Sickle Cell Pain: Intervention With Capsaicin Exposure (SPICE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03899246|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2019
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain Sickle Cell Disease||Drug: Eight Percent Topical Capsaicin||Phase 1|
Patients with sickle cell disease suffer debilitating painful episodes, as well as chronic, often daily, pain that are commonly treated with non-steroidal anti-inflammatory drugs, opioids, and other non-pharmacologic supportive measures. Neuropathic pain has been shown to be present in these patients, with frequency increasing with age. It is believed, based on knowledge of neuropathic pain related to other conditions and from the small number of studies in sickle cell patients, to result from repeated vaso-occlusive pain episodes that prime central and peripheral pain sensing pathways in a maladaptive manner, leading to hyper-sensitization. Very few studies to date have evaluated therapies specifically targeting this aspect of the pain experienced by patients with sickle cell disease.
This is a pilot study for a future longitudinal study of neuropathic pain in pediatric patients with sickle cell disease. The first aim of this pilot study is to establish the safety of treating participants with sickle cell disease aged fourteen to twenty-one with eight percent topical capsaicin patches on an every three-month dosing schedule as recommended by the manufacturer. This will be a single-arm safety study. Presence of neuropathic pain will be determined by day zero evaluation via the testing shown in the outcome measures below. Topical medication will be administered over one hour, every three months, for six months (total of three applications), to sites of recurrent vaso-occlusive pain, according to the package insert administration guidelines. Subjective and objective evaluations of pain and inflammation including questionnaires, blood tests, and quantitative sensory testing will be carried out every six weeks throughout the study period until twelve weeks after the final capsaicin application. Additionally, participants will record daily pain and medication use in a mobile app. Safety will be established by there being no grade three or four adverse events according to CTCAE definitions. Grade two adverse events will be evaluated on a case by case basis throughout the duration of the study. Feasibility of monitoring neuropathic pain with the aforementioned studies will be established by participant compliance with greater than eighty percent of all study activities.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm, safety and feasibility trial assessing the suitability of an FDA approved medication for use in children with an off-label condition.|
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility of High-Dose Topical Capsaicin for the Treatment of Neuropathic Pain in Pediatric Sickle Cell Disease|
|Actual Study Start Date :||July 3, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Capsaicin Arm
Single arm to receive eight percent topical capsaicin applied to up to 4 sites of recurrent pain over one hour on an every three month schedule. Participants in this arm will receive pretreatment with topical five percent lidocaine.
Drug: Eight Percent Topical Capsaicin
See arm description
Other Name: Qutenza
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteria [ Time Frame: At the end of the 9 month study period all participant information will be reviewed and adverse events assessed. ]Safety will be established by there being no treatment-related adverse events greater than grade 2 using CTCAE definitions of adverse events. Grade 2 CTCAE events will be evaluated on a case by case basis to determine safety of continuing the study. Grade 3 events will result in immediate suspension of study activities until a full analysis of the event in question is completed.
- Compliance with Serum Substance P Levels [ Time Frame: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed. ]Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including serum substance P levels.
- Compliance with Subjective Neuropathic Pain Questionnaire [ Time Frame: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed. ]Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including completion of PainDETECT Questionnaire during study visits. The questionnaire is a validated assessment of neuropathic pain. It consists of a series of questions regarding the experience of pain for which the participant will provide an answer ranging from "never" (0 points) to "very strongly" (5 points). Points are added to provide a total score from 0 to 38. A score from 0 to 12 indicates a neuropathic pain component is unlikely, a score of 12 to 18 is equivocal, and a score greater than 18 indicates a neuropathic component is likely.
- Compliance with Quantitative Sensory Testing [ Time Frame: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed. ]Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including quantitative sensory testing using electronic von frey machine.
- Compliance with Mobile App Record Keeping [ Time Frame: Duration of study period (9 months). Mobile app recordings can be reviewed in real time and will be recorded on a weekly basis. ]Feasibility, as above, will be established by greater than 80 percent compliance with daily mobile app recordings of pain and home medication use.
- Compliance with Blood Draws for Hyperspectral Imaging Analysis for Determining Presence and Improvement of Chronic Neuropathic Pain [ Time Frame: Duration of study period (9 months). Will be drawn and processed at 6 week intervals throughout the study period. ]Feasibility will be established by the successful processing of greater than 80 percent of target number of blood samples to be sent for hyperspectral analysis, a novel test capable of detecting chronic pain states, but not yet used in the sickle cell population.
- Morphine Equivalents Utilized [ Time Frame: Duration of study period (9 months). Will be evaluated at 6 week intervals throughout the study period. ]Will assess changes in pain medication required during the course of the study period based on electronic medical record, participant report, and controlled substance monitoring database.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899246
|United States, Michigan|
|Children's Hospital of Michigan|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Alexander K Glaros, MD||Children's Hospital of Michigan|
|Principal Investigator:||Ahmar U Zaidi, MD||Children's Hospital of Michigan|
|Principal Investigator:||Callaghan Michael, MD||Children's Hospital of Michigan|