Interdisciplinary Interventions for Pain in Head and Neck Cancer

Overseen By Sriram Yennu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Opioids

Disqualifiers: Impaired cognition, MD Anderson employees

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 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10-12 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage pain for people with head and neck cancer who might risk misusing opioids. Researchers are testing three approaches: the usual care provided in clinics, neurofeedback (a technique that helps patients reduce pain by changing their brain waves), and the Compassionate High Alert Team (CHAT), a special support program offering counseling and family support. The goal is to determine which method best manages pain and potentially reduces the need for opioids. People with head and neck cancer scheduled for radiation therapy and with a history of non-medical opioid use might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since it involves pain management and opioid use, it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Compassionate High Alert Team (CHAT) approach is generally safe and manageable for most people. In one study, most patients using CHAT improved their opioid use management and experienced less pain over time. Notably, they used fewer opioids without worsening their pain.

For the neurofeedback (NFB) approach, studies also show it is safe. Neurofeedback can help manage pain and improve quality of life. In past research, some cancer survivors using NFB reported feeling less pain and experiencing fewer issues like tiredness and trouble thinking clearly.

Both CHAT and NFB have demonstrated safety. For those considering joining a trial with these treatments, evidence suggests they are generally well-tolerated and could help manage pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these interventions for pain management in head and neck cancer because they offer innovative approaches beyond standard care. The CHAT counseling intervention provides personalized support, engaging patients in 45-60 minute sessions twice a month, which could enhance emotional well-being and pain management over 12 weeks. The NFB intervention stands out by using neurofeedback techniques, engaging patients in 20-30 minute sessions twice a week for up to 10 weeks, potentially offering faster and more targeted pain relief. These methods aim to address pain through psychological and neurological pathways, promising a more holistic approach to pain management compared to traditional options.

What evidence suggests that this trial's treatments could be effective for pain management in head and neck cancer?

In this trial, participants will join different treatment arms to evaluate pain management strategies for head and neck cancer. Research has shown that the Compassionate High Alert Team (CHAT) approach, which participants in one arm may receive, can reduce opioid use in cancer patients without increasing their pain. Studies have found that this method helps control pain and lowers the risk of using opioids for non-medical reasons. Another arm will involve neurofeedback (NFB), which evidence suggests can lessen pain and improve other outcomes for people with chronic pain. Specifically, in patients with head and neck cancer, NFB has reduced pain from treatments like radiotherapy. Both methods aim to manage pain while reducing the need for opioids, offering promising options for those at risk of inappropriate opioid use. ^{1 2 4 6 7}

Who Is on the Research Team?

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with head and neck cancer, scheduled for radiation therapy, who can visit the outpatient center and have a life expectancy of at least one year. Participants must be able to understand English, complete assessments, consent in writing, and currently use opioids. It's not for those with impaired cognition or employees of MD Anderson Cancer Center.

Inclusion Criteria

My condition is either HPV positive or negative.

Willing to sign written informed consent

History of use of non-medical opioid use (SOAPP >= 7+ and/or CAGE >= 2+)

Exclusion Criteria

Employees of MD Anderson Cancer Center

Individual with clinically evident impaired cognition by MDAS score of >= 13

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CHAT, NFB, or SOC interventions. CHAT involves counseling twice a month for up to 12 weeks, NFB involves sessions twice a week for up to 10 weeks, and SOC involves 2-3 sessions per month for up to 12 weeks.

10-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the frequency of NMOU behaviors and pain severity.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Compassionate High Alert Team
• Neurofeedback
• Standard of Care

Trial Overview The study compares standard pain management care with two interventions: neurofeedback training using EEG to potentially reduce pain by altering brain waves; and CHAT which includes comprehensive support on symptom management and opioid safety.

How Is the Trial Designed?

Group I: ARM II (NFB) Experimental Treatment 3 Interventions

Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.

Group II: ARM I (CHAT) Experimental Treatment 2 Interventions

Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.

Group III: ARM III (SOC) Active Control 2 Interventions

Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The treatment for locally-advanced head and neck cancer is very intense and can lead to severe side effects like pain, mucositis, and nutritional issues, which significantly affect patients' quality of life.

