Does a combination of medications (Pentoxifylline and Vitamin E) affect hardening of tissues in throat following head and neck cancer treatment?

Pilot study of the effect of adjuvant Pentoxifylline and Vitamin E on compliance of pharyngoesophageal junction after endoscopic dilatation.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001575224

Enrollment

Registered

2018-09-20

Start date

2018-10-01

Completion date

2019-10-01

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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

Outcome results