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

NCT03206216 | Terminated Results DMC FDA Device

• 3 other identifiers: IRB-40358NCI-2017-01098GYN0006
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Burning Pain; Impaired Balance; Malignant Ovarian Neoplasm; Numbness; Peripheral Neuropathy; Pain, Acute; Tingling

Outcome Measures

Primary Outcomes (1)

• A-delta:C Pain Threshold Ratio

  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 Outcomes (1)

• Correlation Between the "Adelta:C Pain Threshold Ratio" and Pain Development

  Up to 24 weeks

Study Arms (2)

Group A - Painful CIPN

EXPERIMENTAL

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)

Group B - Painless CIPN

ACTIVE COMPARATOR

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)

Interventions

Diode Laser fiber type Selective Stimulator (DLss) DIAGNOSTIC_TEST

A laser device to assess pain sensitivity to stimulation

Also known as: PNS

Group A - Painful CIPN; Group B - Painless CIPN

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females equal to or greater than 18 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Pain; Ovarian Neoplasms; Hypesthesia; Peripheral Nervous System Diseases; Acute Pain; Paresthesia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Seema Nagpal, MD
• Organization: Stanford University Medical Center

snagpal@stanford.edu

650-725-8630

Study Officials

• Oliver Dorigo, MD, PhD

  Stanford University

  STUDY CHAIR

• Seema Nagpal, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: August 4, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)