Head and Neck Neoplasms
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGPentoxifylline
DRUGVitamin E
DRUGCisplatin
RADIATIONRadiation therapy
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of radiotherapy-induced toxicity | 90 days since start of treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' response to concurrent chemo-radiotherapy (objective response rate) | 63 days since start of treatment | the effect of pentoxifylline and vitamin E on the |
| incidence and grade of pentoxifylline and vitamin E- related adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03) | 90 days since start of treatment | Adverse events induced by intervention drugs will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 |
| Number of patients with unplanned breaks in radiotherapy | 49 days since start of treatment | — |
| Duration of grade 3 or 4 radiotherapy-induced toxicity | 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 | — |
| Total dose of opioid analgesics required | 90 days since start of treatment | — |
Countries
Egypt
Outcome results
None listed