Phase 2
Completed N=30
Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome
Source: ClinicalTrials.gov NCT02063698 ↗Enrolled (actual)
30
Serious AEs
23.3%
Results posted
Apr 2019
Primary outcomePrimary: Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI) — 10; 10; 4; 3 Participants — p=1.0
Summary
This randomized pilot clinical trial studies whether auranofin will relieve pain following paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being studied to see if it will decrease pain following paclitaxel.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI) |
10; 10; 4; 3; 5; 7 | 1.0 |
| PRIMARY Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8 |
55.1; 61.3 | 0.44 |
| SECONDARY Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8 |
67.0; 78.1 | 0.13 |
| SECONDARY Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 |
9; 7; 4; 1; 2; 6 | — |
| SECONDARY Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 |
1; 2; 14; 9; 0; 4 | 0.025 sig |
| SECONDARY Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 |
1; 2; 14; 8; 0; 5 | 0.01 sig |
| SECONDARY Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain |
1; 2; 9; 13; 5; 0 | 0.02 sig |
| SECONDARY Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. |
1; 2; 8; 13; 6; 0 | 0.01 sig |
| SECONDARY Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. |
1; 2; 10; 13; 4; 0 | 0.04 sig |
Eligibility Criteria
Inclusion Criteria
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Platelet count (PLT) >= 100,000/mm^3
- Creatinine = = 9 mg/dL
- Negative urine or serum pregnancy test performed = = 70 mg/m^2 =< 14 days from randomization
- Ability to complete the questionnaires or to do so with assistance
Exclusion Criteria
- Pregnant women
- Nursing women
- Any woman of childbearing potential or male partner of a woman of childbearing potential unwilling to employ acceptable contraception throughout the study and for at least 30 days after the last dose of the study drug
- History of gold-induced disorders, including but not limited to, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasias or other severe hematologic disorders; history of severe allergic or anaphylactic reactions or hypersensitivity to auranofin or other gold compounds
- Currently receiving Dilantin (phenytoin) or auranofin or another gold-containing compound
- Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofin
- Currently receiving immune-modulating therapies
Data sourced from ClinicalTrials.gov (NCT02063698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.