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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Impact of Pentoxifylline and Vitamin E on The Incidence and Severity of Radiotherapy- Induced Oral Mucositis and Dysphagia in Patients With Head and Neck Cancer

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Drug: Pentoxifylline
* Drug: Vitamin E
* Drug: Cisplatin
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Drug: Pentoxifylline<br> <br> * Other names: Trental;Drug: Vitamin E<br> <br> Drug: Cisplatin<br> <br> Radiation: Radiation therapy<br> <br> |
| Active Comparator: Control Group<br>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] . | Drug: Cisplatin<br> <br> Radiation: Radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90 days since start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of grade 3 or 4 radiotherapy-induced toxicity |  | 90 days since start of treatment | 
| Patients' response to concurrent chemo-radiotherapy (objective response rate) | the effect of pentoxifylline and vitamin E on the | 63 days since start of treatment | 
| incidence and grade of pentoxifylline and vitamin E- related adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03) | Adverse events induced by intervention drugs will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 | 90 days since start of treatment | 
| Number of patients with unplanned breaks in radiotherapy |  | 49 days since start of treatment | 
| Total dose of opioid analgesics required |  | 90 days since start of treatment | 
| Functional oral intake score |  | 90 days since start of treatment | 
| Patients' quality of life assessed using the validated Arabic version of the EuroQol-5D-3L questionnaire |  | 90 days since start of treatment |