Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients with Cancer
This clinical trial attempts to measure pain severity, location of pain, and feasibility in patients with cancer using functional near-infrared spectroscopy and virtual reality relaxation programs. Pain management is defined as the process of providing medical care that alleviates or reduces pain. Due to the pain levels, pain management is highly challenging, and balancing pain is complex as overtreating pain runs the risk of addicting patients to pain medication and undertreating pain, on the other hand, may lead to long-term chronic pain and other complications. Functional near-infrared spectroscopy (fNIRS) is a noninvasive optical imaging technique that measures changes in hemoglobin concentrations (a protein in the blood) within the brain. Virtual reality relaxation programs may lessen the perceived pain in patients with cancer through distraction. Functional near-infrared spectroscopy and virtual reality relaxation programs may help relieve pain in patients with cancer who are receiving treatment.
Inclusion Criteria
- GROUPS A, B, AND C: Cancer patients as well as healthy volunteers must be over the age of 18
- GROUPS A, B, AND C: Study participants in Groups A and C (cancer patients as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes
- GROUPS A, B, AND C: Study participants in Groups B and C: Patient can be in any stage of cancer treatment, such as diagnosis, treatment (surgery, chemotherapy, immunotherapy, radiation), recovery, remission and is experiencing pain from treatment or cancer itself. Cancers include but are not limited to: breast, thoracic, kidney, colon, pancreatic, etc.
- GROUPS A, B, AND C: Participants in Groups B and C must be free from other forms of chronic pain (e.g., rheumatologic pain), must be free from neurologic illnesses (e.g., stroke), and must have no brain metastases which could interfere with brain functions
- GROUPS A, B, AND C: 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
- GROUP D: Men and women of 40-80 years old
- GROUP D: Stage I-III lung cancer survivors who have undergone lung resection and developed persistent post-thoracotomy pain (PPTP)
- GROUP D: Willing to comply with study procedures
- GROUP D: Be able to remain sedentary for 20 minutes during functional near-infrared spectroscopy (fNIRS) data recording sessions, including 10 minutes each for fNIRS system setup and 10 minutes data recording
- GROUP D: Female participants must not be pregnant to participate in this study. During the third trimester, the fetus’s brain is significantly developed and may interact with the mother’s brain. As this study involves recording brain activity using fNIRS, it is necessary to exclude pregnant individuals to ensure the quality of the research data
- GROUP D: Be able 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
- GROUP D: Participants must be free from other forms of chronic pain, e.g., rheumatologic pain
- GROUP D: Participants must be free from neurologic illnesses, e.g., stroke
- GROUP D: Had no brain metastases which could interfere with brain functions
- GROUP D: Participants must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board
- GROUP E: Men and women aged 18 years and older
- GROUP E: Diagnosed with colorectal or pancreatic cancer, scheduled to receive a 14-day cycle of oxaliplatin chemotherapy (oxaliplatin plus infusional fluorouracil regimens). Limiting the study to these patients ensures a more uniform population, reducing variability related to treatment regimens
- GROUP E: Be able to remove any items from their scalp that might block direct contact between the skin and fNIRS optodes. This includes, but is not limited to, wigs and hijabs. Furthermore, individuals with metal implants in the skull due to previous surgeries are not eligible to participate
- GROUP E: Participants must be willing to comply with study procedures
- GROUP E: Participants must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board
- GROUP E: Had brain metastases which could interfere with brain functions
Exclusion Criteria
- GROUPS A, B, AND C: Unwilling or unable to follow protocol requirements
- GROUPS A, B, AND C: Currently pregnant or planning to become pregnant during the study period
- GROUPS A, B, AND C: For Group B: Medical condition predisposing to nausea or dizziness
- GROUPS A, B, AND C: For Group B: Hypersensitivity to flashing light or motion
- GROUPS A, B, AND C: For Groups B: Stereoscopic vision or severe hearing impairment
- GROUPS A, B, AND C: Unwillingness or inability to follow protocol requirements
- GROUPS A, B, AND C: Individuals with impaired decision-making capacity
- GROUPS A, B, AND C: Individuals with electronic or metallic implants in the head
- GROUPS A, B, AND C: 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
- GROUPS A, B, AND C: Prisoners
- GROUP D: Individuals with hypersensitivity to flashing lights or motion. Rationale: Such hypersensitivities can increase the risk of seizures or severe discomfort when exposed to common elements of VR programs, which frequently include rapid visual and motion stimuli
