The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients
- Conditions
- Head and Neck Neoplasms
- Interventions
- Registration Number
- NCT02397486
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Radiation therapy 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. Control Group Radiation therapy Platinum based concurrent chemoradiotherapy \[cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks\] . Intervention Group Cisplatin 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. Intervention Group Pentoxifylline 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. Intervention Group Vitamin E 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. Control Group Cisplatin Platinum based concurrent chemoradiotherapy \[cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks\] .
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Patients' response to concurrent chemo-radiotherapy (objective response rate) 63 days since start of treatment the effect of pentoxifylline and vitamin E on the
Duration of grade 3 or 4 radiotherapy-induced toxicity 90 days since start of treatment Number of patients with unplanned breaks in radiotherapy 49 days since start of treatment Functional oral intake score 90 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) 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
Total dose of opioid analgesics required 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
Trial Locations
- Locations (1)
Ain Shams University Hospitals
🇪🇬Cairo, Egypt