Overview

This trial is active, not recruiting.

Condition pain
Treatments auranofin, placebo, questionnaire administration
Target JAK
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date February 2014
End date March 2017
Trial size 30 participants
Trial identifier NCT02063698, MC1364, NCI-2014-00165, P30CA015083

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
Patients receive auranofin PO on day 2.
auranofin Ridaura
Given PO
questionnaire administration
Ancillary studies
(Placebo Comparator)
Patients receive placebo PO on day 2.
placebo PLCB
Given PO
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
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)
time frame: Up to 28 days
Proportion of patients who rate their pain as >= 4 assessed by the BPI
time frame: Up to 28 days

Secondary Outcomes

Measure
Area under the curve for other pain items on the modified BPI
time frame: Up to 28 days
Locations of pain
time frame: Up to 28 days
Average responses to questions from the modified BPI
time frame: Up to 28 days
Incidence of adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4
time frame: Up to 28 days
Pain descriptions and locations as measured by the PIAPS Symptom Summary
time frame: Up to 28 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Absolute neutrophil count (ANC) >= 1500/mm^3 - Platelet count (PLT) >= 100,000/mm^3 - Creatinine =< 2 x upper limit of normal (ULN) - Either serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN - Total/direct bilirubin =< 1.5 x ULN - Alkaline phosphatase =< 1.5 x ULN - Hemoglobin >= 9 mg/dL - Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only - Previously experienced paclitaxel induced pain during a current or past paclitaxel treatment that the treating healthcare provider thinks is consistent with the paclitaxel-induced acute pain syndrome; note: formal documentation of prior pain is not required - Scheduled to receive paclitaxel at a dose >= 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

Additional Information

Official title A Pilot Randomized, Placebo-Controlled Study to Test Auranofin (Ridaura®) to Control the Paclitaxel-Induced Pain Syndrome (PIAPS)
Principal investigator Aminah Jatoi
Description PRIMARY OBJECTIVES: I. Determine whether one dose of auranofin given the day following administration of paclitaxel decreases pain as assessed by daily completion of the Modified Brief Pain Inventory scale for seven days. SECONDARY OBJECTIVES: I. Assess whether auranofin is well tolerated in this setting. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive auranofin orally (PO) on day 2. ARM II: Patients receive placebo PO on day 2. After completion of study treatment, patients are followed up at 21-28 days.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.
Location data was received from the National Cancer Institute and was last updated in June 2016.