- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03206216
Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Laser stimulation, similar to what is being used in the DLss, has been used in pain clinics and research since 1975 as a diagnostic test for pain sensitivity. It is widely considered to be both useful and safe. Laser irradiation /stimulation simultaneously can activate either the heat-sensitive A-delta or C never fibers, with the difference in affected nerves being primarily on the basis of different pulse duration and different diameter of the simulation target. The laser for both type of simulation is set to 980 nanometers.
Laser irradiation intensity is measured as the milli-amperes (mA) required to generate that laser intensity. The pain sensitively of A-delta and C fibers are assessed by specific protocols (A-delta protocol: 60 millisecond duration, 980 nm stimuli, 1 mm diameter simulation target. C protocol: 2 second duration, 5 mm diameter simulation target).
Pain sensitivity is assessed as the ratio of painful laser intensity between the A-delta and C fibers (A-delta:C pain ratio).
Participants with ovarian cancer, with either painful (Group A) or painless (Group B) chemotherapy-induced peripheral neuropathy (CIPN), were to be assessed for pain sensitivity after 9 and 21 weeks of chemotherapy with Diode Laser fiber type Selective Stimulator (DLss). Both painful or painless CIPN are undesirable chemotherapy-induced side effects. The same testing protocol was used for these groups (ie, any difference between the groups would be attributed to differences in pain sensitivity between the groups). Patients would report the stimulation on a 0 to 100 scale, with 0 = no sensation; 10 = definite sensation; 0 to 40 = "painful"; and 100 = worst imaginable pain.
PRIMARY OBJECTIVES:
- Determine if there is a difference in the A-delta:C pain threshold ratio for patients with painful chemotherapy-induced peripheral neuropathy (CIPN) compared to patients with painless CIPN.
- Determine the A-delta:C ratio over time in patients with CIPN.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Palo Alto, California, United States, 94304
- Stanford University, School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
- Pathologically-proven ovarian cancer, or cancer of mullerian origin, that was or will be treated with a 1st-line taxane plus a platinum-based chemotherapy regimen.
- GROUP A (painful neuropathy group): Subjective symptoms of painful peripheral neuropathy (burning, stabbing, throbbing, painful tingling, aching in the fingers and/or toes) that is greater than or equal to 10 on a scale of 0 to 100 in the neuropathic pain questionnaire
- GROUP B (painless neuropathy group): Subjective symptoms of painless neuropathy (loss of sensation, worsening balance, strange sensation in fingers and/or toes) or no complaints related to neuropathy.
- Life expectancy of 6 months
- Ability to understand the study protocol, participate in testing, and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA
- Received prior chemotherapy for ovarian cancer or cancer of mullerian origin other than 1st-line treatment with a taxane + platinum based regimen.
- No concurrent investigational drugs.
- Received investigational drugs suspected to cause peripheral neuropathy.
- History of B12 deficiency
- History of neuropathy or numbness/tingling suspicious for neuropathy, prior to the first dose of chemotherapy for ovarian cancer
- Prior treatment for other cancers that included drugs known to cause neuropathy (including but are not limited to vinca-alkaloids, platinums, taxanes, bortizomib).
- Known peripheral vascular disease
- Chronic daily headache or headache for more than 14 days of the month
- Pain rated 50 or higher on a scale of 0 to 100, with 0 = no pain at all and 100 = worst pain imaginable.
- Pregnant or nursing
- HIV-positive
- Do not speak or read English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A - Painful CIPN
Participants with painful chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy.
A questionnaire is used to assess the level of pain after stimulation.
|
A laser device to assess pain sensitivity to stimulation
Other Names:
|
Active Comparator: Group B - Painless CIPN
Participants with painless chemotherapy-induced peripheral neuropathy (CIPN) undergo Diode Laser fiber type Selective Stimulator (DLss) test over 30 minutes at 9 and 21 weeks after the first day of standard of care chemotherapy.
A questionnaire is used to assess the level of pain after stimulation.
|
A laser device to assess pain sensitivity to stimulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A-delta:C Pain Threshold Ratio
Time Frame: Up to 24 weeks
|
The "A-delta:C pain threshold ratio" is calculated based on the A-delta-fiber and C-fiber pain thresholds.
The outcome was the difference in the A-delta:C pain ratio between the 9-week assessment and the 21-week assessment, to be reported as the mean with standard deviation for participant with painful CIPN (Group A) or painless CIPN (Group B).
|
Up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation Between the "Adelta:C Pain Threshold Ratio" and Pain Development
Time Frame: Up to 24 weeks
|
A Spearman correlation coefficient will be obtained for the A-delta:C pain threshold ratio as measured at 9 weeks (dependent variable) assessed against the presence or absence of pain (binary pain value) at 21 weeks (independent variable).
The Spearman correlation coefficient will be obtained by logistic regression analysis.
|
Up to 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Oliver Dorigo, MD, PhD, Stanford University
- Principal Investigator: Seema Nagpal, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neurologic Manifestations
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Ovarian Neoplasms
- Pain
- Acute Pain
Other Study ID Numbers
- IRB-40358
- NCI-2017-01098 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- GYN0006 (Other Identifier: OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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