Clinical trial · Interventional
Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN
NCT03206216CI-TRIAL-00036162terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burning Pain | — | UNRESOLVED | — |
| Impaired Balance | — | UNRESOLVED | — |
| Malignant Ovarian Neoplasm | Malignant Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Numbness | — | UNRESOLVED | — |
| Pain, Acute | — | UNRESOLVED | — |
| Peripheral Neuropathy | — | UNRESOLVED | — |
| Tingling | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diode Laser fiber type Selective Stimulator (DLss) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A - Painful CIPN
- description
- 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.
- interventionNames
- Diagnostic Test: Diode Laser fiber type Selective Stimulator (DLss)
- type
- ACTIVE_COMPARATOR
- label
- Group B - Painless CIPN
- description
- 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.
- interventionNames
- Diagnostic Test: Diode Laser fiber type Selective Stimulator (DLss)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.