to >8 mg/m2 of VCR Patients with score more than 5 on pediatric modified total neuropathy scale
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
nihal hussien aly mostafa, assistant professsor of pediat contact
Egypt1 site
Ain Shams University
Cairo, Cairo Governorate, 11517
nihal hussien aly mostafa, MD of pediatrics, 0224175103, NIHAL.HUSSIEN.ALI@GMAIL.COM
fatma soliman ebeid, MD of pediatrics
About this study
Official title: Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer. A Single Center Study
The goal of this clinical trial is to assess the efficacy of glutamine in preventing the occurrence of vincristine induced neuropathy and to compare the reduction in rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between those who treated with glutamine and those who did not.
Participants will:
Read more
receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for 14 consecutive days from d 1 of induction and 14 days from d1 of continuation .
- Subjects will be asked to return for a complete study assessments visit every 14-days during supplementation period for a total of 4 visits Keep a diary of their symptoms of neuropathy and compliance to treatment and any adverse event
- Conditions
- Neuropathy, Cancer
- Being tested
- Glutamine (Pharmacological doses)
- Keywords
- vincristine, cancer, neuropathy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutamine (Pharmacological doses)Drug
glutamine is an essential amino acid. It will be provided in a powder form. It will be dissolved in at least 8 ounces of hot or cold liquid. It can also be mixed with a soft food such as pudding
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Thirty five patients will receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for forteen consecutive days starting from induction and forteen days starting from d1 of continuation . The dose used in the current study is determined by prior adult studies described a significant beneficial effect of glutamine on oxaliplatin and paclitaxel-induced peripheral neuropathy (Wang et al., 2007) Receives: Drug: Glutamine (Pharmacological doses) |
| Standard of care arm | No intervention | the usual standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety outcome
The primary safety endpoint was the the number of participants who will report bleeding tendency episodes and number of participants with significant impairment of liver or kidney functions
Measured: 12 months
primary objective outcome
the number of participants who develop neuropathy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- A block-randomization scheme will be generated by computer software. Patients fulfilling the inclusion criteria will then be randomly distributed between glutamine and the standard of care therapy in a 1:1 ratio. * Intervention arm: Thirty five patients will receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for forteen consecutive days starting from induction and forteen days starting from continuation . The dose used in the current study is determined by prior adult studies described a significant beneficial effect of glutamine on oxaliplatin and paclitaxel-induced peripheral neuropathy (Wang et al., 2007) * Standard of care arm: Thirty five patients will be assigned as a control group with no medication given
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287592
- Sponsor's protocol ID
- FMASU R 146/2021
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer. A Single Center Study
- ClinicalTrials.gov ID
- NCT07287592
- Acronym / sponsor ID
- FMASU R 146/2021
- Conditions
- Neuropathy, Cancer
- Keywords
- vincristine, cancer, neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Dec 2025 (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 goal of this clinical trial is to assess the efficacy of glutamine in preventing the occurrence of vincristine induced neuropathy and to compare the reduction in rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between those who treated with glutamine and those who did not.
Participants will:
receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for 14 consecutive days from d 1 of induction and 14 days from d1 of continuation .
- Subjects will be asked to return for a complete study assessments visit every 14-days during supplementation period for a total of 4 visits Keep a diary of their symptoms of neuropathy and compliance to treatment and any adverse event
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A block-randomization scheme will be generated by computer software. Patients fulfilling the inclusion criteria will then be randomly distributed between glutamine and the standard of care therapy in a 1:1 ratio. * Intervention arm: Thirty five patients will receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for forteen consecutive days starting from induction and forteen days starting from continuation . The dose used in the current study is determined by prior adult studies described a significant beneficial effect of glutamine on oxaliplatin and paclitaxel-induced peripheral neuropathy (Wang et al., 2007) * Standard of care arm: Thirty five patients will be assigned as a control group with no medication given
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Drug: Glutamine (Pharmacological doses)Thirty five patients will receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for forteen consecutive days starting from induction and forteen days starting from d1 of continuation . The dose used in the current study is determined by prior adult studies described a significant beneficial effect of glutamine on oxaliplatin and paclitaxel-induced peripheral neuropathy (Wang et al., 2007) |
| Standard of care arm | No intervention | –the usual standard of care |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- No sex predilection.
- Age: 6 years to 18 years
- Children and adolescents diagnosed with hematological malignancy or solid tumors expected to receive a cumulative dose of 6 mg/m2 of VCR over a 12 week period (or >6 mg/m2 if individual VCR doses were capped at 2 mg) according to their primary cancer treatment protocol
- Patients with score less than 5 on pediatric modified total neuropathy scale at Time 0
Key exclusion criteria (2 listed)
- Patients with CNS tumors
- Patients with focal neurologic findings or CNS metastasis Patients with premorbid developmental disorders, neuromuscular disorders or diabetes mellitus Patients with recurrent disease already exposed to >8 mg/m2 of VCR Patients with score more than 5 on pediatric modified total neuropathy scale
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 |
|---|---|---|
| Glutamine (Pharmacological doses)glutamine is an essential amino acid. It will be provided in a powder form. It will be dissolved in at least 8 ounces of hot or cold liquid. It can also be mixed with a soft food such as pudding | Drug | Intervention arm |
Primary outcome
safety outcome
Time frame: 12 months
The primary safety endpoint was the the number of participants who will report bleeding tendency episodes and number of participants with significant impairment of liver or kidney functions
primary objective outcome
Time frame: 3 months
the number of participants who develop neuropathy
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 17 Dec 2025.
- 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.
nihal hussien aly mostafa, assistant professsor of pediat contact
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 Glutamine (Pharmacological doses) in people with Neuropathy and Cancer, run by Ain Shams 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Dec 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?
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 nihal hussien aly mostafa, assistant professsor of pediat (+201001053961, nihal.hussien.ali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety outcome (time frame: 12 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 17 Dec 2025.