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

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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. The detrimental effects of salivary enzymes on tissue healing and surgical anastomoses are addressed and novel treatment strategy is outlined.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization; Jeff Weinberger
• Treatments: Octreotide

Criteria

Inclusion Criteria:

• Chemoradiation

• Total laryngectomy

• Composite resections for oral/pharyngeal/laryngeal malignant tumors

Exclusion Criteria:

• Pregnancy

• Patients with malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means

• Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/d