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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a patch containing buprenorphine, a pain relief medication, can safely reduce mouth pain caused by radiation in people with head and neck cancer. Participants will also take oral tramadol to evaluate its effectiveness in combination with the patch for pain relief. Individuals with cancer in areas such as the mouth or throat who are undergoing radiation treatment might be suitable candidates, particularly if they do not have existing mouth sores or a history of certain medical conditions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in pain management.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot use certain opioids or be on anti-depressant and anti-psychotic therapy. If you're taking these, you may need to stop them before joining.

Is there any evidence suggesting that buprenorphine is likely to be safe for humans?

Research is exploring the safety of a skin patch called transdermal buprenorphine for relieving pain from mouth sores in head and neck cancer patients who have undergone radiation. Previous studies have shown that buprenorphine effectively manages pain. Buprenorphine already has FDA approval for other uses, suggesting it is generally safe when used correctly. However, like all treatments, it can cause side effects. Some patients have experienced nausea, dizziness, and constipation, common with opioids, but these are usually manageable. As this research is still in the middle phase of trials, the safety data appears promising but remains incomplete. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for mucositis?

Unlike the standard treatments for mucositis pain in head and neck cancer patients, which often rely on opioid medications like morphine or hydrocodone, the study drug buprenorphine offers a unique approach. Buprenorphine is administered via a transdermal patch, providing a continuous and controlled release of the medication, which can enhance pain management while potentially reducing side effects associated with oral opioids. Researchers are particularly excited about buprenorphine's dual mechanism of action, as it not only activates opioid receptors to alleviate pain but also acts as a partial agonist, potentially minimizing the risk of dependency. This combination of features positions buprenorphine as a promising alternative for managing radiation-induced mucositis pain.

What evidence suggests that buprenorphine might be an effective treatment for mucositis in head and neck cancer?

Research has shown that buprenorphine, particularly as a skin patch, may help manage pain from oral mucositis, a painful mouth inflammation in head and neck cancer patients. This trial will administer buprenorphine alongside oral tramadol to evaluate its effectiveness in providing adequate analgesia for radiation-induced mucositis pain. Studies have found that opioids like buprenorphine effectively relieve pain from cancer treatments. Early results suggest that this combination can significantly ease pain from radiation-induced mucositis, potentially improving quality of life by reducing the severe pain often experienced during cancer therapy. ^{1 2 3 5 6}

Who Is on the Research Team?

Stuart J. Wong, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04752384

Transdermal Buprenorphine for the Treatment of Radiation ...

This is a single-arm, interventional, supportive care clinical trial for head and neck cancer patients evaluating role of transdermal (TD) buprenorphine and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8184418/

Narrative review of the management of oral mucositis ...

Oral mucositis (OM) can be a significant problem for patients undergoing radiation or chemoradiation for head and neck cancer. In modern clinical trials, grade ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0167814025001264

Opioid therapy vs. Multimodal analgesia in head and neck ...

Most HN cancer patients suffer from significant mucositis during RT or CRT. · This randomized trial compared multimodal analgesia (MMA) to opioid analgesia.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12296661/

Addressing Pain in Oral Mucositis: Narrative Review of ...

Addressing the multifaceted nature of OM-associated pain is essential for enhancing quality of life and optimizing cancer treatment outcomes.

5.

mypcnow.org

mypcnow.org/fast-fact/multimodal-analgesic-strategies-for-cancer-related-oral-mucositis/

Multimodal Analgesic Strategies for Cancer-Related Oral ...

This Fast Fact assimilates the published evidence to offer multimodal analgesic strategies for oral mucositis pain from cancer treatment.

6.

asco.org

asco.org/abstracts-presentations/ABSTRACT277323

Pain management in patients undergoing treatment for ...

Results: 5 patients on buprenorphine and 4 patients on methadone underwent treatment with chemoRT for head and neck cancer. Despite effectiveness for pain ...