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

NCT ID: NCT02397486

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-02
• Study Completion Date: 2018-06-30

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Pentoxifylline

Intervention Type: DRUG

Vitamin E

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Radiation therapy

Intervention Type: RADIATION

Control Group

Platinum based concurrent chemoradiotherapy \[cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks\] .

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

Radiation therapy

Intervention Type: RADIATION

Interventions

Pentoxifylline

Intervention Type: DRUG

Vitamin E

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Radiation therapy

Intervention Type: RADIATION

Other Intervention Names

Trental

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rana Sayed Fouad

Assistant Lecturer- Clinical Pharmacy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 31748905 (View on PubMed)

Other Identifiers

Ph.D 20

Identifier Type: -

Identifier Source: org_study_id