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

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Pentoxifylline
Vitamin E
Cisplatin
Radiation therapy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ain Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

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] .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of grade 3 or 4 radiotherapy-induced toxicity
Patients' response to concurrent chemo-radiotherapy (objective response rate)
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)
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
Total dose of opioid analgesics required
Functional oral intake score
Patients' quality of life assessed using the validated Arabic version of the EuroQol-5D-3L questionnaire

Full Information

First Posted
March 16, 2015
Last Updated
November 23, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02397486
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Primary Outcome Measure Information:
Title
Incidence and severity of radiotherapy-induced toxicity
Description
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
Time Frame
90 days since start of treatment
Secondary Outcome Measure Information:
Title
Duration of grade 3 or 4 radiotherapy-induced toxicity
Time Frame
90 days since start of treatment
Title
Patients' response to concurrent chemo-radiotherapy (objective response rate)
Description
the effect of pentoxifylline and vitamin E on the
Time Frame
63 days since start of treatment
Title
incidence and grade of pentoxifylline and vitamin E- related adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03)
Description
Adverse events induced by intervention drugs will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time Frame
90 days since start of treatment
Title
Number of patients with unplanned breaks in radiotherapy
Time Frame
49 days since start of treatment
Title
Total dose of opioid analgesics required
Time Frame
90 days since start of treatment
Title
Functional oral intake score
Time Frame
90 days since start of treatment
Title
Patients' quality of life assessed using the validated Arabic version of the EuroQol-5D-3L questionnaire
Time Frame
90 days since start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31748905
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.
Results Reference
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The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients

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