RECRUITING

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

Conditions

Breast Carcinoma Kidney Carcinoma Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-07-12

Study Completion:2026-07-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06456411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Study participants in Group A, B or C (cancer patients as well as healthy volunteers) must be over the age of 18 * Study participants in Groups A, B or C (cancer patients as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes * Study Participants in Group B and C: can be 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, lung, kidney, colon, pancreatic, etc. * 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 * - Participants in Group 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 * Men and women of 40-80 years old * Stage I-III lung cancer survivors who have undergone lung resection and developed persistent post-thoracotomy pain (PPTP) * Willing to comply with study procedures * 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. * Must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board. * 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. * 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. * Must be free from other forms of chronic pain, e.g., rheumatologic pain * Must be free from neurologic illnesses, e.g., stroke * Had no brain metastases which could interfere with brain functions * Men and women aged 18 years and older. * 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. * Participants must be free from other forms of chronic neuropathy * Participants must be free from neurologic illnesses, e.g., stroke * Had no brain metastases which could interfere with brain functions * Diabetic patients will be excluded as those patients may experience different neuropathy and their reactions might skew the results. * Participants must be willing to comply with study procedures. * 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 * 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 * Prisoners * Group B: Exclusion of 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 B: Exclusion of individuals with impaired stereoscopic vision or severe hearing impairments. * Exclusion of 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. * Exclusion of 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. * Currently pregnant or planning to become pregnant during the study period. * Unwillingness or inability to follow protocol requirements. * 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. * Prisoners * Individuals with electronic or metallic implants in the head, as these implants may obstruct direct contact between the fNIRS optodes and the skin. * 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. * Patients with signs of cancer-related cachexia, specifically those with \>15% unintentional weight loss over the past 6 months or a BMI \<18 will be excluded to ensure safety and data integrity. * Diabetic patients are excluded as they may experience chronic pain differently. * For 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. * Individuals who underwent other neuropathy-associated chemotherapy treatments will be excluded. * Diabetic patients will be excluded as those patients may experience neuropathy differently. * Females who are pregnant or plan to become pregnant during the study period will be excluded. * Unwillingness or inability to follow protocol requirements. * 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. * Individuals who are not yet adults (younger than 18 years). * Prisoners. * Individuals with electronic or metallic implants in the head, as these implants may obstruct direct contact between the skin and fNIRS optodes. * Pre-existing conditions or comorbidities that could interfere with the study, such as severe neurological disorders, uncontrolled diabetes, or peripheral neuropathy unrelated to chemotherapy.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Study participants in Group A, B or C (cancer patients as well as healthy volunteers) must be over the age of 18
* Study participants in Groups A, B or C (cancer patients as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes
* Study Participants in Group B and C: can be 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, lung, kidney, colon, pancreatic, etc.
* 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
* - Participants in Group 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
* Men and women of 40-80 years old
* Stage I-III lung cancer survivors who have undergone lung resection and developed persistent post-thoracotomy pain (PPTP)
* Willing to comply with study procedures
* 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.
* Must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board.
* 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.
* 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.
* Must be free from other forms of chronic pain, e.g., rheumatologic pain
* Must be free from neurologic illnesses, e.g., stroke
* Had no brain metastases which could interfere with brain functions
* Men and women aged 18 years and older.
* 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.
* Participants must be free from other forms of chronic neuropathy
* Participants must be free from neurologic illnesses, e.g., stroke
* Had no brain metastases which could interfere with brain functions
* Diabetic patients will be excluded as those patients may experience different neuropathy and their reactions might skew the results.
* Participants must be willing to comply with study procedures.
* 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
* 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
* Prisoners
* Group B: Exclusion of 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 B: Exclusion of individuals with impaired stereoscopic vision or severe hearing impairments.
* Exclusion of 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.
* Exclusion of 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.
* Currently pregnant or planning to become pregnant during the study period.
* Unwillingness or inability to follow protocol requirements.
* 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.
* Prisoners
* Individuals with electronic or metallic implants in the head, as these implants may obstruct direct contact between the fNIRS optodes and the skin.
* 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.
* Patients with signs of cancer-related cachexia, specifically those with \>15% unintentional weight loss over the past 6 months or a BMI \<18 will be excluded to ensure safety and data integrity.
* Diabetic patients are excluded as they may experience chronic pain differently.
* For 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.
* Individuals who underwent other neuropathy-associated chemotherapy treatments will be excluded.
* Diabetic patients will be excluded as those patients may experience neuropathy differently.
* Females who are pregnant or plan to become pregnant during the study period will be excluded.
* Unwillingness or inability to follow protocol requirements.
* 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.
* Individuals who are not yet adults (younger than 18 years).
* Prisoners.
* Individuals with electronic or metallic implants in the head, as these implants may obstruct direct contact between the skin and fNIRS optodes.
* Pre-existing conditions or comorbidities that could interfere with the study, such as severe neurological disorders, uncontrolled diabetes, or peripheral neuropathy unrelated to chemotherapy.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Somayeh B Shafiei

PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

Somayeh B Shafiei, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-12

Study Completion Date2026-07-12

Study Record Updates

Study Start Date2022-07-12

Study Completion Date2026-07-12

Terms related to this study

Additional Relevant MeSH Terms

Breast Carcinoma
Kidney Carcinoma
Carcinoma