NCT02397486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

3.2 years

First QC Date

March 16, 2015

Last Update Submit

November 23, 2019

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Duration of grade 3 or 4 radiotherapy-induced toxicity

    90 days since start of treatment

  • Patients' response to concurrent chemo-radiotherapy (objective response rate)

    63 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

  • Number of patients with unplanned breaks in radiotherapy

    49 days since start of treatment

  • Total dose of opioid analgesics required

    90 days since start of treatment

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Drug: PentoxifyllineDrug: Vitamin EDrug: CisplatinRadiation: Radiation therapy

Control Group

ACTIVE COMPARATOR

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

Drug: CisplatinRadiation: Radiation therapy

Interventions

PentoxifyllineDRUG
Also known as: Trental
Intervention Group
Vitamin EDRUG
Intervention Group
CisplatinDRUG
Control GroupIntervention Group
Radiation therapyRADIATION
Control GroupIntervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

Related 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. doi: 10.1007/s12032-019-1334-5.

    PMID: 31748905RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

PentoxifyllineVitamin ECisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzopyransPyransHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer- Clinical Pharmacy Department

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 25, 2015

Study Start

May 2, 2015

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

EG(1)