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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00165 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC1364 | Other Identifier | Mayo Clinic | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (auranofin) | Experimental | Patients receive auranofin PO on day 2. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO on day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| auranofin | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days |
| 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. | Up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Auranofin) | Patients receive auranofin PO on day 2. |
| FG001 | Arm II (Placebo) | Patients receive placebo PO on day 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Auranofin) | Patients receive auranofin PO on day 2. |
| BG001 | Arm II (Placebo) | Patients receive placebo PO on day 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 28 days |
|
Up to 28 days
Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Auranofin) | Patients receive auranofin PO on day 2. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aminah Jatoi, MD | Mayo Clinic | (507) 284-7202 | Jatoi.Aminah@mayo.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001310 | Auranofin |
| ID | Term |
|---|---|
| D006051 | Aurothioglucose |
| D050607 | Organogold Compounds |
| D009942 | Organometallic Compounds |
| D009930 | Organic Chemicals |
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| placebo |
| Other |
Given PO |
|
|
| questionnaire administration | Other | Ancillary studies |
|
| Up to 28 days |
| 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. | Up to 28 days |
| 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. | Up to 5 days |
| 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. | Up to 8 days |
| 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. | Up to 5 days |
| 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. | Up to 5 days |
| 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. | Up to 6 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Arm I (Auranofin) |
Patients receive auranofin PO on day 2. |
| OG001 | Arm II (Placebo) | Patients receive placebo PO on day 2. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale * day | Up to 8 days |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 28 days |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 5 days |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 8 days |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 5 days |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 5 days |
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|
|
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| 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. | Posted | Count of Participants | Participants | Up to 6 days |
|
|
|
|
| 15 |
| 2 |
| 15 |
| 15 |
| 15 |
| EG001 | Arm II (Placebo) | Patients receive placebo PO on day 2. | 0 | 15 | 5 | 15 | 15 | 15 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Renal calculi | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
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| White blood cell decreased | Investigations | MedDRA 12 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
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| 3-Severe |
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| 4-Life-Threatening |
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| Yes |
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| Yes |
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| Yes |
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| Yes |
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| Yes |
|