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Opioid Analgesic

Buprenorphine for Mucositis in Head and Neck Cancer

Phase 2

Recruiting

Led By Aditya Shreenivas, 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 9.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,563 Total Patients Enrolled

Aditya Shreenivas, MDPrincipal Investigator - Medical College of Wisconsin

Froedtert & The Medical College of Wisconsin

Stuart J. Wong, MDPrincipal InvestigatorMedical College of Wisconsin

4 Previous Clinical Trials

159 Total Patients Enrolled

Media Library

Buprenorphine (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04752384 — Phase 2

Head and Neck Squamous Cell Carcinoma Research Study Groups: Drug Treatment

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT04752384 — Phase 2

Buprenorphine (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752384 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept applicants who are more than 25 years old?

"Individuals aged 18 to 80 are eligible for participation in this clinical trial."

Answered by AI

To what conditions is Buprenorphine commonly administered as a remedy?

"Buprenorphine can be employed to combat the symptoms of pain, opioid dependence, and acute pain."

Answered by AI

Is enrollment for this clinical experiment still available?

"Per the information on clinicaltrials.gov, this medical trial is in search of participants at the moment; it first appeared online back on July 8th 2021 and most recently updated on July 14th 2022."

Answered by AI

Has Buprenorphine been tested as a therapeutic agent in any other research studies?

"Presently, there are 53 studies related to Buprenorphine taking place around the world and 16 of them have reached Phase 3. Of these 231 locations conducting trials for Buprenorphine, most are located in Durham, North carolina."

Answered by AI

What is the size of the cohort involved in this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this medical study, which was opened on July 8th 2021, is actively searching for participants. The trial necessitates 20 volunteers from a single location to be enrolled."

Answered by AI

Has the Food and Drug Administration authorized Buprenorphine?

"Taking into account that there is only safety data available, our team at Power has assigned Buprenorphine a score of 2 on the 1-3 scale."

Answered by AI

What criteria must I meet to be eligible for participation in this trial?

"This research endeavour is looking to recruit 20 individuals over 18 years of age who are suffering from oral squamous cell carcinoma. The eligibility criteria includes being aged between 18 and 80, receiving radiotherapy or chemo-radiotherapy with a minimum 50 Gy dosage to the head/neck region (previously treated patients also qualify), an Eastern Cooperative Oncology Group Performance Status no greater than 2, concurrent enrollment in other interventional trials allowed, taking non-opioid based medications like viscous lidocaine or magic mouthwash but not Tylenol for fever and mild pain before starting drug regimen."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients

Stuart Wong 2021. "Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752384.

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