Virtual Reality Therapy for Gastrointestinal Cancer Pain

Overseen By Samuel Eberlein, MSHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Seizures, Visual impairments, Cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) therapy can help manage severe abdominal pain in people with digestive tract cancers. The researchers are testing different types of VR experiences: one group will use skills-based VR, another will use distraction-based VR, and a third will use a basic 2-D VR setup. By comparing these groups, the study aims to determine which VR method most effectively reduces pain and possibly lowers the need for pain medication. Individuals experiencing significant abdominal pain from cancers such as liver, stomach, or colon cancer and who can use VR technology might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative pain management options through VR therapy.

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 prior data suggests that this virtual reality therapy is safe for gastrointestinal cancer pain?

Research has shown that virtual reality (VR) therapy is generally safe for managing cancer pain. Studies have found that VR treatments can significantly reduce pain levels in cancer patients without causing serious side effects. Users report that VR is easy to handle, with only minor issues like dizziness or nausea sometimes occurring. These side effects are usually mild and resolve quickly.

VR therapy involves wearing goggles that create a 3D world, which can help distract patients from pain or teach them ways to manage it better. Both distraction-based and skills-based VR have shown promise in reducing pain. Overall, current research supports the safety of VR therapy for managing cancer pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual reality (VR) therapy for gastrointestinal cancer pain because it offers a novel way to manage discomfort without medication. Unlike traditional treatments like opioids or NSAIDs, which can have significant side effects, VR uses immersive technology to distract and engage patients, potentially reducing pain perception. There are two experimental VR programs being explored: one offers immersive distraction content, while the other provides immersive skills-based content, each aiming to alleviate pain through different interactive experiences. This non-drug approach could revolutionize pain management, providing a safer, side-effect-free alternative for patients.

What evidence suggests that this trial's virtual reality treatments could be effective for gastrointestinal cancer pain?

Research has shown that virtual reality (VR) can greatly reduce pain in cancer patients. It provides a non-drug method to manage pain by distracting patients and teaching skills like meditation. Studies have found that VR lowers anxiety, depression, and distress in cancer patients, with particular effectiveness for pain related to gastrointestinal cancers. This trial examines two types of VR: one group will use immersive distraction-based content, while another will use immersive skills-based content to reduce pain. Both types showed promise in earlier trials for reducing pain and improving quality of life. ^{1 3 6 7 8}

Who Is on the Research Team?

Brennan Spiegel, MD, MSHS

Principal Investigator

Cedars-Sinai Medical Center

Scott Irwin, MD, PhD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

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.

How Is the Trial Designed?

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.

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Virtual reality (VR) interventions have been shown to significantly reduce symptoms of anxiety, depression, pain, and fatigue in cancer patients, based on a meta-analysis of 6 studies.

The findings suggest that while VR is effective for managing acute symptoms during cancer treatment, further research is needed to explore its benefits for long-term side effects in cancer survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. Zeng, Y., Zhang, JE., Cheng, ASK., et al.[2020]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04907643

Virtual Reality for GI Cancer Pain to Improve Patient ... Evidence shows that VR can reduce pain through many different mechanisms. Research shows that VR can also help train people in new skills, such as to meditate, ...

2. reporter.nih.gov reporter.nih.gov/project-details/10891368

Randomized Controlled Trial of Virtual Reality for GI ... This study will test the impact of therapeutic virtual reality (VR)—an evidence-based treatment for pain—as a non-pharmacologic adjunctive treatment for cancer ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-07066

Virtual Reality for GI Cancer Pain to Improve Patient ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12338295/

Effect of virtual reality on pain in oncology patients Meta-analyses have demonstrated that VR-based interventions significantly reduce pain intensity in cancer patients compared to conventional ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0885392423000532

Review Article Effectiveness of Virtual Reality in Symptom ... The results showed that VR-based interventions were statistically effective in improving anxiety, pain, depression, fear, and distress in cancer patients. Our ...

6. uclahealth.org uclahealth.org/clinical-trials/virtual-reality-gi-cancer-pain-improve-patient-reported

Virtual Reality for GI Cancer Pain to Improve Patient ... 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 ...

7. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct04907643

Virtual Reality for GI Cancer Pain to Improve Patient Reported ... 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 ...

8. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/IIT2021-05-SPIEGEL-VR

CSMC, IIT2021-05-SPIEGEL-VR, Ph2, double blind ... To assess the clinical benefits of immersive VR, including skills-based VR and distraction VR, each compared to sham VR among patients with visceral pain.