Virtual Reality for Acute Lymphoblastic Leukemia

(VIRALL Trial)

Recruiting at 1 trial location

Overseen By Alissa Groisser, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Relapsed, Refractory, Ultrasound guided, 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: 20

Duration: Approximately 20 procedures over the course of treatment

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality (VR) can help manage pain and anxiety during spinal taps for children and adolescents with acute lymphoblastic leukemia (ALL), potentially replacing general anesthesia. The VR approach combines a headset for an immersive experience with local anesthesia and optional anti-anxiety medication. This method could serve as a safer alternative to general anesthesia, which has been linked to long-term brain function issues. Children aged 7 and older, in the maintenance phase of their ALL treatment with two cycles remaining, may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques that could enhance the quality of life for young patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the focus is on using virtual reality instead of general anesthesia, it seems unlikely that you would need to stop other medications.

What prior data suggests that virtual reality is safe for managing pain and anxiety in children with acute lymphoblastic leukemia?

Research has shown that virtual reality (VR) in medical settings can be safe and beneficial. For children with acute lymphoblastic leukemia (ALL), VR has improved balance and movement, indicating it can assist without causing harm.

While specific safety data for VR use during spinal procedures in ALL is lacking, it has been safely applied in other cancer treatments. This suggests it could safely manage pain and anxiety during spinal taps. VR might also reduce the need for general anesthesia, which can impact brain function over time.

Overall, VR appears to be a well-tolerated option for helping children feel more comfortable during medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for managing pain and anxiety in children with acute lymphoblastic leukemia because it offers a non-invasive alternative to general anesthesia, which is the standard of care. Unlike traditional methods that rely heavily on drugs like propofol, VR immerses patients in a calming virtual environment, potentially reducing the need for medication. This innovative approach could minimize side effects associated with anesthesia and provide a more engaging, less stressful experience for young patients during procedures.

What evidence suggests that virtual reality is effective for managing pain and anxiety in children with acute lymphoblastic leukemia?

Studies have shown that virtual reality (VR) can effectively reduce anxiety and pain in children undergoing medical procedures. In this trial, one group of participants will receive VR therapy to manage discomfort during lumbar punctures, a procedure to collect spinal fluid, by providing an engaging distraction. Research indicates that VR can serve as a non-medical tool to reduce the need for general anesthesia, which may cause long-term side effects like problems with brain function. Additionally, VR has improved balance and movement in children with acute lymphoblastic leukemia (ALL), suggesting wider health benefits. These findings support VR's potential as a safe and effective alternative for managing the stress of medical treatments in children with ALL. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children and adolescents over 7 years old with acute lymphoblastic leukemia (ALL) who are in the maintenance phase of treatment. They must be scheduled to receive spinal taps as part of their therapy but cannot participate if they have conditions that make VR use unsafe or have had previous adverse reactions to local anesthesia or anti-anxiety medications.

Inclusion Criteria

My initial diagnosis was either ALL or Lymphoma.

I am currently in the maintenance phase of my treatment.

I have 2 more maintenance treatments left.

Exclusion Criteria

My condition has returned or didn't respond to treatment.

Already does LPs without anesthesia

I have had an ultrasound-guided lumbar puncture before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intrathecal chemotherapy with pain and anxiety management using VR, local anesthesia, and optional anxiolytics during lumbar punctures

Approximately 20 procedures over the course of treatment

20 visits (in-person)

Follow-up

Participants are monitored for feasibility and acceptability of VR as an alternative to general anesthesia

1-3 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview The study is testing whether using a Virtual Reality headset, along with local anesthesia and optional anti-anxiety medication, can effectively manage pain and anxiety during spinal taps, as an alternative to general anesthesia.

How Is the Trial Designed?

Group I: VR Arm Experimental Treatment 1 Intervention

Pain and anxiety management in this arm will include: topical numbing cream 30 minutes prior to the scheduled procedure, option for a 0.05mg/kg (max 2 mg) oral/IV dose of lorazepam. VR headsets will be donned. After sterile cleaning of the lumbar spine area, lidocaine will be injected between L3-4 or L4-5 for local anesthetic. A 22-gauge needle of appropriate length (1.5, 2.5, 3.5 inch) will be used to access the intrathecal space. Cerebral spinal fluid will be collected for evaluation (standard procedure) and IT chemotherapy will be administered.

Group II: GA Arm Active Control 1 Intervention

Pain and anxiety in this arm will be managed with general anesthesia, usually propofol, which is the current standard of care at Children's National Hospital.

