Clinical trial NCT02063698: Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome
Official title: A Pilot Randomized, Placebo-Controlled Study to Test Auranofin (Ridaura®) to Control the Paclitaxel-Induced Pain Syndrome (PIAPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Up to 28 days
measure: Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8
timeFrame: Up to 8 days
Secondary outcomes:
measure: Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8
timeFrame: Up to 28 days
measure: Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4
timeFrame: Up to 28 days
measure: Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5
timeFrame: Up to 5 days
measure: Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8
timeFrame: Up to 8 days
measure: Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain
timeFrame: Up to 5 days
measure: Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.
timeFrame: Up to 5 days
measure: Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.
timeFrame: Up to 6 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi
role: PRINCIPAL_INVESTIGATOR
References: