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

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397486
• Other study ID #: Ph.D 20
• Status: Completed
• Phase: Phase 2
• Start date: May 2, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• Pentoxifylline

• Vitamin E

• Cisplatin

Radiation:
• Radiation therapy

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of grade 3 or 4 radiotherapy-induced toxicity		90 days since start of treatment
Secondary	Patients' response to concurrent chemo-radiotherapy (objective response rate)	the effect of pentoxifylline and vitamin E on the	63 days since start of treatment
Secondary	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
Secondary	Number of patients with unplanned breaks in radiotherapy		49 days since start of treatment
Secondary	Total dose of opioid analgesics required		90 days since start of treatment
Secondary	Functional oral intake score		90 days since start of treatment
Secondary	Patients' quality of life assessed using the validated Arabic version of the EuroQol-5D-3L questionnaire		90 days since start of treatment