Buprenorphine for Mucositis in Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Stuart J. Wong, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Medical College of Wisconsin

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a single-arm prospective clinical trial to determine the safety and feasibility of using transdermal buprenorphine in alleviation of radiation induced mucositis pain in head and neck cancer patients.

Research Team

Stuart J. Wong, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

Adults aged 18-80 with head and neck cancer undergoing radiation, possibly with chemotherapy. They must have good organ function, no history of substance abuse or certain heart conditions, not be on antidepressants or antipsychotics, and can't be pregnant. Participants need to understand consent forms and use a smartphone app for pain assessment.

Inclusion Criteria

I am between 18 and 80 years old.

I am receiving or have received radiation of at least 50 Gy to my head/neck, with or without chemotherapy.

My liver and kidneys are functioning well, and my blood counts are suitable for chemotherapy.

Exclusion Criteria

I am currently receiving chemotherapy or immunotherapy for a different type of cancer.

I have cancer that has spread to distant parts of my body but can be surgically removed.

I have a condition like ALS, epilepsy, or brain injury that affects my brain's protective barrier.

Treatment Details

Interventions

• Buprenorphine (Opioid Analgesic)

Trial Overview The trial is testing transdermal buprenorphine's safety and effectiveness in reducing mucositis pain caused by radiation therapy in head and neck cancer patients. It's a single-arm study where all participants receive the same treatment without comparison to another group.

Participant Groups

Group I: Drug Treatment Experimental Treatment 3 Interventions

The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Dr. Joseph E. Kerschner

Medical College of Wisconsin

Chief Medical Officer since 2011

MD, specific institution not identified

Dr. John R. Raymond, Sr.

Medical College of Wisconsin

Chief Executive Officer since 2010

MD from the Medical University of South Carolina