Virtual Reality Therapy for Gastrointestinal Cancer Pain

Overseen by Scott Irwin, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Seizures, Visual impairments, Cognitive impairment, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.

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, it does mention that the study will measure opioid use, so you might be able to continue your current pain management medications.

What data supports the effectiveness of the treatment Virtual Reality Therapy for managing pain in gastrointestinal cancer patients?

Research shows that virtual reality (VR) can help reduce pain and anxiety in cancer patients, including those undergoing medical procedures and chemotherapy. Studies have found that VR-based interventions significantly improve symptoms like pain, anxiety, and depression, suggesting it could be a helpful tool for managing cancer-related symptoms. ^{1 2 3 4 5}

Is Virtual Reality Therapy safe for humans?

There is no specific safety data on Virtual Reality Therapy for gastrointestinal cancer pain, but VR therapy has been generally considered safe in other contexts, with some users experiencing mild side effects like dizziness or nausea. ^{6 7 8 9 10}

How is virtual reality treatment different from other treatments for gastrointestinal cancer pain?

Virtual reality treatment is unique because it immerses patients in a multisensory experience to relieve pain, unlike traditional medications that may have side effects or only partially relieve symptoms. This non-drug approach allows patients to self-practice pain management techniques in a standardized way, offering a novel solution for chronic pain management. ^{11 12 13 14 15}

Research Team

Brennan Spiegel, MD, MSHS

Principal Investigator

Cedars-Sinai Medical Center

Scott Irwin, MD, PhD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults with certain types of digestive tract cancers (like colon, liver, or stomach cancer) who are not planning surgery soon and have significant pain. They must be able to read/write in English and score high on a specific pain scale. People can't join if they have seizures, severe visual impairments, cognitive issues that affect understanding the study, brain metastases, or a life expectancy less than 3 months.

Inclusion Criteria

Ability to read and write in English

My cancer type is one of the following: adenocarcinoma, squamous cell, neuroendocrine, or mesenchymal.

My cancer is in the digestive system and surgery isn't planned.

Exclusion Criteria

I don't have seizures, facial injuries, or visual problems that prevent using VR.

I can think and understand well enough to follow study instructions.

My cancer has spread to my brain.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into three groups to receive either skills-based VR therapy, distraction VR therapy, or sham VR for pain management. They will use the VR headset daily for four weeks.

4 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of patient-reported outcomes, opioid use, and other metrics.

60 days

Weekly virtual assessments

Long-term monitoring

Participants continue to be monitored for changes in pain management and quality of life metrics.

Additional 30 days

Treatment Details

Interventions

• Virtual Reality (Behavioural Intervention)

Trial Overview The trial tests how virtual reality (VR) affects patient-reported outcomes like pain levels and opioid use in patients with visceral cancer pain. It compares three groups: one using VR with skills training; another using VR for distraction; and a control group watching 2-D content on VR headsets.

Participant Groups

Group I: Virtual Reality Program B Experimental Treatment 1 Intervention

This arm will include software that provides immersive distraction based content for pain reduction.

Group II: Virtual Reality Program A Experimental Treatment 1 Intervention

This arm will include software that provides immersive skills-based content for pain reduction.

Group III: Virtual Reality Program C Placebo Group 1 Intervention

This arm will include software that provides nonimmersive distraction based content for pain reduction.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

Virtual reality (VR) technology in medicine allows for repeated practice of medical procedures and offers diverse experiences with virtual organs, enhancing both learning and evaluation of clinical skills.

In clinical oncology, VR can simulate surgeries, aid in cancer diagnosis, improve patient education, and even help manage the psychological stress of cancer patients, showcasing its potential in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for palliative medicine. Oyama, H.[2004]

A study involving 14 advanced cancer patients using immersive virtual reality (VR) at home over 4 days showed significant short-term improvements in symptoms like pain, anxiety, and depression immediately after VR sessions, despite no significant changes in overall scores from day one to day four.

The use of VR as a complementary therapy suggests potential benefits for managing psychological and physical symptoms in cancer patients, indicating it could be a valuable tool in palliative care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality in Home Palliative Care: Brief Report on the Effect on Cancer-Related Symptomatology. Moscato, S., Sichi, V., Giannelli, A., et al.[2021]

A systematic review of nine studies on the use of immersive virtual reality (VR) for pain and anxiety management in cancer patients showed a trend towards improvement, but only two studies demonstrated statistically significant results.

The current evidence is inconclusive due to methodological limitations and small sample sizes, highlighting the need for further research to better understand the effectiveness of VR in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. Chow, H., Hon, J., Chua, W., et al.[2021]

The study demonstrated that a 30-minute virtual reality session in an underwater environment significantly reduced pain by 59% and improved relaxation, tension, stress, anxiety, and mood in 20 patients with advanced colorectal cancer, indicating its potential as a non-pharmacological pain management tool.

All participants completed the VR session without significant side effects, showing high satisfaction (83%), which supports the feasibility and safety of using virtual reality for pain relief in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. Kelleher, SA., Fisher, HM., Winger, JG., et al.[2022]

In a study of 94 patients undergoing radiation therapy, the severity of pain remained consistent from the first to the final week of treatment, indicating that pain management may need to be addressed continuously throughout the therapy.