- GROUP D: Individuals with impaired stereoscopic vision or severe hearing impairments. Rationale: VR programs often involve moving objects, flashing lights, and immersive soundscapes. Participants must have sufficient vision and hearing to effectively engage with and safely navigate these environments
- GROUP D: Currently pregnant or planning to become pregnant during the study period
- GROUP D: Unwillingness or inability to follow protocol requirements
- GROUP D: Exclusion of individuals with impaired decision-making capacity. Rationale: Participants must be able to provide informed consent and make decisions regarding their continued participation in the study
- GROUP D: Prisoners
- GROUP D: Individuals with electronic or metallic implants in the head, as these implants may obstruct direct contact between the fNIRS optodes and the skin
- GROUP D: Patients with medical conditions that predispose them to nausea or dizziness. Rationale: To minimize the risk of cybersickness that may be induced by VR programs
- GROUP D: Patients with signs of cancer-related cachexia, specifically those with > 15% unintentional weight loss over the past 6 months or a body mass index (BMI) < 18 will be excluded to ensure safety and data integrity
- GROUP D: Diabetic patients are excluded as they may experience chronic pain differently
- GROUP E: Individuals treated with carboplatin, cisplatin, taxanes, or other platinum-based therapies should be excluded. These treatments are known to cause peripheral neuropathy, and their inclusion could confound the results. To focus specifically on neuropathy caused by oxaliplatin, patients receiving other neurotoxic chemotherapy agents are excluded
- GROUP E: Individuals who underwent other neuropathy-associated chemotherapy treatments will be excluded
- GROUP E: Females who are pregnant or plan to become pregnant during the study period will be excluded. During the third trimester, the fetus's brain is significantly developed and may interact with the mother's brain. As this study involves recording brain activity using functional near-infrared spectroscopy (fNIRS), it is necessary to exclude pregnant individuals to ensure the quality of the research data
- GROUP E: Unwillingness or inability to follow protocol requirements
- GROUP E: Individuals with impaired decision-making capacity. Rationale: Participants must be able to provide informed consent and make decisions regarding their continued participation in the study
- GROUP E: Individuals who are not yet adults (younger than 18 years)
- GROUP E: Prisoners
- GROUP E: Individuals with electronic or metallic implants in the head, as these implants may obstruct direct contact between the skin and fNIRS optodes
- GROUP E: Pre-existing conditions or comorbidities that could interfere with the study, such as: * Severe neurological disorders, neurologic illnesses, e.g., stroke * Peripheral neuropathy unrelated to chemotherapy * Other forms of chronic neuropathy * Diabetic patients will be excluded as those patients may experience different neuropathy and their reactions might skew the results
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06456411.
Locations matching your search criteria
United States
New York
Buffalo
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 (and the reasoning of the effect) of alleviating severity of perceived pain utilizing repeated use of therapeutic virtual reality (VR) versus a sham VR.
V. Monitor changes of brain activity to find out the underlying mechanisms of VR-induced pain alleviation.
SECONDARY OBJECTIVES:
I. Investigating the effect of demographic, socioeconomic, psychological, and clinical factors on perceived pain severity and VR-induced pain alleviation.
II. Investigating effects of repeated VR use on doses of medications (neuropathy and pain medications).
OUTLINE: Healthy participants are assigned to group A. Cancer patients are randomized to group B or group C. Cancer survivors experiencing persistent post-thoracotomy pain are assigned to Group D. Cancer patients scheduled to receive oxaliplatin and assigned to Group E.
GROUP A: Participants undergo fNIRS for over 10 minutes.
GROUP B (CLOSED TO ACCRUAL 09/11/2025): Patients undergo fNIRS for over 10 minutes followed by a relaxation period using virtual reality (VR) for over 15 minutes.
GROUP C: Patients undergo fNIRS for over 10 minutes.
GROUP D: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo fNIRS for over 10 minutes at baseline and week 8 and undergo VR intervention over 10-30 minutes four times per week for 8 weeks in the absence of unacceptable toxicity.
ARM II: Patients undergo fNIRS for over 10 minutes at baseline and week 8 and undergo VR sham intervention over 10-30 minutes four times per week for 8 weeks in the absence of unacceptable toxicity.
GROUP E: Patients undergo cold stimulation and undergo fNIRS for over 10 minutes.
After completion of study intervention, participants are followed up at 3 and 6 months and then 1 year.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorSomayeh Besharat Shafiei
- Primary IDI 1720121
- Secondary IDsNCI-2021-11854
- ClinicalTrials.gov IDNCT06456411