Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001575224
Ethics application status
Approved
Date submitted
5/09/2018
Date registered
20/09/2018
Date last updated
20/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a combination of medications (Pentoxifylline and Vitamin E) affect hardening of tissues in throat following head and neck cancer treatment?
Scientific title
Pilot study of the effect of adjuvant Pentoxifylline and Vitamin E on compliance of pharyngoesophageal junction after endoscopic dilatation.
Secondary ID [1] 295992 0
None
Universal Trial Number (UTN)
U1111-1219-9233
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
strictures post head and neck radiotherapy 309509 0
dysphagia 309510 0
Condition category
Condition code
Cancer 308342 308342 0 0
Head and neck
Oral and Gastrointestinal 308343 308343 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral capsules of Pentoxifylline and Vitamin E, three times a day for 12 weeks, combined daily dose of 1,200mg of Pentoxifylline and 1,000IU Vitamin E

Adherence to prescribed treatment will be assessed by bottle return and tablet count.
Intervention code [1] 312321 0
Treatment: Drugs
Comparator / control treatment
Placebo microcellulose capsules identical to the active tablets, three times a day for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 307327 0
Dysphagia symptom severity assessed by validated Sydney Swallow Questionnaire
Timepoint [1] 307327 0
12 months from start of treatment
Secondary outcome [1] 351488 0
Pharyngeal compliance assessed by Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
Timepoint [1] 351488 0
12 months from start of treatment

Eligibility
Key inclusion criteria
Completion of radiotherapy with or without adjuvant chemotherapy and dysphagia symptoms defined as Sydney Swallow Questionnaire > 234 (upper limit of normal).

Clinical indication for endoscopic dilatation demonstrating a pharyngo-oesophageal junction stricture confirmed by EndoFLIP defined as compliance below the established lower limit of normal (CSA < 4.0 mm2/mmHg).

No Vitamin E supplementation at least 2 weeks* before commencement on study medication and willingness to abstain from Vitamin E supplements including multivitamin formulations containing Vitamin E for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who cannot provide informed consent due to any reason (language barrier, impaired cognitive function).

Recurrence or persistent disease following head and neck cancer treatment.
Pre-existing disorder known to cause pharyngeal dysphagia such as: MVA, MND, Parkinson’s, inflammatory myopathy.

Pre-existing oesophageal disease known to cause dysphagia such as eosinophilic oesophagitis, achalasia, oesophageal cancer.

Either current pregnancy, intended pregnancy or breastfeeding during the study

History of severe haemorrhage, e.g. massive retinal haemorrhage, cerebral haemorrhage, acute myocardial infarction or recent history of peptic ulcer.

Concomitant or recent use of Warfarin or impaired blood clotting.

Previous intolerance to Pentoxifylline or other methylxanthines such as caffeine, theophylline, and theobromine.

Significant impairment of renal or hepatic function or other co-morbid conditions which in the opinion of the investigators preclude inclusion in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization and allocation concealment will be carried out by an "off site" pharmacy. Investigators will issue medication to the participants based on sequentially numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
blocked randomization with random block sizes (2 & 4) stratified by 1) treatment naive and 2) previous dilatation(s).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
1/10/2019
Actual
Date of last data collection
Anticipated
1/10/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11781 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 23907 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 300587 0
University
Name [1] 300587 0
The Translational Cancer Research Network. The University of New South Wales
Country [1] 300587 0
Australia
Primary sponsor type
University
Name
Department of Gastroenterology and Hepatology, University of New South Wales
Address
Department of Gastroenterology and Hepatology
St George Clinical School
St George Hospital
Kogarah, NSW, 2217
Country
Australia
Secondary sponsor category [1] 300100 0
None
Name [1] 300100 0
Address [1] 300100 0
Country [1] 300100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301374 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301374 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2813
Ethics committee country [1] 301374 0
Australia
Date submitted for ethics approval [1] 301374 0
31/05/2018
Approval date [1] 301374 0
16/08/2018
Ethics approval number [1] 301374 0
18/145

Summary
Brief summary
Fibrosis, or hardening of tissues is a common side effect following cancer treatment, particularly radiotherapy. Evidence exists that combined treatment using Pentoxifylline (PTX) and Vitamin E (Vit E) reduces and even reverses fibrosis in breast cancer. This treatment is used at times in head and neck cancer but is not considered ‘routine’ treatment. The purpose of this study is to see whether this treatment can prevent relapse of hardened tissues in those with narrowing (called stricture) of the throat following head and neck cancer treatment.

Who is it for?
You may be eligible for this study if you are an adult who has completed treatment for head and neck cancer.

Study details
Participants will be randomly allocated to one of two groups:
Group 1: 12 weeks of medication (pentoxifylline and vitamin E).
Group 2: 12 weeks of placebo treatment.
All participants will then be assessed one year later by endoscopy to measure the hardness of tissue in their throat.
It is hoped that this study will demonstrate that this treatment is effective in reducing relapse of fibrosis in patients who have been treated with head and neck cancer.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3078 3078 0 0
/AnzctrAttachments/375934-Protocol PTX_VitE_ v3.0 - clean.pdf (Protocol)
Attachments [2] 3079 3079 0 0
/AnzctrAttachments/375934-2018.08.16 HREC Ethics Approval 18-145.pdf (Ethics approval)
Attachments [3] 3080 3080 0 0
/AnzctrAttachments/375934-PISCF_PTX_VITE_v3.0 - clean.pdf (Participant information/consent)

Contacts
Principal investigator
Name 86794 0
A/Prof Peter Graham
Address 86794 0
Department of Radiation Oncology - Cancer Care Centre
St George Hospital
1 Short St
Kogarah, NSW, 2217
Country 86794 0
Australia
Phone 86794 0
+61 02 91133903
Fax 86794 0
Email 86794 0
[email protected]
Contact person for public queries
Name 86795 0
Dr Michal Szczesniak
Address 86795 0
Department of Gastroenterology and Hepatology
St George Hospital
Gray St
Kogarah, NSW, 2217
Country 86795 0
Australia
Phone 86795 0
+61 02 91132878
Fax 86795 0
Email 86795 0
[email protected]
Contact person for scientific queries
Name 86796 0
Dr Michal Szczesniak
Address 86796 0
Department of Gastroenterology and Hepatology
St George Hospital
Gray St
Kogarah, NSW, 2217
Country 86796 0
Australia
Phone 86796 0
+61 02 91132878
Fax 86796 0
Email 86796 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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