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Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients

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ClinicalTrials.gov Identifier: NCT03593304
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ferdaush Ahmed Sojib, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary:
This study will be conducted to evaluate the effect of vitamin B6 and vitamin B12 in reducing the incidence and severity and delaying the onset of Vincristine Induced neurotoxicity in Acute Lymphobalstic Leukemia (ALL) patient.

Condition or disease Intervention/treatment Phase
Vincristine Induced Neurotoxicity Acute Lymphoblastic Leukaemia Drug: Injection Mecobalamin Drug: Tablet Pyridoxine hydrochlorid Drug: Normal saline Drug: Oral Placebo Phase 2 Phase 3

Detailed Description:
Acute lymphoblastic leukaemia (ALL) is increasing day by day in less developed countries like Bangladesh. Vincristine is one of the important chemotherapeutic agents used in combination with other medicines to treat Acute Lymphoblastic Leukemia (ALL). Good prognostic outcome of ALL depends on uninterrupted and complete course of chemotherapy. With full course of treatment about 85% of adult patients and 98% of children attain complete recovery. Development of some deleterious adverse effects especially neurotoxicity results in dose reduction, protocol deviation and even abandonment of treatment. About 45% patients develop peripheral neuropathy and more than 33% patients develop autonomic neuropathy who needs dose reduction or treatment protocol deviation. Many studies have been conducted to explore the potential of medicine to prevent or treat neuropathy but still there is no success. This proposed study will be an effort to identify the potential of vitamin B6 (Pyridoxine hydrochloride) and vitamin B12 (Mecobalamin) as preventive measure in reducing the incidence, risk, severity and time of onset of vincristine induced neurotoxicity. This study will be a multicenter, double blind, randomized controlled trial. In this study newly diagnosed ALL patients will be enrolled in induction phase and patients will be randomly allocated into two arms by using online graph pad software. After assessing the baseline characteristics by Eastern Cooperative Oncology Group (ECOG) performance status and Composite Autonomic Symptom Score (COMPASS 31), patient will be provided medicine or placebo. From the day of starting chemotherapy, patients on intervention arm will be administered vitamin B6 and vitamin B12. Vitamin B6 will be given 50 mg thrice daily orally for 5 weeks and Vitamin B12 will be given 500 μg three times weekly intravenously on day 1, 3 and 5 of every week for 5 weeks. On the other hand, patients on placebo arm will be given placebo pill and injection at same interval. Each patient will be evaluated for neurotoxicity on the outset of every 2nd, 3rd, 4th and 5th week by using COMPASS 31 for autonomic neuropathy. Incidence, severity and onset will be compared on both arms. After approval from institutional review board (IRB) every eligible patient will be informed about the intervention and the study. Informed written consent will be taken of the patients who will take part in the study willingly. Patient's anonymity will be maintained and will be used for research purpose only.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental group: Medicine- Injection Mecobalamin (500mcg), Tablet Pyridoxine hydrochloride (25 mg) Placebo group: Injection normal saline (1ml), oral placebo pill
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019


Arm Intervention/treatment
Active Comparator: Experimental:Mecobalamin and Pyridoxine hydrochloride
Injection Mecobalamin (500mcg) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.Tablet Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks.
Drug: Injection Mecobalamin
Injection Mecobalamin (500mcg) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.
Other Name: Vitamin B12

Drug: Tablet Pyridoxine hydrochlorid
Tablet Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks.
Other Name: Vitamin B6

Placebo Comparator: Placebo: normal saline and Oral placebo
Injection normal saline (1ml) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.Oral placebo pill 2 tablets thrice daily for 5 weeks.
Drug: Normal saline
Injection Normal saline(1ml) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.
Other Name: Placebo for mcobalamin

Drug: Oral Placebo
Placebo Oral Tablet (25 mg) 2 tablets thrice daily for 5 weeks.
Other Name: Placebo for pyridoxine hydrochloride




Primary Outcome Measures :
  1. Incidence of Vincristine Induced neurotoxicity [ Time Frame: Cumulative incidence at 5th week of vincristine chemotherapy ]
  2. Severity of Vincristine Induced neurotoxicity [ Time Frame: On the outset of 1st week change in the severity of neurotoxicity on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy ]
    Changes of severity will be assessed by COMPASS 31 on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy

  3. Time of onset of Vincristine Induced Neurotoxicity [ Time Frame: 1st week (baseline), change in neurotoxicity status on the outset 2nd week, 3rd week, 4th week and 5th week of vincristine chemotherapy ]
    change in neurotoxicity status on the outset of 2nd week, 3rd week, 4th week, 5th week of vincristine chemotherapy



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients, 18 years of age or older with newly diagnosed ALL going to start induction chemotherapy with Vincristine
  • Patients ECOG Performance Status 0 to 3
  • Patients with no preexisting autonomic neuropathy
  • Patients with normal renal function (Serum creatinine <1.5 mg/dl)
  • No history of diabetes mellitus
  • Patients agree to participate in the study signing an informed written consent

Exclusion Criteria:

  • Pregnant women and nursing mothers
  • Patients with clinical neuropathy due to diabetes mellitus and other causes like multiple sclerosis, spinal cord injury, post stroke
  • Patients with head neck tumors
  • Patients taking anticonvulsants, antidepressants, opioids, vitamin E and other neuropathic pain medication agents like topical anesthetic agents, non steroidal anti-inflammatory drugs (NSAIDs)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593304


Contacts
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Contact: Ferdaush Ahmed Sojib, MBBS +8801678792930 ferdaushahmedsojib@gmail.com

Locations
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Bangladesh
Bangabandhu Sheikh Mujib Medical University Recruiting
Dhaka, Shahbag, Bangladesh, 1000
Contact: Ferdaush Ahmed Sojib, MBBS    +8801678792930    ferdaushahmedsojib@gmail.com   
Contact: Md. Sayedur Rahman, MBBS, Mphil    +01971840757    srkhasru@gmail.com   
Dhaka Medical College Hospital Recruiting
Dhaka, Bangladesh
Contact: Ferdaush Ahmed Sojib, MBBS    01678792930    ferdaushahmedsojib@gmail.com   
Contact: Tasneem Ara, MBBS,FCPS,Mphil    +8801552314402      
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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Responsible Party: Ferdaush Ahmed Sojib, Resident, Department of Pharmacology, BSMMU, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03593304     History of Changes
Other Study ID Numbers: No. BSMMU/2018/2105
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neurotoxicity Syndromes
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Pyridoxal
Pyridoxine
Vincristine
Vitamin B Complex
Neuroprotective Agents
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents