Cancer Pain

Researchers are evaluating the analgesic effect and safety of a mixed reality (MR) based cognitive distraction focus relaxation therapy for patients diagnosed with chronic moderate to severe pain. This multicenter, prospective, single-blind, randomized, and parallel controlled trial aims to assess the impact of a digital chronic pain treatment system using MR technology as part of basic clinical care for chronic pain patients. Participants are assigned to one of two groups: the pain key group receiving mixed reality pain treatment software with MR-based pain scenarios, or a control group exposed to the same content displayed on a 2D TV screen. The study compares these approaches to understand the role of MR technology in managing chronic pain. During the study, participants will be monitored using the Visual Analogue Scale (VAS) to measure pain levels over three days. Researchers will collect data on pain intensity and safety outcomes while participants follow the treatment protocols. The trial runs from October 2023 to June 2025, involving adults aged 18 to 85 years with chronic pain lasting more than three months.

Researchers are investigating treatments for temporomandibular disorders (TMD), which are increasingly common and affect jaw function and cause pain. This study aims to evaluate whether combining manual therapy with vagus nerve stimulation, a nerve linked to pain and jaw function, offers better relief and improved quality of life than manual therapy alone. The study involves 20 participants diagnosed with myogenic TMD, focusing on pain, jaw movement, and distress. Participants are randomly assigned to one of two groups: one receiving manual therapy combined with vagus nerve stimulation and the other receiving only manual therapy. Both groups undergo four physiotherapy sessions, one per week over a month, and are trained to continue treatment exercises at home over two months. The manual therapy includes joint manipulation and soft tissue techniques for the jaw. Throughout the study, an independent evaluator will assess participants monthly using questionnaires to measure chronic pain, jaw function, physical symptoms, range of motion, and distress. The main outcomes are changes in health status and chronic pain after two months. This double-blind, randomized study ensures unbiased results by keeping evaluators unaware of group assignments. Participant involvement spans two months of treatment and assessments.

Researchers are evaluating a decisional support intervention called the University of Rochester-Geriatric Oncology assessment for Acute Myeloid Leukemia (UR-GOAL) in older adults newly diagnosed with acute myeloid leukemia (AML). This randomized controlled trial compares the UR-GOAL intervention to an attention control to see if it improves patient distress, shared decision making, and decisional conflict. The study involves four sites and includes patients aged 60 years and older with a new AML diagnosis who have not yet started cancer-directed treatment. Participants are randomly assigned to one of two groups. In the UR-GOAL intervention arm, patients and their caregivers view an AML educational video, complete a best-worst scaling exercise to identify their priorities, and receive a summary report to review and discuss with healthcare providers during clinic visits. Oncologists receive a report including the patient's geriatric assessment, priorities, and prognosis perception to guide discussions. In the attention control arm, patients and caregivers watch a nutritional video, complete a nutrition questionnaire, and receive related handouts to review. Oncologists receive the completed nutrition questionnaire for review. During the study, participants will complete several assessments including the Distress Thermometer Questionnaire at one month, the Shared Decision Making Questionnaire and Decisional Conflict Scale at two weeks, and observed shared decision making at the start. Researchers will monitor patient distress, decision-making quality, and patient-caregiver-oncologist communication. The study is expected to last through June 2030, with patients and caregivers engaging in educational and assessment activities alongside their usual clinical care.

Researchers are conducting a first-in-human, randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 given at different doses in healthy volunteers and surgical patients. This phase 1 trial includes both single and multiple ascending dose parts and involves healthy and surgical participants aged 18 to 55 years. The study aims to explore TT5's effects, including psychological responses and potential fluid biomarkers. The study consists of three parts: Part A tests single ascending intravenous doses of TT5 in healthy participants across up to five dose levels; Part B evaluates multiple ascending doses over seven days in healthy participants with up to three dose levels; and Part C administers intravenous doses on the same day to surgical patients in up to three dose levels. Both TT5 and placebo (vehicle) are given intravenously, and dosing schedules vary according to the study part. Participants will be monitored for adverse events, vital signs, physical exams, laboratory tests, and psychological responses using tools like the Bond and Lader Visual Analog Scale. Pharmacokinetic measurements will include plasma and urine analysis over specified days. Safety and tolerability will be assessed through day 8 for single doses and day 14 for multiple doses. The total study duration varies by cohort, with close follow-up during and after dosing to evaluate TT5's effects and safety.

Researchers are studying whether the handheld device called Grasp can help reduce pain and distress in children and adolescents aged 8 to 15 during small needle procedures. These procedures include venous puncture, insertion of a peripheral venous catheter, and local anesthesia injections before dental treatment. The study aims to compare the effects of using Grasp during these procedures with standard care to see if it helps improve the experience for young patients. Grasp is a soft silicone ball with pressure sensors that detect squeezes of different strengths and durations. When squeezed, it provides real-time visual and auditory feedback through an iPad application, playing melodies and showing dynamic curves. Participants in the intervention group will squeeze the Grasp ball repeatedly, starting at least 10 seconds before and continuing throughout the needle procedure. The control group will receive standard care without Grasp. In addition to the randomized trial, six children with type 1 diabetes will use Grasp during blood sugar measurements or insulin injections as part of exploratory use. During the study, participants will fill out questionnaires about their pain and distress before and after the procedure, as will their parents or guardians. Some participants at the dental clinic will use Grasp during further dental treatment and complete additional forms afterward. The main measure is self-reported pain immediately after the procedure, with secondary measures including distress reported by both children and parents. The study includes interviews with some participants to explore their experiences, and statistical analyses will assess the impact of using Grasp.

