Preventive Approach Using Venlafaxine

Study Overview
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Brief Summary
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Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.

Detailed Description
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Neurologic complications of anticancer therapy may result from direct toxic effects on the nervous system or via indirectly induced metabolic derangements or cerebrovascular disorders. A wide range of neurologic complications can associate antineoplastic drug treatment. Among the widely used anticancer drugs are the platinum-based compounds cisplatin and oxaliplatin which are the most commonly associated with various forms of neurotoxicity. Moreover, taxanes (paclitaxel) are also associated with neurotoxicity. In a double-blind trial in which 48 patients who treated with oxaliplatin-induced acute neurotoxicity were randomly assigned to venlafaxine (37.5 mg extended release twice daily from day 2 to 11) or placebo, however the 2014 systematic review of neuroprotectants from ASCO concluded that the venlafaxine data were not strong enough to recommend its use in clinical practice, until additional supporting data become available. patients will be randomly assigned to treatment arms: Arm A: to receive venlafaxine hydrochloride 75 mg (Effexor X.R) 75mg once daily from day 1 to day 7 to avoid need of dose tapering . Arm B: to receive Gabapentin 100-400 mg once daily from day 1 to day 7.

Official Title
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Clinical Study on Chemotherapy Induced Peripheral Neuropathy: Preventive Approach Using Venlafaxine

Conditions
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Peripheral Neuropathy Due to Chemotherapy

Intervention / Treatment
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* Drug: Venlafaxine 75 MG
* Drug: Gabapentin 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >24 years of age, men or women to lower risk of suicidal tendency. Patients with histologically proven cancer Patients receiving oxaliplatin or taxanes-based regimen WHO performance status of 0-2 serum AST or ALT no higher than two times the upper limit of normal serum creatinine level less than 2 mg/dL platelet count of at least 100,000/mm3 absolute neutrophil count of at least to 1.0 G/L Female patients, those with a negative urine pregnancy test. Exclusion Criteria: Patients with brain or leptomeningeal metastasis. Patients with previous platinum-based chemotherapy Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions. Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venlafaxine Arm<br>Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens. | Drug: Venlafaxine 75 MG<br>* Venlafaxine 75 mg extended release capsules for a 7-days duration<br>|
| Active Comparator: Gabapentin Arm<br>Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens. | Drug: Gabapentin 400 mg<br>* Gabapentin 400 mg capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of grade II or more peripheral neuropathy | Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The EORTC QLQ-CIPN20 subscales | Sensory subscale, motor, and autonomic subscales of CIPN20 | 4 months | 
| Pain Severity | The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF) | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral neuropathy, Taxanes, oxaliplatin, Chemotherapy, Venlafaxine