Preventive Approach Using Venlafaxine

Sponsor

Mit Ghamr Oncology Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05875610

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy Due to Chemotherapy	Drug: Venlafaxine 75 MG Drug: Gabapentin 400 mg	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Venlafaxine Arm

Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.

Drug: Venlafaxine 75 MG

Venlafaxine 75 mg extended release capsules for a 7-days duration

Active Comparator: Gabapentin Arm

Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.

Drug: Gabapentin 400 mg

Gabapentin 400 mg capsules

Outcome Measures

Primary Outcome Measures

The incidence of grade II or more peripheral neuropathy [4 months]
Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.