To find out the effect of vitamin B6 and vitamin E in preventing neurological side effects caused due to cancer drug vincristine in children with blood cancer in first cycle of chemotherapy

Impact of pyridoxine and vitamin E combination in preventing vincristine associated neurotoxicity in paediatric patients with hematolymphoid malignancies during induction phase of chemotherapy: A Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068162

Enrollment

Registered

2024-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Nerve conduction velocity test Flow Cytometry Immunohistochemistry Serum Methylmalonic acid: Baseline serum Methylmalonic acid test will be done to rule out vitamin B 12 deficiency.Flow

Eligibility

Inclusion criteria

Inclusion criteria: All newly diagnosed case of paediatric ALL and lymphoid lymphoma between 1 to 18 years

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with CNS leukemia 2. Patients who are on anti-convulsant like gabapentin, lamotrigine, levetiracetam, lorazepam,, midazolam, carbamazepine 3. Patients who are on anti depressants like fluoxetine, fluvoxamine, sertraline, olanzapine 4 Established neurological condition like CP 5 Patients on therapeutic dose of azoles

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of pyridoxine and vitamin E combination in preventing vincristine induced neurotoxicity in paediatric patients with ALL and lymphoid lymphoma during induction phase of chemotherapyTimepoint: Study will be conducted over a period of 1 year.	—

Secondary

Measure	Time frame
1 to determine incidence of chemotherapy related toxicity during induction phase of chemotherapy 2 To compare common terminology criteria for adverse events (CTCAE) and total neuropathy score -pediatric vincristine (TNSPV) with electrodiagnosis testing in assessing VCR induced neurotoxicityTimepoint: Study will be conducted over a period of 1 year.	—

Countries

India

Contacts

Public ContactDr Abhilasha Sampagar

Jawaharlal Nehru Medical College, KLE University

abhilasha.pedia@gmail.com9686187023

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026