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

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: alpha-Tocopherol; Cisplatin; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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)