Pain
Conditions
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.
Interventions
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to 28 days | The primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms. |
| Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8 | Up to 8 days | Area under the curve (AUC) Summary of Worst Pain in the last 24 hours from days 2 to 8. On a scale of 0-100, with 100=Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 | Up to 5 days | Cramp Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 5 were analyzed (those who checked 'cramping' are summarized by the 'Yes' row below and those who did not check 'cramping' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used. |
| Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 | Up to 8 days | Gnawing Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 8 were analyzed (those who checked 'gnawing' are summarized by the 'Yes' row below and those who did not check 'gnawing' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used. |
| Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8 | Up to 28 days | Normalized AUC for BPI Average pain from the modified BPI in the last 24 hours from days 2 to 8. On a scale of 0-100 with 100:Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain on the average.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms. |
| Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. | Up to 5 days | Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Lower arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used. |
| Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. | Up to 6 days | Location of New Pain Patient had in the last 24 hours on day 6 PIAPS Lower arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used. |
| Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain | Up to 5 days | Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Upper arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, above the elbow' are summarized by the 'Yes' row below and those who did not check 'arm, above the elbow' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used. |
| Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | Up to 28 days | The maximum grade for each type of toxicity will be recorded for each patient. The count of participants with worst adverse events considered at least possibly related to treatment by maximum grade are reported below. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Auranofin) Patients receive auranofin PO on day 2. | 15 |
| Arm II (Placebo) Patients receive placebo PO on day 2. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not complete booklet for days 2-8 | 1 | 2 |
Baseline characteristics
| Characteristic | Arm I (Auranofin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 9 | 57.4 years STANDARD_DEVIATION 9.7 | 60.1 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 15 / 15 | 15 / 15 |
| serious Total, serious adverse events | 2 / 15 | 5 / 15 |
Outcome results
Primary
Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8
Area under the curve (AUC) Summary of Worst Pain in the last 24 hours from days 2 to 8. On a scale of 0-100, with 100=Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.
Time frame: Up to 8 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Auranofin) | Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8 | 55.1 score on a scale * day | Standard Deviation 19 |
| Arm II (Placebo) | Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8 | 61.3 score on a scale * day | Standard Deviation 21.8 |
p-value: 0.44Equal variance t-test
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)
The primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms.
Time frame: Up to 28 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm I (Auranofin) | 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) | Day 2: BPI Worst Pain Past 24 Hours | <4 | 10 Participants |
| Arm I (Auranofin) | 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) | Day 2: BPI Worst Pain Past 24 Hours | >=4 | 4 Participants |
| Arm I (Auranofin) | 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) | Day 3: BPI Worst Pain Past 24 Hours | <4 | 5 Participants |
| Arm I (Auranofin) | 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) | Day 3: BPI Worst Pain Past 24 Hours | >=4 | 9 Participants |
| Arm I (Auranofin) | 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) | Day 4: BPI Worst Pain Past 24 Hours | <4 | 2 Participants |
| Arm I (Auranofin) | 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) | Day 4: BPI Worst Pain Past 24 Hours | >=4 | 12 Participants |
| Arm I (Auranofin) | 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) | Day 5: BPI Worst Pain Past 24 Hours | <4 | 3 Participants |
| Arm I (Auranofin) | 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) | Day 5: BPI Worst Pain Past 24 Hours | >=4 | 11 Participants |
| Arm I (Auranofin) | 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) | Day 6: BPI Worst Pain Past 24 Hours | <4 | 7 Participants |
| Arm I (Auranofin) | 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) | Day 6: BPI Worst Pain Past 24 Hours | >=4 | 7 Participants |
| Arm I (Auranofin) | 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) | Day 7: BPI Worst Pain Past 24 Hours | <4 | 8 Participants |
| Arm I (Auranofin) | 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) | Day 7: BPI Worst Pain Past 24 Hours | >=4 | 6 Participants |
| Arm I (Auranofin) | 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) | Day 8: BPI Worst Pain Past 24 Hours | <4 | 10 Participants |
| Arm I (Auranofin) | 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) | Day 8: BPI Worst Pain Past 24 Hours | >=4 | 4 Participants |
| Arm II (Placebo) | 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) | Day 7: BPI Worst Pain Past 24 Hours | <4 | 8 Participants |
| Arm II (Placebo) | 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) | Day 2: BPI Worst Pain Past 24 Hours | <4 | 10 Participants |
| Arm II (Placebo) | 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) | Day 5: BPI Worst Pain Past 24 Hours | >=4 | 6 Participants |
| Arm II (Placebo) | 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) | Day 2: BPI Worst Pain Past 24 Hours | >=4 | 3 Participants |
| Arm II (Placebo) | 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) | Day 8: BPI Worst Pain Past 24 Hours | <4 | 7 Participants |
| Arm II (Placebo) | 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) | Day 3: BPI Worst Pain Past 24 Hours | <4 | 7 Participants |
| Arm II (Placebo) | 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) | Day 6: BPI Worst Pain Past 24 Hours | <4 | 8 Participants |
| Arm II (Placebo) | 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) | Day 3: BPI Worst Pain Past 24 Hours | >=4 | 6 Participants |
| Arm II (Placebo) | 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) | Day 7: BPI Worst Pain Past 24 Hours | >=4 | 5 Participants |
| Arm II (Placebo) | 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) | Day 4: BPI Worst Pain Past 24 Hours | <4 | 4 Participants |
