Clinical trial NCT02397486: The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Incidence and severity of radiotherapy-induced toxicity
timeFrame: 90 days since start of treatment
Secondary outcomes:
measure: Duration of grade 3 or 4 radiotherapy-induced toxicity
timeFrame: 90 days since start of treatment
measure: Patients' response to concurrent chemo-radiotherapy (objective response rate)
timeFrame: 63 days since start of treatment
measure: incidence and grade of pentoxifylline and vitamin E- related adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03)
timeFrame: 90 days since start of treatment
measure: Number of patients with unplanned breaks in radiotherapy
timeFrame: 49 days since start of treatment
measure: Total dose of opioid analgesics required
timeFrame: 90 days since start of treatment
measure: Functional oral intake score
timeFrame: 90 days since start of treatment
measure: Patients' quality of life assessed using the validated Arabic version of the EuroQol-5D-3L questionnaire
timeFrame: 90 days since start of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
citation: Sayed R, El Wakeel L, Saad AS, Kelany M, El-Hamamsy M. Pentoxifylline and vitamin E reduce the severity of radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients: a randomized, controlled study. Med Oncol. 2019 Nov 21;37(1):8. doi: 10.1007/s12032-019-1334-5.