A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
Completed · Not applicable
Conditions studied: Chemotherapy-induced Peripheral Neuropathy
In brief
The investigators propose that using the Diode Laser fiber type Selective Stimulator (DLss) in patients with chemotherapy-induced peripheral neuropathy (CIPN) will allow for the assessment of changes in small-fiber pain thresholds, to identify differences between subjects who received chemotherapy and developed painful CIPN, compared to subjects who received similar chemotherapy but did not develop painful CIPN (control group). Additionally, the investigators would like to investigate whether the response to DLss correlates with pain severity in patients with persistent painful neuropathy. The ultimate goal of this study is to develop a non-invasive, bedside quantitative test that is specific for painful CIPN. If the investigators' initial hypothesis is confirmed, the next step would be to design a prospective longitudinal study and assess changes in DLss early after initiation of chemotherapy, to determine whether this approach can help identify early predictive parameters of painful CIPN.
Key facts
- Study ID
- NCT03687970
- Run by
- Washington University School of Medicine
- People needed
- 42
- Starts
- 2018-09-17
- Expected to finish
- 2019-09-17
- Last updated by the study team
- 2021-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Group A: Painful CIPN group
- Age >18
- Distal symmetric pain distribution (both feet, with or without pain in hands).
- The pain appeared during or up to 12 weeks after treatment with oxaliplatin, cisplatin, paclitaxel, docetaxel or any combination of these.
- Score of 4 or more on Douleur Neuropathique 4 (DN4) neuropathic pain questionnaire
- Pain duration > 2 months.
- Patient report of average daily pain intensity in the last week ≥3 on 0-10 Numerical Rating Scale (NRS).
- Able and willing to sign an Institutional Review Board (IRB)-approved written informed consent.
- Group B: Control group:
- Age >18
- History of cancer diagnosis, previously treated with at least 8 infusions of chemotherapy regimen that included oxaliplatin or at least 6 infusions of chemotherapy regimen that included cisplatin, paclitaxel, docetaxel, or any combination of these.
- No ongoing pain in distal symmetric distribution (subjects with symptoms and signs such as mild numbness, or vibration sensation loss are eligible to be included in the control group).
- Able and willing to sign an IRB-approved written informed consent. * Subjects in the control group will be matched by the type of previous chemotherapy to the subjects in the Painful CIPN group. An additional attempt will be made to match controls by sex, age, cancer diagnosis, and cumulative neurotoxic chemotherapy dose.
You may not qualify if…
- History of pre-existing painful distal symmetric polyneuropathy prior to chemotherapy.
- Alternative etiology exists for the distal painful symptoms.
- Current or previous treatment with a vinca alkaloid (e.g. vincristine, vinblastine), bortezomib, or another agent which may cause major peripheral neurotoxicity.
- Pregnant
- Concomitant medication as follows:
- Patients receiving chronic daily opioids, topical lidocaine or topical capsaicin will be excluded.
- Patients receiving as needed (PRN) analgesics, including acetaminophen, NSAIDs or short-acting opioids, will be required not to take them 48h before testing, at for at least five half-lives of the specific analgesic, at the discretion of the investigators.
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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