Virtual Reality for Cancer

Overseen By Michell Kim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Prior radiotherapy, Motion sickness, Epilepsy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

25 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Virtual Reality for Cancer is an effective treatment?

The available research shows that Virtual Reality (VR) is effective in helping cancer patients manage symptoms like anxiety, depression, and pain. A meta-analysis found that VR significantly reduced these symptoms and also helped with cognitive function. Another study compared VR to Guided Imagery and looked at mood changes in cancer patients, suggesting VR can positively impact mood. Additionally, VR has been used to improve the quality of life for breast cancer survivors by reducing psychological distress. Overall, these studies indicate that VR is a promising treatment for managing cancer-related symptoms. ^{1 2 3 4 5}

What safety data exists for Virtual Reality treatments for cancer?

The provided research does not contain specific safety data for Virtual Reality treatments for cancer, such as Virtual Reality Program, Immersive Virtual Reality, VR Relaxation Program, or Virtual Reality Meditation. The studies focus on other areas like REMS, radium-223, antineoplastic medicines, and inpatient safety, but do not address Virtual Reality treatments. ^{6 7 8 9 10}

Is the Virtual Reality Program a promising treatment for cancer?

Yes, the Virtual Reality Program is a promising treatment for cancer. It helps manage symptoms, reduces anxiety, depression, and pain, and improves mood and quality of life for cancer patients. ^{1 2 3 11 12}

What is the purpose of this trial?

The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT).

Research Team

Michael LaRiviere, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for cancer patients who are scheduled to undergo radiation therapy. It's designed to see if using a Virtual Reality (VR) program before the simulation can help them relax.

Inclusion Criteria

I am scheduled for a radiation treatment planning session at PCAM.

I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

I have undergone radiotherapy before.

I have a history of motion sickness, vertigo, epilepsy, seizures, migraines, or light sensitivity.

I am currently experiencing nausea, vomiting, dizziness, or issues with my vision or hearing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-simulation VR Intervention

Participants experience a virtual reality program designed to promote relaxation prior to radiation simulation

11 minutes

1 visit (in-person)

Radiation Simulation

Participants undergo simulation for radiation treatment planning

1 day

1 visit (in-person)

Follow-up

Participants are monitored for anxiety levels and provide feedback on the VR program

12 months

Treatment Details

Interventions

• Virtual Reality Program

Trial Overview The study is testing a VR platform that aims to promote relaxation in patients about to receive radiation therapy. The focus is on determining whether this technology is practical and helpful in a clinical setting.

Participant Groups

Group I: Virtual Reality Program Experimental Treatment 1 Intervention

This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.

Virtual Reality Program is already approved in United States, European Union for the following indications:

Approved in United States as Virtual Reality Program for:

• Anxiety reduction in cancer patients undergoing radiation therapy

Approved in European Union as Immersive Virtual Reality for:

• Pain management and distress reduction in cancer patients

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Findings from Research

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]

In a randomized crossover trial involving 50 cancer patients undergoing chemotherapy, Virtual Reality (VR) significantly improved mood states compared to Guided Imagery (GI), indicating its potential as a beneficial intervention for emotional well-being during treatment.

The VR intervention also led to statistically significant improvements in biophysical parameters like blood pressure and heart rate, although it did not show effectiveness in reducing symptoms of nausea, pain, or feeling sick.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. Ioannou, A., Paikousis, L., Papastavrou, E., et al.[2022]

The VR-CALM intervention significantly reduced psychological distress, anxiety, depression, sleep disorders, and fatigue in 98 breast cancer survivors compared to the usual care group, indicating its effectiveness in managing these symptoms.

Patients in the VR-CALM group also reported a higher quality of life after the intervention, demonstrating that this virtual reality-based therapy can be a beneficial addition to traditional cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of VR-CALM Intervention Based on VR on Psychological Distress and Symptom Management in Breast Cancer Survivors. Zhang, X., Yao, S., Wang, M., et al.[2022]

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 systematic review of 17 studies involving 799 cancer patients found that virtual reality (VR) significantly improved pain, anxiety, upper extremity function, and quality of life after intervention, indicating its efficacy in cancer rehabilitation.

