What side effects are associated with this type of intervention?

Common treatments for cervical cancer, such as brachytherapy, radiotherapy, chemotherapy, and surgery, have various side effects. Brachytherapy and radiotherapy can cause acute pain, fatigue, skin irritation, and gastrointestinal issues like diarrhea. Long-term effects may include vaginal dryness, painful intercourse, and changes in bowel and bladder function. Chemotherapy often leads to nausea, vomiting, hair loss, and increased risk of infection due to lowered blood cell counts. Surgical treatments can result in pain, risk of infection, and potential impacts on sexual function. These side effects can significantly affect the patient's quality of life and may require additional supportive care.

What prior FDA approvals exist?

The FDA has approved various treatments for cervical cancer, including surgery, radiation therapy, chemotherapy, and targeted therapy. While specific approvals for VR distraction techniques in cervical cancer treatment are not detailed, the use of adjunctive therapies to improve patient experience, such as pain and anxiety management, is an emerging area of interest. Techniques like VR distraction are being studied to enhance patient satisfaction and reduce procedural pain and anxiety during treatments like brachytherapy and radiotherapy.

What other types of research exist?

Promising alternatives to VR distraction for reducing pain and anxiety in cervical cancer patients include: 1) Music Therapy: Studies have shown that listening to preferred music can significantly reduce anxiety and discomfort during medical procedures. 2) Mindfulness-Based Stress Reduction (MBSR): MBSR has been effective in improving psychological distress and quality of life in cancer patients. 3) Acupuncture: This has been shown to alleviate pain and improve overall well-being in cancer patients. 4) Hypnosis: Hypnosis has demonstrated benefits in reducing pain and anxiety during various cancer treatments. These alternatives can be considered for integration into treatment plans in 2024.

← Back to Search

Virtual Reality for Cervical Cancer Comfort During Brachytherapy

N/A

Recruiting

Led By Gary Lewis, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

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

Must have

Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy

Be older than 18 years old

Must not have

Known history of elevated intraocular pressure

History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using virtual reality (VR) to distract patients can make brachytherapy for cervical cancer more comfortable. The study will compare patient experiences with and without VR during treatment. The goal is to see if VR can reduce pain and anxiety, making the procedure more tolerable. Virtual reality (VR) has been explored as a non-pharmacological method to manage pain and anxiety in cancer patients, showing potential benefits in various medical contexts.

Who is the study for?

This trial is for women aged 18 or older with a confirmed diagnosis of gynecologic cancer (like cervical cancer) that requires brachytherapy. Participants must be able to give written consent. It's not suitable for those with certain phobias, severe vision or hearing issues, history of seizures or motion sickness due to visual triggers, or any condition that would interfere with wearing a VR headset.

What is being tested?

The study tests if using the Oculus Quest 2 Virtual Reality Headset during brachytherapy can improve patient satisfaction and reduce pain and the need for painkillers or anxiety medication. The goal is also to see how well VR technology fits into the clinical routine.

What are the potential side effects?

While not directly related to treatment side effects, using VR may cause discomfort such as dizziness, nausea, eye strain, headaches in some individuals—especially those prone to motion sickness.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a gynecologic cancer that needs specific radiation therapy.

Exclusion Criteria

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

Select...

I have a history of high eye pressure.

Select...

I have a history of seizures, severe motion sickness, dizziness, or migraines triggered by visual disturbances.

Select...

I do not have claustrophobia, thalassophobia, cleithrophobia, or similar fears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

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

Treatment Details

Study Objectives

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

Secondary study objectives

Benzodiazepine dose

Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety.

Determination of VR distraction during brachytherapy treatment for cervical cancer pain

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Sequence Group DExperimental Treatment1 Intervention

VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.

Group II: Sequence Group CExperimental Treatment1 Intervention

VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.

Group III: Sequence Group BExperimental Treatment1 Intervention

VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.

Group IV: Sequence Group AExperimental Treatment1 Intervention

VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.

0 / 4Eligibility 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

The most common treatments for cervical cancer include surgery, radiation therapy, and chemotherapy. Surgery involves the physical removal of cancerous tissues, which can range from a simple hysterectomy to more extensive procedures depending on the cancer's stage. Radiation therapy uses high-energy rays to target and kill cancer cells, often combined with chemotherapy to enhance its effectiveness. Chemotherapy involves the use of drugs to destroy cancer cells or stop their growth. These treatments are crucial for cervical cancer patients as they directly target and eliminate cancer cells, improving survival rates. The VR distraction technique being studied aims to reduce pain and anxiety during treatments like brachytherapy, a form of internal radiation therapy, thereby potentially improving patient experience and adherence to treatment protocols.

Primary or adjuvant chemoradiotherapy for cervical cancer with intraoperative lymph node metastasis - A review.Digital Self-Management Support Tools in the Care Plan of Patients With Cancer: Review of Randomized Controlled Trials.Streamlining follicular monitoring during controlled ovarian stimulation: a data-driven approach to efficient IVF care in the new era of social distancing.