Buprenorphine for Mucositis in Head and Neck Cancer

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Must not be taking: Opioid antagonists, Methadone, Antidepressants, Antipsychotics

Disqualifiers: Substance abuse, Metastasis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

20 Participants Needed

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 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.

My cancer is in my mouth, throat, or voice box.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiation therapy for head and neck cancer

9 weeks

Weekly visits for radiation therapy

Treatment

Participants receive transdermal buprenorphine and oral tramadol for pain management

9 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Treatment Details

Interventions

• Buprenorphine

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.

Buprenorphine is already approved in United States, European Union for the following indications:

Approved in United States as Buprenorphine for:

• Moderate to severe opioid addiction (dependence)

Approved in European Union as Buprenorphine for:

• Opioid dependence

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+