VR not only alleviated physical and psychological symptoms but also showed positive effects on cognitive function, suggesting it can be a valuable addition to comprehensive cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on physical, cognitive, and psychological outcomes in cancer rehabilitation: a systematic review and meta-analysis. Hao, J., Li, Y., Swanson, R., et al.[2023]

The FDA launched the REMS Public Dashboard in December 2021, providing an interactive tool for healthcare providers, patients, and researchers to access and visualize Risk Evaluation and Mitigation Strategy (REMS) information for drugs approved since 2008.

The dashboard allows users to explore various REMS characteristics and trends over time, enhancing public access to important drug safety information and supporting informed decision-making in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities. Toyserkani, GA., Lee, JH., Zhou, EH.[2023]

A study analyzing 4,339 adverse events (AEs) associated with radium-223 from the Eudra-Vigilance database found that the most common AEs were hematological, general, and gastrointestinal disorders, with over 90% classified as serious and 8% fatal.

Older patients (over 85 years) treated with radium-223 showed a higher risk of cardiac, infectious, and metabolic disorders compared to younger patients, indicating the need for careful monitoring in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. Tema, G., Lombardo, R., Voglino, O., et al.[2021]

In a three-month pilot study involving 75 cancer patients, an intensive safety monitoring program identified that 44% experienced adverse drug reactions, with 69.7% of these being serious and 15.2% unexpected.

Trifluridine/tipiracil had the highest toxicity rate at 72.7%, followed by olaparib and trastuzumab emtansine, highlighting the importance of monitoring for adverse effects to enhance patient safety in oncology treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive safety monitoring program of antineoplastic medicines: A pilot study in a Portuguese oncology hospital. Mendes, D., Rigueiro, G., Silva, RS., et al.[2020]

A study involving 52 patients from 2019 to 2021 highlighted the importance of active pharmacovigilance in monitoring adverse drug reactions (ADRs) for oral antineoplastic agents, which are often used despite having limited safety data.

The study found that while hematological disorders were the most common ADRs reported, only four patients discontinued treatment due to toxicity, indicating that the active monitoring model helped in managing adverse events effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring. Carvalho da Silva, SP., Jesus, M., Roque, F., et al.[2023]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

A study involving 123 adults undergoing chemotherapy found that using virtual reality (VR) as a distraction made the treatment feel shorter and was generally well-received, with 82% of participants expressing a desire to use it again.

Despite the positive feedback on the VR experience, the intervention did not significantly reduce symptom distress immediately or two days after chemotherapy, indicating that while VR can enhance the treatment experience, it may not alleviate chemotherapy-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: a distraction intervention for chemotherapy. Schneider, SM., Hood, LE.[2018]

Immersive virtual reality (IVR) significantly reduces anxiety, depression, and fatigue in adult cancer patients undergoing chemotherapy, based on a systematic review of 15 trials with 607 adults.

In pediatric cancer patients, IVR effectively lowers pain and anxiety, indicating its potential as a supportive therapy during chemotherapy for both adults and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of randomized controlled trials on the effectiveness of immersive virtual reality in cancer patients receiving chemotherapy. Gautama, MSN., Huang, TW., Haryani, H.[2023]

References

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

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

2. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. [2022]

3. Egypt pubmed.ncbi.nlm.nih.gov

The Impact of VR-CALM Intervention Based on VR on Psychological Distress and Symptom Management in Breast Cancer Survivors. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality for palliative medicine. [2004]

5. Germany pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on physical, cognitive, and psychological outcomes in cancer rehabilitation: a systematic review and meta-analysis. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. [2021]

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

Intensive safety monitoring program of antineoplastic medicines: A pilot study in a Portuguese oncology hospital. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring. [2023]

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

Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]

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

Virtual reality: a distraction intervention for chemotherapy. [2018]

12. Scotland pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of randomized controlled trials on the effectiveness of immersive virtual reality in cancer patients receiving chemotherapy. [2023]