Octreotide VS Placebo in Prevention of Salivary Fistulae After Post Radiation Salvage Surgery

What Was Tested

This registered phase 2 trial tested Octreotide.

Salivary fistulae have been the bane of surgical salvage in the era of primary chemoradiation for head and neck (H\&N) cancers.

The "blame"of prior chemoradiation tissue damage encouraged compensatory surgical techniques that focused on the insertion of non-irradiated tissue into the field.

This study emphasizes a paradigm shift in the understanding and treatment of pharyngocutaneous fistulae.

It had two arms (groups): octreotide treatment (experimental) and placebo treatment (placebo comparator).

Plasebo will be administrated I.V in the evening prior to surgery and two weeks on a thrice daily basis.

The registry classes the interventions as drug and other.

More on the Plan

After signing an informed consent form, patients scheduled for total laryngectomy or for composite resections for oral/pharyngeal/laryngeal malignant tumors, will be randomly divided into two groups of about ten in each.

The control group will receive a placebo while the study group will receive octreotide.

All involved in the care of the patients and the patients themselves will be blinded to the drug given.

The rest of the treatment will be equal in both groups and will adhere to the current departmental protocols in Otolaryngology/Oral-Maxillofacial Surgery.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Composite resections for oral/pharyngeal/laryngeal malignant tumors.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: patients with malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2015-10 with completion listed for 2021-06.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): elimination of post-radiation salivary fistulae (time frame: up to 7 days after the surgery).

It also tracked 2 secondary outcomes, for example saliva secretion rate and pain evaluation.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.