What side effects are associated with this type of intervention?

Common treatments for leukemia, such as lenalidomide maintenance therapy and chemotherapy agents like vincristine, are associated with several side effects. Lenalidomide can cause neutropenia, thrombocytopenia, and diarrhea, with some patients experiencing severe adverse events. Chemotherapy agents like vincristine can lead to neurotoxicity, including paresthesias and loss of deep tendon reflexes, as well as gastrointestinal issues like constipation. General side effects of chemotherapy for leukemia also include fatigue, nausea, and increased risk of infections due to myelosuppression.

What prior FDA approvals exist?

The FDA has approved various drugs for the treatment of leukemia, including targeted therapies, chemotherapies, and immunotherapies. Notably, many pivotal trials supporting these approvals often use surrogate measures as primary endpoints and may include historical controls, especially in oncology. While the use of Virtual Reality (VR) as a distraction technique is being studied to reduce the need for general anesthesia during procedures like lumbar punctures, it is not a direct treatment for leukemia but rather a supportive measure to improve patient comfort during necessary medical procedures.

What other types of research exist?

Promising alternatives to VR for reducing the need for General Anesthesia in leukemia patients include music therapy, guided imagery, and progressive muscle relaxation. These methods have demonstrated effectiveness in managing anxiety and pain during medical procedures.

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Virtual Reality for Lumbar Puncture Distraction

N/A

Waitlist Available

Led By James Thomas, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lumbar puncture for chemotherapy per leukemia therapy

Pediatric and young adult patients 10-25 years of age

Must not have

Tested positive for COVID-19, or opted out of of COVID-19 testing

Active nausea or vomiting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if VR can help young leukemia patients during certain medical procedures. VR helps by distracting patients with engaging experiences, reducing pain and stress. This could make the procedure safer and less costly.

Who is the study for?

This trial is for children and young adults aged 10-25 with leukemia who need a lumbar puncture for chemotherapy. They must have had a previous LP under general anesthesia, be free of COVID-19, not have seizures or severe nausea, and be considered cognitively suitable to use VR.

What is being tested?

The study is testing if Virtual Reality can replace General Anesthesia as a way to keep patients calm during Lumbar Punctures. It's aimed at seeing if VR can help manage pain and anxiety without the risks associated with anesthesia.

What are the potential side effects?

Virtual Reality may cause discomfort like dizziness or nausea in some individuals. Since it's used instead of General Anesthesia, it avoids potential side effects from those drugs such as allergic reactions or complications from sedation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving chemotherapy through a lumbar puncture for leukemia.

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I am between 10 and 25 years old.

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I have had a lumbar puncture with general anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for COVID-19 or chose not to be tested.

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I am currently experiencing nausea or vomiting.

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I have never had a lumbar puncture with general anesthesia.

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I have a history of seizures.

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I am currently experiencing a headache.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Success of completion of the LP with VR

Secondary study objectives

Child Anxiety Meter-State (CAM-S)

Children's Fear Scale (CFS)

Pain Visual Analogue Scale (Pain VAS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VR for LPExperimental Treatment1 Intervention

The patients in this study will be presented the opportunity to use VR instead of undergo GA for a LP. Patients who agree to undergo an LP with VR will be assessed by a certified child life specialist (CCLS) to determine whether the patient is an appropriate candidate for using VR.The system includes a VR headset with VR software already loaded in to it. The VR software to be used is either a game called "Pebbles the Penguin" or "SpacePups" (Weightless Studios).

Group II: GA for LPActive Control1 Intervention

Patients who decline to undergo an LP with VR will be asked if they would be willing to participate by answering questionnaires specific to their pre procedure anxiety. This will include questionnaires 2 and 3 from above. The investigators will also plan to collect vital sign data if they agree to participate in that capacity.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for leukemia include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but also affects healthy cells, leading to side effects. Targeted therapy focuses on specific molecules involved in cancer cell growth and survival, minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. These treatments are crucial for leukemia patients as they aim to eliminate cancer cells while preserving as much normal function as possible. In the context of reducing the need for general anesthesia, techniques like Virtual Reality (VR) can be used to manage pain and anxiety during procedures, potentially improving patient comfort and outcomes.

PAIDEIA: pacemaker and implanted cardioverter defibrillator management in radiation therapy-a survey by the Young Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).Fighting COVID-19.Lessons Learned From a Randomized Controlled Trial of Short-Course Intravenous Antibiotic Therapy for Erysipelas and Cellulitis of the Lower Limb (Switch Trial).