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?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Rally Foundation for Childhood Cancer Research

Collaborator

Trials

6

Recruited

500+

Rally Foundation for Childhood Cancer Research

Collaborator

Trials

6

Recruited

500+

Published Research Related to This Trial

Recent advancements in treating acute lymphoblastic leukemia (ALL) include new targeted therapies, particularly in immunotherapy, which are changing the treatment landscape.

Innovative approaches such as antibody-based therapies (including monoclonal antibodies and CAR T cells) are being developed, especially for specific subtypes of ALL, indicating a shift away from traditional chemotherapy towards more personalized treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Therapies in Acute Lymphoblastic Leukemia. Phelan, KW., Advani, AS.[2022]

Acute lymphoblastic leukemia (ALL) can be cured in about one third of adult patients, but treatment outcomes vary widely due to individual clinical and genetic factors, which help determine risk classes for tailored therapies.

Modern treatment approaches, including chemotherapy, stem-cell transplantation, and targeted therapies, are improving long-term survival rates for ALL, with ongoing studies aiming for a cure rate of 50% or more.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern therapy of acute lymphoblastic leukemia. Bassan, R., Hoelzer, D.[2022]

A study involving 281 children with acute lymphoblastic leukemia (ALL) showed significant impairments in health-related quality of life (HR-QoL) during the first year of chemotherapy, as reported by both parents and children.

Children receiving intramuscular asparaginase experienced greater treatment and procedural anxiety compared to those receiving intravenous asparaginase, highlighting the impact of treatment type on HR-QoL, particularly during intensive therapy phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impairment of health-related quality of life for children with acute lymphoblastic leukemia over the first year of therapy: A report from the DFCI ALL Consortium. Welch, JJG., Flamand, Y., Stevenson, KE., et al.[2023]

A study involving 90 pediatric oncology patients and their caregivers found that an Immersive VR therapeutic intervention was highly acceptable and satisfactory, with minimal adverse effects reported by patients.

Healthcare professionals expressed favorable perceptions of the VR technology, indicating it was easy to use and useful, suggesting strong potential for future implementation in pediatric oncology settings to improve patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Clinical Implementation of an Immersive Virtual Reality Intervention to Address Psychological Well-Being in Children and Adolescents With Cancer. Tennant, M., McGillivray, J., Youssef, GJ., et al.[2021]

Virtual reality interventions significantly reduce pain and anxiety in children and adolescents undergoing cancer treatment, with medium effect sizes of 0.60 for anxiety and -0.667 for pain based on a meta-analysis of seven randomized controlled trials.

Age was identified as an important factor influencing the effectiveness of virtual reality for pain management, highlighting the need for further large-scale randomized controlled trials to strengthen the evidence for its use in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality in Anxiety and Pain Management in Children and Adolescents Receiving Cancer Treatment: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ozturk, CS., Toruner, EK.[2023]

Virtual reality (VR) technologies have been found to effectively reduce pain, pulse rates, and distress in pediatric cancer patients during invasive treatments, highlighting its potential as a supportive care tool.

The effectiveness of VR is enhanced by high-fidelity features and personalized experiences, suggesting that tailored VR applications could improve patient comfort and pain management during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of virtual reality in the supportive care management of paediatric patients with cancer. Yap, KY., Koh, DWH., Lee, VSJ., et al.[2021]

Acute lymphoblastic leukemia (ALL) is very responsive to initial chemotherapy, but adult long-term survival rates remain low at under 35% due to high relapse rates, highlighting the need for effective post-remission therapies.

Allogeneic donor stem cell transplantation, particularly using unrelated donor (URD) and umbilical cord blood (UCB) allografts, has shown promise in providing an anti-leukemia effect and improving survival outcomes for patients in their first complete remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unrelated donor allogeneic transplantation for adult acute lymphoblastic leukemia: a review. Bachanova, V., Weisdorf, D.[2008]

Recent advancements in treatment for acute lymphoblastic leukemia (ALL) have significantly improved outcomes, especially for older adults and patients with relapsed or refractory disease, through the introduction of novel therapies.

Emerging treatments include targeted tyrosine kinase inhibitors, immune-based therapies like blinatumomab and inotuzumab ozogamicin, and CAR T cell therapies, which are reshaping the treatment landscape and offering new options at diagnosis and during salvage therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Therapies in the Treatment of Adult Acute Lymphoblastic Leukemia. Gavralidis, A., Brunner, AM.[2022]

A case of isolated ovarian relapse of acute lymphoblastic leukemia occurred 7 years after initial treatment, highlighting the potential for late relapses even in patients who appear to be in remission.

