Neurofeedback for Head and Neck Cancer Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antipsychotics

Disqualifiers: CNS disease, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether LORETA Neurofeedback Training can reduce pain caused by radiotherapy in individuals with head and neck cancer. Neurofeedback uses a computer program to help participants learn to change their brain waves, potentially lowering pain levels and improving quality of life. Participants will undergo neurofeedback sessions during their radiotherapy treatment. This trial suits those scheduled for a six-week radiotherapy course for head and neck cancer, who have manageable pain levels before starting treatment, and who can read and understand English. As an unphased trial, this study offers a unique opportunity to explore innovative pain management techniques during radiotherapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not change your type of pain medication during the study. You cannot participate if you are taking antipsychotic medications.

What prior data suggests that neurofeedback training is safe for head and neck cancer patients?

Research has shown that LORETA neurofeedback training might safely manage pain. In a recent study, 14 out of 17 patients reported less pain after the training sessions. Another review suggested that neurofeedback could reduce pain and improve symptoms for people with chronic pain.

While specific information on side effects is lacking, neurofeedback is non-invasive. It doesn't involve surgery or inserting anything into the body, which generally makes it safer. Overall, studies suggest that neurofeedback could be a promising and safe way to manage pain for those receiving radiotherapy for head and neck cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LORETA Neurofeedback Training for head and neck cancer pain because it offers a non-invasive way to manage pain without relying on medications like opioids or NSAIDs, which can have significant side effects. Unlike traditional pain treatments that focus on symptom relief, LORETA Neurofeedback works by retraining the brain's electrical activity to alter pain perception. This innovative approach has the potential to provide relief more quickly and sustainably by addressing the root of the pain experience rather than just masking it.

What evidence suggests that neurofeedback is effective for reducing pain in head and neck cancer patients?

Research has shown that LORETA Neurofeedback Training, included in this trial's supportive care arm, can help reduce pain. One study found that 14 out of 17 patients with head and neck cancer experienced less pain after the training. Other studies suggest that neurofeedback can lower chronic pain and improve related issues. This training alters brain activity, which can change how pain is experienced. It has shown promise in targeting specific brain areas to provide noticeable relief. ^{1 2 3 4 5}

Who Is on the Research Team?

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with head and neck cancer, who are about to start a 6-week radiotherapy course and currently have low pain levels. They must consent to the study's protocol and not plan on changing their pain medication during the study. Those with chronic pain, mental health conditions like bipolar disorder or schizophrenia, seizure disorders, or active brain diseases cannot participate.

Inclusion Criteria

My head or neck pain is 2 or less on a scale of 0 to 10.

I do not plan to change my pain medication during the study.

I am set to start a 6-week radiotherapy for my head or neck cancer.

Exclusion Criteria

I do not have active brain metastases or severe brain disorders.

I am currently taking antipsychotic medication.

I have chronic pain in my head or neck that requires painkillers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Patients undergo radiotherapy as part of their cancer treatment

6 weeks

Neurofeedback Training

Patients undergo neurofeedback training once per day, three times per week for up to 6 treatments

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LORETA Neurofeedback Training

Trial Overview The trial is testing neurofeedback training—a therapy that uses brain wave activity measurements to potentially reduce acute pain caused by radiotherapy in head and neck cancer patients. Participants will learn how to alter their own brain waves to lessen pain perception.

How Is the Trial Designed?

Group I: Supportive care (neurofeedback) Experimental Treatment 2 Interventions

Beginning at weeks 4 and 5 or 5 and 6 of radiotherapy, patients undergo neurofeedback training QID TIW for up to 6 treatments. Patients also complete questionnaires over 10 minutes at baseline and after neurofeedback training.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Neurofeedback is a noninvasive treatment that uses brainwave analysis to help patients with central nervous system issues, especially when traditional therapies like medication and psychotherapy are ineffective.

While there are many clinical case studies supporting the efficacy of neurofeedback, there is still a need for more controlled studies in peer-reviewed journals to further validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. Larsen, S., Sherlin, L.[2013]

A tailored hatha yoga program for head and neck cancer survivors was found to be feasible, with high participant retention and satisfaction, and no adverse events reported during the 8-week intervention.

Preliminary efficacy data suggested that the yoga program may improve shoulder range of motion, reduce pain, and decrease anxiety in participants, indicating potential benefits for managing long-term treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Efficacy of Tailored Yoga in Survivors of Head and Neck Cancer: A Pilot Study. Adair, M., Murphy, B., Yarlagadda, S., et al.[2019]

Both meditation techniques—meditation with a coach and self-meditation with a CD—were effective in reducing anxiety, depression, and emotional distress in patients undergoing radiation therapy for head and neck cancer, as shown in a study of 28 patients over 12 weeks.

Self-meditation with a CD was found to be a more cost-effective option compared to meditation with a coach, making it a practical choice for patients facing high stress during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Types of Meditation on Patients' Psychosocial Responses During Radiation Therapy for Head and Neck Cancer. Boxleitner, G., Jolie, S., Shaffer, D., et al.[2017]

A 6-month study involving 23 female breast cancer survivors showed that EEG biofeedback (neurofeedback) is feasible and can significantly improve cognitive impairment, fatigue, and psychological symptoms associated with postcancer cognitive impairment (PCCI).

Participants experienced strong improvements across multiple measures, including cognitive function and sleep quality, with results maintained even 4 weeks after the neurofeedback training, indicating its potential as a restorative intervention for PCCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of EEG biofeedback on reducing postcancer cognitive impairment. Alvarez, J., Meyer, FL., Granoff, DL., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-7-2012-7c2a3

Neurofeedback for Head and Neck Cancer Pain Fourteen out of seventeen patients reported decreased pain after the training sessions.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7378966/

Neurofeedback for Pain Management: A Systematic Review The findings indicate that NF procedures have the potential for reducing pain and improving other related outcomes in individuals with chronic pain.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/B9780128012918000066

LORETA Z-Score Neurofeedback in Chronic Pain and ... In this chapter, several selected cases of chronic pain and headaches are described with effective delivery of targeted LORETA neurotherapy.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30426267/

Exploratory Study of Low Resolution Electromagnetic ... LFBz can modify brain regions relevant for pain and these changes were associated with self-reported decreases in pain perception. Keywords: ...

5. researchgate.net researchgate.net/publication/328915586_Exploratory_Study_of_Low_Resolution_Electromagnetic_Tomography_LORETA_Real-Time_Z-Score_Feedback_in_the_Treatment_of_Pain_in_Patients_with_Head_and_Neck_Cancer

Exploratory Study of Low Resolution Electromagnetic ... Acute pain from mucositis in patients with head and neck cancer (HNC) undergoing radiation therapy (RT) is common, and may not respond well to ...