AzTrials
AzTrials

Head and Neck NeoplasmsPhase 2NCT02397486

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

A Phase 2 study testing Pentoxifylline, Vitamin E and Cisplatin in people with Head and Neck Neoplasms, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
Pentoxifylline, Vitamin E and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
2 May 2015to 30 Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Ain Shams University Hospitals

    Cairo

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
Pentoxifylline, Vitamin E, Cisplatin, Radiation therapy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PentoxifyllineDrug

    Also called Trental

  • Vitamin EDrug

  • CisplatinDrug

  • Radiation therapyRadiation

Study groups in NCT02397486
Study groupRoleWhat they receive
Intervention GroupExperimentalPlatinum 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.
Receives: Drug: Pentoxifylline; Drug: Vitamin E; Drug: Cisplatin; Radiation: Radiation therapy
Control GroupActive comparatorPlatinum 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] .
Receives: Drug: Cisplatin; Radiation: Radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 90 days since start of treatment

Secondary outcomes (7)

  1. Duration of grade 3 or 4 radiotherapy-induced toxicity

    Measured: 90 days since start of treatment

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

    the effect of pentoxifylline and vitamin E on the

    Measured: 63 days since start of treatment

  3. 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

    Measured: 90 days since start of treatment

  4. Number of patients with unplanned breaks in radiotherapy

    Measured: 49 days since start of treatment

  5. Total dose of opioid analgesics required

    Measured: 90 days since start of treatment

  6. Functional oral intake score

    Measured: 90 days since start of treatment

  7. Patients' quality of life assessed using the validated Arabic version of the EuroQol-5D-3L questionnaire

    Measured: 90 days since start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study start2 May 2015
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02397486
Sponsor's protocol ID
Ph.D 20
Status last verified
Nov 2019
First submitted
16 Mar 2015
Last updated
26 Nov 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31748905

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pentoxifylline, Vitamin E and Cisplatin in people with Head and Neck Neoplasms, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of radiotherapy-induced toxicity (time frame: 90 days since start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02397486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in