Breast Carcinoma, Carcinoma, Kidney Carcinoma
Conditions
Brief 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.
Interventions
Undergo fNIRS
OTHERQuestionnaire Administration
Ancillary studies
Undergo relaxation period using VR
OTHERCold Stimulation
cold stimulation using ice pack
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
GROUPS A, B and C: * Cancer pts as well as healthy volunteers) must be over the age of 18 * Participants in Groups A or C (cancer pts as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes * Participants in Group 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 acute pain from treatment or cancer itself. Cancers include but are not limited to: breast, thoracic, lung, kidney, colon, pancreatic, etc. * 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 * 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 Inclusion Criteria - GROUP D: * Men and women of 40-80 yrs 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. * 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 * Must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board. Inclusion criteria for Group E: * Men and women aged 18 yrs 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. * 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. * Participants must be willing to comply with study procedures. * Must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board.
Exclusion criteria
- GROUPS A, B and C: * Unwilling or unable to follow protocol requirements * Currently pregnant or planning to become pregnant during the study period FOR GROUP B : * Medical condition predisposing to nausea or dizziness. * Hypersensitivity to flashing light or motion. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gain knowledge of Brain activity during pain | Up to 16 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Determine if utilizing virtual reality technologies significantly alleviate pain through distraction | Up to 16 months | By utilizing virtual reality relaxation program we will analyze brain activity to find out how this distraction is controlled by the brain. |
| Reason for pain alleviation caused by virtual reality techniques | Up to 16 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSomayeh B Shafiei
Roswell Park Cancer Institute
Outcome results
None listed