Researchers are evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.

Researchers are investigating a new way to predict severe oropharyngeal mucositis caused by radiation therapy in patients with nasopharyngeal carcinoma (NPC), a cancer common in southern China. The study focuses on a mucosal contouring method based on swallowing-induced breakthrough pain, which showed better prediction results than previous methods. This prospective, multicenter, observational study aims to further evaluate the effectiveness of this new predictive approach. The study observes patients with NPC who are undergoing radical radiotherapy or chemoradiotherapy. Researchers will use the new mucosal delineation method to assess radiation-induced oropharyngeal mucositis by monitoring swallowing-induced breakthrough pain. This method aims to identify patients at high risk for severe mucositis to help guide timely interventions, although no specific treatments are provided within the study. Participants will be monitored throughout the study period, which can last up to three years. Researchers will collect continuous records of mucositis severity and self-reported pain during swallowing. The study measures the accuracy of the predictive model using various statistical tools like AUC, sensitivity, and specificity. Safety and other important predictors of mucositis will also be evaluated, with no additional treatments or interventions required for participants.

Researchers are conducting a multi-center clinical longitudinal study to better understand neuropathic pain by examining patients' brain activity and cognitive function. The study collects detailed data on pain levels, sleep quality, social support, anxiety, depression, and cognitive tasks using various scales and imaging techniques. This observational research aims to track changes in these factors during acute pain episodes in adults aged 18 to 85 years. Participants diagnosed with neuropathic pain will join the study and receive standard care from the pain department while being observed over time. The study includes evaluations using pain scales like the Visual Analogue Scale (VAS) and digital pain grading (NRS), as well as assessments of sleep, anxiety, cognitive function, and brain activity through electroencephalogram (EEG) and near-infrared brain imaging (fNIRS). Follow-up continues up to three months after enrollment to monitor changes. During the study, participants will undergo various assessments including pain scoring, cognitive tests, emotional tasks, and questionnaires on sleep and social support. Brain function will be monitored using EEG and fNIRS. Researchers will evaluate measures such as pain intensity, sleep quality, anxiety and depression levels, and cognitive abilities at one month. Participants' progress will be closely observed throughout the study period, which lasts at least three months post-enrollment.

Ureteric stents and catheters are commonly used to restore urinary drainage in patients with kidney stones or cancers pressing on the ureters. These devices often cause complications like inflammation, pain, and infections, which negatively affect quality of life and increase antibiotic use. Device-associated encrustation and biofilm formation lead to urinary tract infections in more than 90% of cases, causing stent blockages and contributing to antibiotic resistance. This research aims to study a novel ureteric stent designed to reduce these complications and improve patient outcomes, particularly in elderly and oncology patients. The trial evaluates an experimental ureteric stent with specially shaped side-holes that prevent low-flow areas where particles settle, reducing encrustation and biofilm formation. Patients with kidney stones or abdominal/pelvic cancers requiring stents will receive this novel stent instead of a conventional JJ stent. The stent will be removed after 4 weeks for kidney stone patients and after 25 weeks for oncology patients. Recruitment for the oncology group starts after reviewing kidney stone patient results. Additionally, qualitative interviews will be conducted with patients and doctors about their stent experiences. Participants will be monitored from enrolment until stent removal, with assessments of stent failure rates, extent of encrustation and biofilm, clinical outcomes, quality of life, and patient experiences. Questionnaires will be completed 2-3 weeks after stent removal. The study includes multiple visits and data collection to understand the impact of the novel stent. Researchers aim to reduce hospital admissions, improve quality of life, and decrease antibiotic use through this innovative device, with follow-up lasting up to 25 weeks for oncology patients.

Researchers are evaluating the effects of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive function, depression, and pain-related disability in older adults who have mild cognitive impairment or early stage Alzheimer's disease, along with chronic pain and depression. The study compares PATH-Pain to Attention Control Usual Care to see which approach leads to better cognitive, emotional, and functional outcomes in this population. This is a randomized control trial with a focus on real-world application in primary care settings. Participants in the PATH-Pain group receive a total of 14 therapy sessions: eight weekly in-office sessions during the first eight weeks, followed by six monthly phone sessions (three individual and three group) from weeks 9 to 36. The therapy teaches emotion regulation, problem-solving skills, and uses compensatory strategies to help manage memory challenges. A tablet app called WellPATH may be used to support emotion regulation techniques. The control group receives usual medical care from their physicians and additional structured interviews and educational sessions unrelated to cognitive impairment, pain, or depression, plus an educational booklet. During the study, participants undergo assessments at the start and at weeks 5, 9, 24, 36, and 52. These include tests of cognitive function using the Repeatable Battery for the Assessment of Neuropsychological Status, evaluations of depressive symptoms, and measures of pain-related disability. Each therapy session lasts about 50 minutes. Caregiver participation is required, and the study monitors cognitive changes, mood, and pain-related functional abilities over one year. The study aims to evaluate the overall impact of PATH-Pain compared to usual care in this group of older adults.