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

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Head and Neck Neoplasms

Treatments: Drug: Vitamin E; Radiation: Radiation therapy; Drug: Cisplatin; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT02397486

Ph.D 20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Platinum based concurrent chemoradiotherapy \[cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks\] . Pentoxifylline 400 mg oral tablets twice daily for 7 weeks. Vitamin E 1000 mg oral capsules once daily for 7 weeks.

Treatment:

Drug: Pentoxifylline

Drug: Vitamin E

Radiation: Radiation therapy

Drug: Cisplatin

Control Group

Active Comparator group

Description:

Platinum based concurrent chemoradiotherapy \[cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks\] .

Treatment:

Radiation: Radiation therapy

Drug: Cisplatin