Interdisciplinary Interventions for Pain in Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Sriram Yennu

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must be taking: Opioids

Disqualifiers: Impaired cognition, MD Anderson employees

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This phase II trial compares different pain management interventions (standard of care \[SOC\], neurofeedback \[NFB\] training, and compassionate high alert team \[CHAT\]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.

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.

What data supports the effectiveness of the treatment Compassionate High Alert Team (CHAT) for pain in head and neck cancer?

Research shows that managing pain in head and neck cancer patients is crucial for improving their quality of life and treatment outcomes. Multimodal approaches, which include various therapies and medications, are recommended to address the complex pain experienced by these patients. ^{1 2 3 4 5}

Is the interdisciplinary intervention for pain in head and neck cancer safe for humans?

The research articles provided do not contain specific safety data for the interdisciplinary interventions mentioned, such as neurofeedback or biofeedback, in humans. ^{2 3 4 5 6}

How does the Standard of Care treatment for pain in head and neck cancer differ from other treatments?

The Standard of Care for pain in head and neck cancer typically involves a combination of routine pain screening and a multimodal approach, including medications like analgesics (pain relievers), antidepressants, and anticonvulsants, as well as integrative medicine. This approach is unique because it addresses both the physical and psychological aspects of pain, aiming to improve quality of life and treatment compliance. ^{1 2 3 4 5}

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Able to read, write and speak English

Willing to sign written informed consent

Exclusion Criteria

Employees of MD Anderson Cancer Center

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

Trial Timeline

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

Treatment Details

Interventions

• Compassionate High Alert Team (Behavioral Intervention)
• Neurofeedback (Behavioral Intervention)
• Standard of Care (Other)

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.

Participant Groups

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+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of pain among patients with head and neck cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Routine screening for pain combined with a pain treatment protocol in head and neck cancer: a randomised controlled trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Chronic Pain Management in Head and Neck Oncology. [2021]

4. Netherlands 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. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. [2022]

6. United States 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. [2023]