NCT06456411

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

Real-Time Evaluation of Severity of Perceived Pain in Patients With Cancer by Using Functional Near-Infrared Spectroscopy (fNIRS), and Investigation of Pain Relief Utilizing Virtual Reality Technologies

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to develop objective tools for assessing perceived pain severity in cancer patients and survivors, evaluate the sustained effectiveness of non-pharmacological interventions such as virtual reality in reducing pain and medication use, and create tools for the early detection of neuropathy. Wireless, non-invasive neuroimaging methods, including functional near-infrared spectroscopy (fNIRS), will be used to support these objectives

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 psychological factors. III. Understand the acute cold dysesthesias with oxaliplatin and how this correlated with more chronic neuropathy IV. Investigate the sustained effects of therapeutic virtual reality versus Sham virtual reality on pain severity and medication doses. V. Monitor VR-induced changes of brain activity to find out the underlying mechanisms of pain alleviation. SECONDARY OBJECTIVES: I. Investigate the effect of demographic factors on perceived pain severity and VR-inducated pain alleviation \- Investigate the effects of repeated VR use on doses of medications. OUTLINE: Healthy participants are assigned to group A. Cancer patients are randomized to group B, C , D or E. GROUP A: Participants undergo fNIRS for 10 minutes. GROUP B: Patients undergo fNIRS for 10 minutes followed by a relaxation period using virtual reality (VR) for over 15 minutes. GROUP C: Patients undergo fNIRS for 10 minutes. GROUP D: Patients are randomized to 1 of 2 arm: ARM I - Patients use VR for up to 30 minutes. ARM II: Patients use Sham VR Program for up to 30 minutes GROUP E: Cold pack stimulation on Day 1 of each chemotherapy cycle and day 3.

Conditions

• Breast Carcinoma
• Kidney Carcinoma
• Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Functional Near-Infrared Spectroscopy	Undergo fNIRS
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Virtual Technology Intervention	Undergo relaxation period using VR
OTHER	Cold Stimulation	cold stimulation using ice pack

Timeline

• Start date: 2022-07-12
• Primary completion: 2030-07-12
• Completion: 2030-07-12
• First posted: 2024-06-13
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States