The standard treatment for such relapses involves surgical removal of the ovarian mass followed by chemotherapy, which is consistent with approaches for other types of relapses in this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolated ovarian relapse of pre-B acute lymphoblastic leukemia: a case report. Berretta, R., Barone, A., Rolla, M., et al.[2009]

A study involving 257 children and adolescents with leukemia and lymphoma revealed that fatigue was the most severe adverse event reported both before and after treatment, affecting 68.1% of participants at the start and 67% after treatment.

Gastrointestinal symptoms, such as nausea and abdominal pain, were also prevalent, with little change in severity or interference over time, indicating that despite supportive care, many children continue to experience significant symptoms during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal use of patient reported outcomes in pediatric leukemia and lymphoma reveals clinically relevant symptomatic adverse events. Jacobs, SS., Withycombe, JS., Castellino, SM., et al.[2022]

In a study involving 34 children aged 10-15 years in long-term remission from acute lymphoblastic leukemia, combined rehabilitation including balneotherapy showed positive effects on heart rate and circulation asymmetry.

The treatment was found to be safe, with no reported side effects, indicating its potential as a beneficial adjunct therapy for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience in using hydrotherapy in children with acute lymphoblastic leukemia at a sanatorium]. Filippov, EG., Bukhny, AF., Finogenova, NA., et al.[2007]

CD19-directed CAR-T cell therapy has shown a remarkable complete remission rate of 94% in patients with refractory/relapsed B-cell acute lymphoblastic leukemia (ALL), significantly outperforming traditional chemotherapy.

Despite its high efficacy, CAR-T therapy is associated with serious complications such as cytokine release syndrome and neurotoxicity, which pose challenges for its clinical application and are linked to high relapse rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances of CD19-directed chimeric antigen receptor-modified T cells in refractory/relapsed acute lymphoblastic leukemia. Wei, G., Ding, L., Wang, J., et al.[2023]

Acute lymphocytic leukemia (ALL) in children, once a fatal disease, is now curable in nearly half of cases due to extensive research and treatment advancements at St. Jude Children's Research Hospital since 1962.

While survival rates have improved, there is a need to identify 'high-risk' patients who may not respond well to standard treatments, prompting ongoing research to modify therapies for better outcomes while managing long-term treatment-related toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood acute lymphocytic leukemia: progress and problems in treatment. Bowman, WP.[2018]

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 involving 14 children aged 6 to 18 with acute lymphoblastic leukemia (ALL) demonstrated that virtual reality (VR) technology can effectively reduce perceived pain during L-asparaginase (L-ASP) intramuscular injections, with 8 out of 14 patients reporting less pain after using VR.

Caregivers observed that VR not only improved the children's pain perception but also led to less resistance and crying during the procedure, suggesting that VR can enhance the overall experience of painful treatments in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality to Distract From Pain in Children Treated With L-asparaginase by Intramuscular Injection. Chiu, CC., Lin, YT., Wang, Y., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06722638

Virtual Reality During Lumbar Punctures in Acute ... Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10985350/

Virtual reality as a non-medical tool in the treatment of anxiety ... Our aim was to determine the effectiveness of virtual reality in reducing anxiety and pain in patients between 9 and 12 years old in the ...

3. journals.lww.com journals.lww.com/indianjcancer/fulltext/2024/61010/effectiveness_of_a_smartphone_based_virtual.30.aspx

Effectiveness of a smartphone-based virtual reality... The study concluded that a 2-week smartphone-based VR intervention is effective in improving balance and functional mobility in children with ALL.

4. withpower.com withpower.com/trial/phase-leukemia-7-2024-f1712

Virtual Reality for Acute Lymphoblastic Leukemia Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that ...

5. researchgate.net researchgate.net/publication/363923138_Evaluation_the_effectiveness_of_immersive_VR-assisted_rehabilitation_in_a_child_with_chemotherapy-induced_neurological_complication_in_acute_lymphoblastic_leukemia

Evaluation the effectiveness of immersive VR-assisted ... Results of evaluation of neurometabolic and rehabilitation therapy for vincristine polyneuropathy in children with acute lymphoblastic leukemia.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10928524/

Virtual Reality–Based Exercise Rehabilitation in Cancer ... Using these models and devices, VRER was mostly applied in patients with breast cancer (14/25, 56%), leukemia (8/25, 32%), and lung cancer (3/25, 12%).

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/558615

Virtual Reality During Lumbar Punctures in Acute ... Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term.