Clinical trial NCT06456411: Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Kidney Carcinoma
Malignant Solid Neoplasm
Malignant Thoracic Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with pain and healthy participants without pain.

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

Eligibility criteria: 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

Primary outcomes:
measure: Gain knowledge of Brain activity during pain
timeFrame: Up to 4 years
Secondary outcomes:
measure: Determine if utilizing virtual reality technologies significantly alleviate pain through distraction
timeFrame: Up to 4 years
measure: Reason for pain alleviation caused by virtual reality techniques
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Somayeh B Shafiei
role: PRINCIPAL_INVESTIGATOR
References: