Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients
Condition: Vincristine Induced Neurotoxicity; Acute Lymphoblastic Leukaemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neurotoxicity Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Injection Mecobalamin; Tablet Pyridoxine hydrochlorid; Normal saline; Oral Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; Injection Normal saline(1ml) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.; Placebo Oral Tablet (25 mg) 2 tablets thrice daily for 5 weeks.
Other intervention name(s): Vitamin B12; Vitamin B6; Placebo for mcobalamin; Placebo for pyridoxine hydrochloride
Intervention MeSH terms: Vitamins; Vitamin B 12; Pyridoxine; Pyridoxal; Vitamin B 6; Vitamin B Complex
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