Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer

Recruiting

• Conditions: Malignant Solid Neoplasm; Breast Carcinoma; Malignant Thoracic Neoplasm; Kidney Carcinoma
• Interventions: Procedure: Functional Near-Infrared Spectroscopy; Other: Questionnaire Administration; Other: Virtual Technology Intervention

• Registration Number: NCT06456411
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

This study attempts to measure pain severity, location of pain, and feasibility in patients with cancer using functional near-infrared spectroscopy and virtual reality relaxation programs. Functional near-infrared spectroscopy and virtual reality relaxation programs may help relieve pain in patients with cancer who are receiving treatment.

Detailed Description

PRIMARY OBJECTIVES:

I. Develop an algorithm for objective evaluation of pain severity and distinguish the location of pain without needing patient cooperation.

II. Find the relationship between fNIRS (functional near-infrared spectroscopy) features and severity of pain as well as the relationship (if any) between perceived pain severity and visual perception.

SECONDARY OBJECTIVES:

I. Investigate the effect (and the reasoning of the effect) of alleviating severity of perceived pain utilizing virtual reality techniques.

II. Monitor changes of brain activity to find out the reason for pain alleviation caused by virtual reality techniques and/or cognitive distraction.

OUTLINE: Healthy participants are assigned to group A. Cancer patients are randomized to group B or group C.

GROUP A: Participants undergo fNIRS for over 15 minutes.

GROUP B: Patients undergo fNIRS for over 15 minutes followed by a relaxation period using virtual reality (VR) for over 15 minutes.

GROUP C: Patients undergo fNIRS for over 15 minutes.

GROUP D: Patients are randomized to 1 of 2 arm:

ARM I - Patients undergo fNIRS for over 15 minutes followed by a relaxation period using VR for over 15 minutes.

ARM II: Patients undergo fNIRS for over 15 minutes

Study Timeline

• Study Start: 2022-07-12
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-07-12
• Study Completion: 2026-07-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Study participants (cancer patients as well as healthy volunteers) must be over the age of 18
• Study participants (cancer patients as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes
• For cancer participants: in any stage of cancer treatment, such as diagnosis, treatment (surgery, chemotherapy, immunotherapy, radiation), recovery, remission and is experiencing acute pain from treatment. Cancers include but are not limited to: breast, thoracic, kidney, etc.
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

• Unwilling or unable to follow protocol requirements
• Currently pregnant or planning to become pregnant during the study period
• Medical condition predisposing to nausea or dizziness.
• Hypersensitivity to flashing light or motion.
• No stereoscopic vision or severe hearing impairment.
• Unwillingness or inability to follow protocol requirements.
• Individuals with impaired decision-making capacity.
• Individuals with electronic or metallic implants in the head.
• Unable to remove any items from their scalp that might block direct contact between the fNIRS optodes and the skin. This includes, but is not limited to, wigs and hijabs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B (fNIRS, VR)	Questionnaire Administration	Patients undergo fNIRS for over 15 minutes followed by a relaxation period using VR for over 15 minutes.
Group B (fNIRS, VR)	Virtual Technology Intervention	Patients undergo fNIRS for over 15 minutes followed by a relaxation period using VR for over 15 minutes.
Group A (fNIRS)	Functional Near-Infrared Spectroscopy	Participants undergo fNIRS for over 15 minutes.
Group A (fNIRS)	Questionnaire Administration	Participants undergo fNIRS for over 15 minutes.
Group B (fNIRS, VR)	Functional Near-Infrared Spectroscopy	Patients undergo fNIRS for over 15 minutes followed by a relaxation period using VR for over 15 minutes.
Group C (fNIRS)	Questionnaire Administration	Patients undergo fNIRS for over 15 minutes.
Group C (fNIRS)	Functional Near-Infrared Spectroscopy	Patients undergo fNIRS for over 15 minutes.

Primary Outcome Measures

Name	Time	Method
Gain knowledge of Brain activity during pain	Up to 4 years	Computational neuroscience algorithms and graph theories will be used to extract informative patterns of brain activity and diagnose the stimulated brain areas associated with pain and pain severity as well as any relationships between pain severity, functional near-infrared spectroscopy (fNIRS) measures, and visual perception.

Secondary Outcome Measures

Name	Time	Method
Reason for pain alleviation caused by virtual reality techniques	Up to 4 years	Measured by fNIRS and quantified by signal processing and network neuroscience algorithms, to find out the reason for pain alleviation caused by virtual reality techniques. We will also investigate if cognitive distraction can be the main reason.
Determine if utilizing virtual reality technologies significantly alleviate pain through distraction	Up to 4 years	By utilizing virtual reality relaxation program we will analyze brain activity to find out how this distraction is controlled by the brain.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States