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Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN

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ClinicalTrials.gov Identifier: NCT03206216
Recruitment Status : Terminated (Business decision)
First Posted : July 2, 2017
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Oliver Dorigo, Stanford University

Brief Summary:
This clinical trial studies how well Diode laser fiber type Selective Stimulator (DLss) works in predicting pain development in patients with ovarian cancer who are receiving chemotherapy. Stimulating of the pain nerve fibers in the skin with laser light stimulation may help to predict whether a patient will develop painful peripheral neuropathy, correlate with the severity of neuropathy during and after chemotherapy treatment, and may help to explain the mechanisms of chemotherapy-induced neuropathic pain (CIPN).

Condition or disease Intervention/treatment Phase
Burning Pain Impaired Balance Malignant Ovarian Neoplasm Numbness Peripheral Neuropathy Pain, Acute Tingling Diagnostic Test: Diode Laser fiber type Selective Stimulator (DLss) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN
Actual Study Start Date : August 4, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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.
Diagnostic Test: Diode Laser fiber type Selective Stimulator (DLss)
A laser device to assess pain sensitivity to stimulation
Other Name: PNS

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.
Diagnostic Test: Diode Laser fiber type Selective Stimulator (DLss)
A laser device to assess pain sensitivity to stimulation
Other Name: PNS




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females equal to or greater than 18 years of age
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03206216


Locations
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United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Study Chair: Oliver Dorigo, MD, PhD Stanford University
Principal Investigator: Seema Nagpal, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Oliver Dorigo, Stanford University:
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Responsible Party: Oliver Dorigo, Associate Professor of Obstetrics and Gynecology, Stanford University
ClinicalTrials.gov Identifier: NCT03206216    
Other Study ID Numbers: IRB-40358
NCI-2017-01098 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GYN0006 ( Other Identifier: OnCore )
First Posted: July 2, 2017    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Peripheral Nervous System Diseases
Acute Pain
Neuromuscular Diseases
Nervous System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pain
Neurologic Manifestations