Clinical trial NCT05875610: Preventive Approach Using Venlafaxine
Official title: Clinical Study on Chemotherapy Induced Peripheral Neuropathy: Preventive Approach Using Venlafaxine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Neuropathy Due to Chemotherapy
Keywords: Peripheral neuropathy
Taxanes
oxaliplatin
Chemotherapy
Venlafaxine
Lead sponsor: Mit Ghamr Oncology Center
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

1. 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 .
2. Arm B: to receive Gabapentin 100-400 mg once daily from day 1 to day 7.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of grade II or more peripheral neuropathy
timeFrame: 4 months
Secondary outcomes:
measure: The EORTC QLQ-CIPN20 subscales
timeFrame: 4 months
measure: Pain Severity
timeFrame: 4 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mit Ghamr Oncology Center
state: Dakahlia
Study officials:
References: