The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients

Ain Shams University60 enrolled

Overview

The purpose of this study is to determine whether pentoxifylline and vitamin E are effective in prevention of radiotherapy- induced toxicity in head and neck cancer patients treated with concurrent chemoradiotherapy.

This is a randomized controlled prospective study of pentoxifylline and vitamin E given on daily basis throughout the period of concurrent chemoradiotherapy to patients with carcinoma of the head and neck. All patients will be followed up to 90 days since the first day of treatment. The incidence and severity of adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms

Interventions

PentoxifyllineDRUG

Vitamin EDRUG

CisplatinDRUG

Radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients * Measurable disease * Patients with squamous cell carcinoma of the head and neck eligible for treatment with concurrent chemo- radiotherapy * Able to understand and willing to sign a written informed consent document Exclusion Criteria: * Pregnant or lactating women, since imaging cannot be done in this setting. * Patients treated with vitamin E and/ or pentoxifylline for any other indication * Patients with recent cerebral and/or retinal hemorrhage * Patients who have previously exhibited intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine. * Patients treated with oral anticoagulants. * Absolute neutrophil count ≤1.5×109/L * Platelets ≤100×109/L * AST ≥ 2.5 X institutional upper limit normal (ULN) * Serum creatinine ≥ 1.5 mg% for males \& 1.4 mg% for females * Serum bilirubin ≥ 1.5X institutional upper limit normal (ULN)

Locations (1)

Ain Shams University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

Incidence and severity of radiotherapy-induced toxicity

weekly follow-up for recording radiotherapy-induced toxicity occurrence.weekly reported toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03