| Arm II (Placebo) | 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) | Day 6: BPI Worst Pain Past 24 Hours | >=4 | 5 Participants |
| Arm II (Placebo) | 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) | Day 4: BPI Worst Pain Past 24 Hours | >=4 | 9 Participants |
| Arm II (Placebo) | 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) | Day 8: BPI Worst Pain Past 24 Hours | >=4 | 6 Participants |
| Arm II (Placebo) | 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) | Day 5: BPI Worst Pain Past 24 Hours | <4 | 7 Participants |
Comparison: Day 2: BPI Worst Pain Past 24 Hoursp-value: 1Fisher Exact
Comparison: Day 3: BPI Worst Pain Past 24 Hoursp-value: 0.45Fisher Exact
Comparison: Day 4: BPI Worst Pain Past 24 Hoursp-value: 0.38Fisher Exact
Comparison: Day 5: BPI Worst Pain Past 24 Hoursp-value: 0.12Fisher Exact
Comparison: Day 6: BPI Worst Pain Past 24 Hoursp-value: 0.7Fisher Exact
Comparison: Day 7: BPI Worst Pain Past 24 Hoursp-value: 1Fisher Exact
Comparison: Day 8: BPI Worst Pain Past 24 Hoursp-value: 0.44Fisher Exact
Secondary
Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5
Cramp Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 5 were analyzed (those who checked 'cramping' are summarized by the 'Yes' row below and those who did not check 'cramping' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time frame: Up to 5 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Auranofin) | Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 | Missing | 1 Participants |
| Arm I (Auranofin) | Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 | No | 14 Participants |
| Arm I (Auranofin) | Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 | Yes | 0 Participants |
| Arm II (Placebo) | Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 | Missing | 2 Participants |
| Arm II (Placebo) | Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 | No | 9 Participants |
| Arm II (Placebo) | Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5 | Yes | 4 Participants |
p-value: 0.025Chi-squared
Secondary
Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8
Gnawing Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 8 were analyzed (those who checked 'gnawing' are summarized by the 'Yes' row below and those who did not check 'gnawing' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time frame: Up to 8 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Auranofin) | Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 | Missing | 1 Participants |
| Arm I (Auranofin) | Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 | No | 14 Participants |
| Arm I (Auranofin) | Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 | Yes | 0 Participants |
| Arm II (Placebo) | Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 | Missing | 2 Participants |
| Arm II (Placebo) | Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 | No | 8 Participants |
| Arm II (Placebo) | Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8 | Yes | 5 Participants |
p-value: 0.01Chi-squared
Secondary
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.
Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Lower arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time frame: Up to 5 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. | Missing | 1 Participants |
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. | No | 8 Participants |
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. | Yes | 6 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. | Missing | 2 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. | No | 13 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain. | Yes | 0 Participants |
p-value: 0.01Chi-squared
Secondary
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain
Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Upper arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, above the elbow' are summarized by the 'Yes' row below and those who did not check 'arm, above the elbow' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time frame: Up to 5 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain | Yes | 5 Participants |
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain | Missing | 1 Participants |
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain | No | 9 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain | Yes | 0 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain | Missing | 2 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain | No | 13 Participants |
p-value: 0.02Chi-squared
Secondary
Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.
Location of New Pain Patient had in the last 24 hours on day 6 PIAPS Lower arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.
Time frame: Up to 6 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. | Missing | 1 Participants |
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. | No | 10 Participants |
| Arm I (Auranofin) | Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. | Yes | 4 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. | Missing | 2 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. | No | 13 Participants |
| Arm II (Placebo) | Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain. | Yes | 0 Participants |
p-value: 0.04Chi-squared
Secondary
Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8
Normalized AUC for BPI Average pain from the modified BPI in the last 24 hours from days 2 to 8. On a scale of 0-100 with 100:Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain on the average.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.
Time frame: Up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Auranofin) | Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8 | 67.0 score on a scale | Standard Deviation 17.9 |
| Arm II (Placebo) | Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8 | 78.1 score on a scale | Standard Deviation 18.2 |
p-value: 0.13Equal variance t-test
Secondary
Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4
The maximum grade for each type of toxicity will be recorded for each patient. The count of participants with worst adverse events considered at least possibly related to treatment by maximum grade are reported below.
Time frame: Up to 28 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Auranofin) | Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | 1-Mild | 9 Participants |
| Arm I (Auranofin) | Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | 2-Moderate | 4 Participants |
| Arm I (Auranofin) | Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | 3-Severe | 2 Participants |
| Arm I (Auranofin) | Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | 4-Life-Threatening | 0 Participants |
| Arm II (Placebo) | Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | 4-Life-Threatening | 1 Participants |
| Arm II (Placebo) | Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | 1-Mild | 7 Participants |
| Arm II (Placebo) | Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | 3-Severe | 6 Participants |
| Arm II (Placebo) | Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4 | 2-Moderate | 1 Participants |