Burning Pain, Impaired Balance, Malignant Ovarian Neoplasm, Numbness, Pain, Acute, Peripheral Neuropathy, Tingling
Conditions
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).
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.
Interventions
DIAGNOSTIC_TESTDiode Laser fiber type Selective Stimulator (DLss)
A laser device to assess pain sensitivity to stimulation
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A-delta:C Pain Threshold Ratio | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between the Adelta:C Pain Threshold Ratio and Pain Development | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation | 0 |
| 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.
Diode Laser fiber type Selective Stimulator (DLss): A laser device to assess pain sensitivity to stimulation | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group A - Painful CIPN | Group B - Painless CIPN | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | — | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
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).
Time frame: Up to 24 weeks
Population: The only participant withdrew before the 21-week assessment. No outcome assessment is possible.
Secondary
Correlation Between the Adelta:C Pain Threshold Ratio and Pain Development
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.
Time frame: Up to 24 weeks
Population: The only participant withdrew before the 21-week assessment. No outcome assessment is possible.