A group of Italian experts has recognized the need for better strategies to manage these side effects, particularly pain, to maintain effective treatment intensity and improve overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The vicious circle of treatment-induced toxicities in locally advanced head and neck cancer and the impact on treatment intensity. Bossi, P., Cossu Rocca, M., Corvò, R., et al.[2018]

In a study of 374 patients with head and neck cancer, the average bodily pain score improved from 61 at diagnosis to 65 one year later, indicating some recovery, but still below the population norm of 75.

Key predictors of persistent pain included pre-treatment pain levels, neck dissection, xerostomia (dry mouth), and depressive symptoms, suggesting that targeted pain management and addressing these factors could enhance patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of pain among patients with head and neck cancer. Shuman, AG., Terrell, JE., Light, E., et al.[2021]

Patients with head and neck cancer commonly experience chronic pain, making it essential for healthcare providers to recognize and address these pain syndromes effectively.

A multimodal approach to treating chronic pain is recommended, which includes analgesic medications, adjuvant therapies like antidepressants and anticonvulsants, interventional techniques, and integrative medicine strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Pain Management in Head and Neck Oncology. Blasco, MA., Cordero, J., Dundar, Y.[2021]

Pain from head and neck cancer, primarily caused by oral mucositis due to chemotherapy and radiation, affects 80% of patients and significantly reduces their quality of life by making it difficult to speak, eat, and swallow.

A consensus of 30 statements on pain management was developed by a multidisciplinary group of specialists, highlighting the need for better recognition and treatment of pain in head and neck cancer patients to improve treatment compliance and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. Mirabile, A., Airoldi, M., Ripamonti, C., et al.[2022]

In a study involving 156 head and neck cancer patients, both a pain treatment protocol and usual care led to a reduction in pain severity over three months, but there was no significant difference in pain levels between the two groups.

The intervention group showed significant improvements in the Pain Management Index and patient satisfaction compared to usual care, although the intervention was more expensive and had a low likelihood of being cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine screening for pain combined with a pain treatment protocol in head and neck cancer: a randomised controlled trial. Williams, JE., Peacock, J., Gubbay, AN., et al.[2018]

In a study of 2,331 head and neck cancer patients, 36.76% reported pain, with White patients experiencing longer resolution times for pain incidents compared to non-White patients (99.6 minutes vs. 74.9 minutes).

White patients were significantly more likely to receive new pain prescriptions than non-White patients, highlighting disparities in pain management that could affect the quality of life for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sociodemographic Differences in Patient-Reported Pain and Pain Management of Patients With Head and Neck Cancer in a Community Oncology Setting. Canick, JE., Bhardwaj, A., Patel, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5813743/

Outcomes of a Specialized Interdisciplinary Approach for ... The intervention was associated with a reduction in the frequency of AB and opioid utilization among patients with cancer receiving chronic opioid therapy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10304363/

Interdisciplinary intervention for the management of ... The authors developed the Compassionate High-Alert Team (CHAT) intervention to manage patients receiving opioids for cancer pain who demonstrate NMOU behavior.

3. withpower.com withpower.com/trial/phase-3-head-and-neck-neoplasms-9-2021-0122c?fbclid=IwZXh0bgNhZW0CMTEAAR71AlpfrlSuQVZ283xYmCwno0ONv5dTYcLGO4SnqA1AEUv3ExHu5igPF8QD6g_aem_0warEr_2J2vPBdgHuerDHQ

Interdisciplinary Interventions for Pain in Head and Neck ... What data supports the effectiveness of the treatment Compassionate High Alert Team (CHAT) for pain in head and neck cancer? Research shows that managing ...

4. targetedonc.com targetedonc.com/view/multimodal-approach-considered-to-relieve-opioidabuse-crisis

Multimodal Approach Considered to Relieve Opioid Abuse ... In support of this claim, a recent study evaluated the outcomes of effective interventions towards opioid-abuse behaviors. 3While further research is needed, ...

5. ascopubs.org ascopubs.org/doi/10.1200/EDBK_100020

Pain Management for Patients With Advanced Cancer in ... The use of the Compassionate High-Alert Team intervention resulted in a significant decrease in patients' opioid use without a worsening in pain ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05077072?tab=table

Interdisciplinary Interventions to Address Pain Management ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35997289/

Interdisciplinary intervention for the management of ... Most patients who received the CHAT intervention improved in their NMOU behaviors and pain intensity scores 3 and 6 months post-intervention ...