Over half of the patients reported using at least one nonpharmacologic method for pain management, with this usage increasing as treatment progressed, highlighting the importance of alternative approaches alongside traditional pain relief methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy Pain Management: Prevalence of Symptoms and Effectiveness of Treatment Options. Lamba, N., Mahal, BA., Martinez, R., et al.[2020]

Acute gastrointestinal (GI) symptoms, particularly diarrhea and proctitis, peaked during weeks 4-5 of chemoradiation therapy for anal cancer, highlighting the need for close monitoring during this period.

There was a notable discrepancy between patient-reported and clinician-reported symptoms, especially for proctitis, suggesting that incorporating patient-reported outcomes could enhance clinical assessments and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of patient-reported gastrointestinal symptoms and agreement with clinician toxicity assessments in radiation therapy for anal cancer. Tom, A., Bennett, AV., Rothenstein, D., et al.[2020]

Patient-reported adverse event monitoring in early phase cancer trials can provide a more accurate and comprehensive understanding of side effects compared to traditional clinician-led methods, which often underestimate symptoms.

The study involved qualitative interviews with 32 participants, including 16 patients and various clinical staff, highlighting the potential benefits of an electronic reporting system to improve patient safety and data collection in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff. Kennedy, F., Shearsmith, L., Ayres, M., et al.[2021]

Cancer patients, especially those with advanced stages, often experience significant pain that can hinder their treatment and overall quality of life, highlighting the need for effective pain management strategies.

A comprehensive approach to pain management is essential, involving various healthcare professionals and treatments, including medications and supportive therapies, to address both the physical and emotional aspects of pain in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic Pain Management: What Radiation Oncologists Should Know. Skarf, LM., Jones, KF., Meyerson, JL., et al.[2023]

In a pilot study of 25 rectal cancer patients undergoing high dose rate brachytherapy, many reported moderate-to-severe anxiety before the applicator insertion, indicating a significant psychological impact during treatment.

The insertion of the applicator was identified as the most painful part of the procedure, with pain levels significantly increasing during this time, suggesting a need for improved pain management strategies and psychosocial support during this critical moment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The experience of pain and anxiety in rectal cancer patients during high-dose-rate brachytherapy. Néron, S., Perez, S., Benc, R., et al.[2021]

Disorders of gut-brain interaction (DGBIs), such as functional dyspepsia and irritable bowel syndrome (IBS), are common and significantly impact patients' quality of life, highlighting the need for effective treatments.

Recent studies suggest that virtual reality (VR) technology may be a promising novel therapy for alleviating chronic abdominal pain associated with DGBIs, potentially offering a non-invasive alternative to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? Lacy, BE., Cangemi, DJ., Spiegel, BR.[2023]

Active virtual reality (VR) therapy significantly improved symptoms of functional dyspepsia compared to sham VR, with a notable mean difference in symptom severity scores over a 2-week period.

The study found that VR was safe, with only one patient withdrawing due to nonserious adverse effects, suggesting it could be a beneficial treatment option for managing dyspepsia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. Cangemi, DJ., Montenegro, M., Spiegel, BMR., et al.[2023]

The IBS/VR program, designed to help patients with irritable bowel syndrome (IBS) through immersive virtual reality experiences, effectively teaches techniques related to the brain-gut axis and cognitive behavioral therapy.

Patient feedback led to 23 software changes, confirming the program's adaptability and relevance, with thematic saturation achieved after 15 interviews, indicating strong acceptance and potential efficacy of this innovative treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. Spiegel, BMR., Liran, O., Gale, R., et al.[2022]

Vagal nerve stimulation (VNS) is being explored as a promising non-drug treatment for chronic abdominal pain, addressing the need for better management strategies in clinical practice.

The gammaCore stimulator offers a noninvasive method for VNS, potentially normalizing gut-brain signaling to alleviate chronic pain associated with gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive vagal nerve stimulation for gastroenterology pain disorders. Gottfried-Blackmore, A., Habtezion, A., Nguyen, L.[2022]

Chronic pain in the gastrointestinal system can occur without harmful stimuli, making it a primary issue rather than just a symptom, which is important for understanding treatment approaches.

Both spinal and vagal afferents are involved in how we perceive gut pain, with spinal pathways helping us discriminate the pain and vagal pathways influencing emotional responses, suggesting that targeted therapies can be developed to address these different aspects of visceral pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic and clinical aspects of visceral sensation: transmission in the CNS. Bielefeldt, K., Christianson, JA., Davis, BM.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality for palliative medicine. [2004]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality in Home Palliative Care: Brief Report on the Effect on Cancer-Related Symptomatology. [2021]

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

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]

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

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. [2022]

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

Radiation Therapy Pain Management: Prevalence of Symptoms and Effectiveness of Treatment Options. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence of patient-reported gastrointestinal symptoms and agreement with clinician toxicity assessments in radiation therapy for anal cancer. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff. [2021]

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

Pharmacologic Pain Management: What Radiation Oncologists Should Know. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The experience of pain and anxiety in rectal cancer patients during high-dose-rate brachytherapy. [2021]

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

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? [2023]

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

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. [2023]

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

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Noninvasive vagal nerve stimulation for gastroenterology pain disorders. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Basic and clinical aspects of visceral sensation: transmission in the CNS. [2022]