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Opioid Analgesic

Buprenorphine for Mucositis in Head and Neck Cancer

Phase 2

Waitlist Available

Led By Stuart J. Wong, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 18-80 years

Histologically confirmed malignancies involving the oral cavity, oropharynx, hypopharynx and larynx (including non-squamous cell histologies, salivary gland carcinomas and unknown primary tumors)

Must not have

Patients with history of seizure disorder as oral tramadol may reduce seizure threshold.

Patients on systemic therapy (chemotherapy or immunotherapy) for another cancer subtype

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 9.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if using buprenorphine can help lessen radiation-induced mucositis pain in cancer patients who have head and neck tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Buprenorphine may cause side effects like nausea, dizziness, sweating, constipation, headache, or sleepiness. Tramadol could potentially lower seizure threshold leading to seizures especially if there's a history of seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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

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I can use a smartphone and its apps, or I don't have one but can use a provided device.

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My kidney function is good enough for the trial.

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I can take care of myself and am up and about more than half of my waking hours.

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I can speak and read English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

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

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I haven't had abdominal surgery or acute GI conditions like colitis in the last 60 days.

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I am currently taking medication for depression or psychosis.

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I have a history of severe asthma or serious breathing problems, and no blockages in my stomach or intestines.

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I am not pregnant or breastfeeding.

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I have an ongoing mouth infection or side effects from previous radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 9.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 9.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 9. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of subjects who achieve at least a 30 percent decrease in pain from baseline in VAS pain score calculated from BPI questionnaire.

Secondary study objectives

The number of subjects who achieve at least a 30 percent decrease in pain from baseline in average daily pain score calculated by OM pain app.

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167

17%

Nausea

Constipation

Vomiting

Headache

Dizziness

Somnolence

Drug withdrawal syndrome

100%

80%

60%

40%

20%

Study treatment Arm

OL Buprenorphine HCl Buccal Film

DB Buprenorphine HCl Buccal Film

DB Placebo Film

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Drug TreatmentExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buprenorphine

2014

Completed Phase 4

~2600

Tramadol

2014

Completed Phase 4

~3320