A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 9/30/2018 |
| Start Date: | September 17, 2018 |
| End Date: | September 17, 2019 |
| Contact: | Simon Haroutounian, Ph.D. |
| Email: | simon.haroutounian@wustl.edu |
| Phone: | 314-286-1715 |
A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN): a Feasibility Study
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.
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.
Inclusion Criteria:
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 cycles of chemotherapy
regimen that included oxaliplatin, 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Simon Haroutounian, Ph.D.
Phone: 314-286-1715
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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