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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

Tracking Information
First Submitted Date  ICMJE March 10, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE March 29, 2018
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • Incidence of Vincristine Induced neurotoxicity [ Time Frame: Cumulative incidence at 5th week of vincristine chemotherapy ]
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03593304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Vincristine Induced Neurotoxicity
  • Acute Lymphoblastic Leukaemia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Injection Mecobalamin
    • Drug: Tablet Pyridoxine hydrochlorid
  • 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.
    Interventions:
    • Drug: Normal saline
    • Drug: Oral Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ferdaush Ahmed Sojib, MBBS +8801678792930 ferdaushahmedsojib@gmail.com
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03593304
Other Study ID Numbers  ICMJE No. BSMMU/2018/2105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferdaush Ahmed Sojib, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Sponsor  ICMJE Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP