PainPhase 2NCT02063698
Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome
A Phase 2 study testing auranofin and questionnaire administration in people with Pain, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- auranofin and questionnaire administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2014to 11 Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized, Placebo-Controlled Study to Test Auranofin (Ridaura®) to Control the Paclitaxel-Induced Pain Syndrome (PIAPS)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Pain
- Being tested
- auranofin, placebo, questionnaire administration
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auranofinDrug
Also called Ridaura
Given PO
placeboOther
Also called PLCB
Given PO
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (auranofin) | Experimental | Patients receive auranofin PO on day 2. Receives: Drug: auranofin; Other: questionnaire administration |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO on day 2. Receives: Other: placebo; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 8 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study start19 Feb 2014
- Primary completion11 Nov 2015
- Study completion11 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063698
- Sponsor's protocol ID
- MC1364
- Other IDs
- NCI-2014-00165, MC1364, P30CA015083
- Status last verified
- Dec 2018
- First submitted
- 12 Feb 2014
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Placebo-Controlled Study to Test Auranofin (Ridaura®) to Control the Paclitaxel-Induced Pain Syndrome (PIAPS)
- ClinicalTrials.gov ID
- NCT02063698
- Acronym / sponsor ID
- MC1364
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Feb 2014 (actual)
- Primary completion
- 11 Nov 2015 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 23 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (auranofin) | Experimental | Drug: auranofin, Other: questionnaire administrationPatients receive auranofin PO on day 2. |
| Arm II (placebo) | Placebo comparator | Other: placebo, Other: questionnaire administrationPatients receive placebo PO on day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auranofinAlso: RidauraGiven PO | Drug | Arm I (auranofin) |
| placeboAlso: PLCBGiven PO | Other | Arm II (placebo) |
| questionnaire administrationAncillary studies | Other | Arm I (auranofin), Arm II (placebo) |
Primary outcome
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)
Time frame: 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
Time frame: 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.
7 secondary outcomes
Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8
Time frame: Up to 28 days
Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4
Time frame: Up to 28 days
Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5
Time frame: Up to 5 days
Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8
Time frame: Up to 8 days
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain
Time frame: Up to 5 days
Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.
Time frame: Up to 5 days
Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.
Time frame: Up to 6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminah Jatoi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing auranofin and questionnaire administration in people with Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.