| CTRI Number |
CTRI/2024/05/068162 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Singh Neelam Vijayshankar |
| Designation |
PG student |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, KLE hospital road, Nehru Nagar
Belgaum KARNATAKA 590010 India |
| Phone |
8291666917 |
| Fax |
|
| Email |
neelamsingh21ns@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhilasha Sampagar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Paediatric Hematologist Oncologist,Department of Medical oncology, Jawaharlal Nehru Medical College, KLE Hospital road, Nehru Nagar
Belgaum KARNATAKA 590010 India |
| Phone |
9686187023 |
| Fax |
|
| Email |
abhilasha.pedia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhilasha Sampagar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Paediatric Hematologist Oncologist,Department of Medical oncology, Jawaharlal Nehru Medical College, KLE Hospital road, Nehru Nagar
Belgaum KARNATAKA 590010 India |
| Phone |
9686187023 |
| Fax |
|
| Email |
abhilasha.pedia@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Belagavi, Karnataka 590010, India |
|
|
Primary Sponsor
|
| Name |
Dr Singh Neelam Vijayshankar |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, KLE Hospital road, Nehru Nagar, Belgaum, Karnataka,590010 India |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Singh Neelam Vijayshankar |
KLEs Dr Prabhakar kore hospital, belgavi |
Department of Paediatrics, Jawaharlal Nehru Medical Colleg, Nehru Nagar, KLE hospital road, Belagavi Belgaum KARNATAKA |
8291666917
neelamsingh21ns@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of vitamin E and viatmin B6 combination versus placebo drug |
Capsule Vitamin E of dosage 40mg/kg orally for 35 days and tab vitamin B6 150mg/m2 orally for 35 days, these 2 drug combination versus placebo drug once a day, orally for 35 days will be given in paediatric patients with ALL in induction phase of chemotherapy . |
| Intervention |
Vitamin E and vitamin B6 |
Patients will be randomized into two groups. Intervention arm from day 1 will be subjected to combination of vitamin E 40mg/kg and vitamin B6 150mg/m2 along with induction chemotherapy. Placebo arm from day 1 will receive placebo drug along with induction chemotherapy. Capsule vitamin E of dosage 40mg/kg will be given orally for 35 days. Tab Vitamin B6, dose will be 150mg/m2, will be given orally for 35 days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All newly diagnosed case of paediatric ALL and lymphoid lymphoma between 1 to 18 years |
|
| ExclusionCriteria |
| Details |
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 chemotherapy |
Study will be conducted over a period of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 neurotoxicity |
Study will be conducted over a period of 1 year. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Leukemia’s account for approximately 40-50% of childhood cancer burden in India with acute lymphoblastic leukemia being the commonest type. Acute lymphoblastic leukemia accounts for approximately 77% of cases of childhood leukemias. Lymphoblastic lymphoma accounts for 30-40 % . The recent advances in the treatment of leukemia and lymphoblastic lymphoma have resulted in significant improvement in cure rate of childhood malignancies but treatment related morbidities are still a challenge. Treatment of ALL and lymphoblastic lymphoma consists of 5 phases, which includes, Induction, Consolidation, Interim maintenance, Delayed intensification and Maintenance. First phase also known as remission induction, involves treatment for approximately 4 weeks depending on different protocols. This is the most important phase which aims to eradicate the malignant cells from bone marrow thus restoring normal hematopoiesis. The drugs used in this phase are vincristine, l-asparginase, daunorubicin, intrathecal methotrexate and steroids.Chemotherapeutic regimen completion with proper dose and adequate duration is crucial in determining the survival of patients with ALL and lymphoblastic lymphoma. Unfortunately, chemotherapy related toxicities significantly limits the dose and numbers of chemotherapy and may lead to interruption, dose reduction or even premature termination of treatment thus jeopardizing the treatment outcome. Vincristine associated neurotoxicities are one of the most challenging and complex complications of chemotherapy .Vincristine are Vinca alkaloids, a class of microtubule targeting agent that interferes with continuous mitotic divison and cell growth of cancer cells. It is one of the most neurotoxic antineoplastic medicines. Vincristine induced peripheral neurotoxicity (VIPN) is common side effect in paediatric cancer patients accounting for 45% of neuropathy incidence. Vincristine causes central nervous system and cranial nerves toxicities like ptosis, opthalmoplegia, blindness, blurred vison, diplopia, ocular muscle paresis, ototoxicity, SIADH, seizure. Muscular weakness in lower extremities, constipation, jaw pain, hoarseness were some of the other toxicities. VIPN develops due to neurodegenerative and oxidative stress. Moreover, neurotoxicity has negative impact on patient’s quality of life. Several measures like glutamic acid, B12, amitriptyline, pyridoxine and pyridostigmine have been used to treat vincristine induced peripheral neuropathy(VIPN). However, there is paucity of literature regarding the role of vitamin E and pyridoxine combination in prevention of VIPN. Vitamin B6 is an essential cofactor in synthesis of myelin sheath. It also has antioxidant property. There have been several randomized phase II studies looking at Vitamin E as neuroprotective agent. So we plan this study to determine whether vitamin B6 and vitamin E can prevent and or reduce the severity of vincristine induced neurotoxicity during induction phase of ALL and lymphoblastic lymphoma which can eventually reduce treatment interruptions and morbidities during the most crucial phase of treatment, thus improving the treatment outcome. |