PainPhase 2NCT01637077
Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel
A Phase 2 study testing pregabalin and questionnaire administration in people with Pain and Peripheral Neuropathy, run by Academic and Community Cancer Research United at 6 sites in United States.
Trial summary
This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Peripheral Neuropathy
- What is being tested?
- pregabalin and questionnaire administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2012to Apr 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
- Age > or equal to 18 years
- Ability to complete questionnaires by themselves or with assistance Paclitaxel at a dose of 80 mg/m^2 given, in the adjuvant setting, every week for a planned course of 12 weeks without any other concurrent therapy
- Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors).
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (per clinician discretion)
Who cannot join
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
- Previous diagnosis of diabetic or other peripheral neuropathy
- Current, planned or previous use, within last 6 months, of gabapentin or pregabalin
- History of allergic or other adverse reactions to gabapentin or pregabalin
Show all 11Show fewer
- Significant renal insufficiency with a history of a creatinine clearance (CrCL) < 30ml/min
- Prior exposure to neurotoxic chemotherapy
- Seizure history
- Diagnosis of fibromyalgia
- Previous exposure to paclitaxel
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Essentia Health-Duluth CCOP
Duluth, Minnesota, 55805
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Mayo Clinic
Rochester, Minnesota, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome
This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.
Read the detailed description
PRIMARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on pain related to paclitaxel-associated acute pain syndrome (P-APS). SECONDARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on paclitaxel-induced peripheral neuropathy. II. To obtain pilot data regarding the possible relative toxicities related to pregabalin therapy in this study situation. TERTIARY OBJECTIVES: I. To characterize neurological testing abnormalities that might occur with the P-APS, and to evaluate neurological testing abnormalities during the period of the longer-term chemotherapy-induced peripheral neuropathy (CIPN). II. To determine the PRO incidence and characteristics of, and change in, P-APS and paclitaxel induced more chronic CIPN over several cycles. These data will serve to confirm the results obtained in our previous natural history study N08C1. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pregabalin orally (PO) twice daily (BID), beginning on the first night of chemotherapy, for 12 weeks and then once daily (QD) for 1 week. ARM II: Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. After completion of study treatment, patients are followed up every 30 days for 6 months.
- Conditions
- Pain, Peripheral Neuropathy
- Being tested
- pregabalin, placebo, questionnaire administration
- Medical subject headings
- Pain, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
Also called 3-Isobutyl GABA, CI-1008, Lyrica, PD-144723
Given PO
placeboDrug
Also called PLCB
Given PO
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (pain therapy) | Experimental | Patients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. Receives: Drug: pregabalin; Other: questionnaire administration |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. Receives: Drug: placebo; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score
Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
Measured: From treatment initiation to 6 days following treatment initiation; up to 7 days
Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1).
Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
Measured: From treatment initiation to 6 days following treatment initiation; up to 7 days
Secondary outcomes (9)
Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment.
Average Area Under the Curve per assessment (aAUCpa) of worst, average, and least pain (items 1-3 app. IV; "Please rate any aches/pains that are NEW since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment by circling ONE number that best describes your aches/pains at its WORST in the last 24 hours.", "Please rate the same aches/pains by circling the ONE number that best describes your aches/pains at its LEAST in the last 24 hours.", "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the day-6 assessment.
Measured: From treatment initiation to 6 days following treatment initiation; up to 7 days
Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
Measured: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment
The Percentage of Patients Who Use Non-prescription Pain Medications
The percentage of patients who use non-prescription pain medications are reported by arm below.
Measured: From treatment initiation to 6 months.
The Percentage of Patients Taking Opioid Medications
The percentage of patients taking opioid medications are reported below by arm.
Measured: From treatment initiation to 6 months.
The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel
The percentage of patients who report the development of new aches/pains that they attribute to paclitaxel in the first week of chemotherapy are reported by arm below.
Measured: From treatment initiation to 6 days following treatment initiation; up to 7 days
The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V)
The worst pain reported at the end of the week for the overall week ("New aches and pains at their worst over the past week") are reported below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. The worst pain reported at the end of the week for the overall week (item 2 appendix V: "Please rate any aches/pains that you have by circling ONE number that best describes your aches/pains at its worst over the last week.") Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
Measured: From treatment initiation to 6 days following treatment initiation; up to 7 days
The Percentage of Patients Who Report, at Week's End, Using Non-prescription Pain Medications
The percentage of patients who report, at week's end, using non-prescription pain medications ("Have you used non-prescription meds like aspirin, Tylenol, Motrin, Ibuprofen, or Advil over the past week?") are reported by arm below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not.
Measured: From treatment initiation to 6 days following treatment initiation; up to 7 days
The Percentage of Patients Who Report, at Week's End, Using Opioids
The percentage of patients who report, at week's end, using opioids ("Have you used opioids like codeine, oxycodone, or morphine for this pain over the past week?") are reported by arm below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not.
Measured: From treatment initiation to 6 days following treatment initiation; up to 7 days
Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory, Autonomic, and Motor Neuropathy Subscales. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48), motor (items 37, 38, 41-45, 49), and autonomic (items 46, 47, 50) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the 6-month assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to 6-months are averaged to yield the aAUCpa per patient per subcale.
Measured: From treatment initiation to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2013
- Study completionApr 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.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic and Community Cancer Research United
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Loprinzi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637077
- Sponsor's protocol ID
- RC11C3
- Other IDs
- NCI-2011-03646
- Status last verified
- Apr 2018
- First submitted
- 9 Mar 2012
- Last updated
- 6 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome
- ClinicalTrials.gov ID
- NCT01637077
- Acronym / sponsor ID
- RC11C3
- Conditions
- Pain, Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Academic and Community Cancer Research UnitedUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 6 Apr 2018
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 pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.
Detailed description
PRIMARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on pain related to paclitaxel-associated acute pain syndrome (P-APS). SECONDARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on paclitaxel-induced peripheral neuropathy. II. To obtain pilot data regarding the possible relative toxicities related to pregabalin therapy in this study situation. TERTIARY OBJECTIVES: I. To characterize neurological testing abnormalities that might occur with the P-APS, and to evaluate neurological testing abnormalities during the period of the longer-term chemotherapy-induced peripheral neuropathy (CIPN). II. To determine the PRO incidence and characteristics of, and change in, P-APS and paclitaxel induced more chronic CIPN over several cycles. These data will serve to confirm the results obtained in our previous natural history study N08C1. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pregabalin orally (PO) twice daily (BID), beginning on the first night of chemotherapy, for 12 weeks and then once daily (QD) for 1 week. ARM II: Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. After completion of study treatment, patients are followed up every 30 days for 6 months.
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 (pain therapy) | Experimental | Drug: pregabalin, Other: questionnaire administrationPatients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
| Arm II (placebo) | Placebo comparator | Drug: placebo, Other: questionnaire administrationPatients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > or equal to 18 years
- Ability to complete questionnaires by themselves or with assistance Paclitaxel at a dose of 80 mg/m^2 given, in the adjuvant setting, every week for a planned course of 12 weeks without any other concurrent therapy
- Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors).
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (11 listed)
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
- Previous diagnosis of diabetic or other peripheral neuropathy
- Current, planned or previous use, within last 6 months, of gabapentin or pregabalin
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 |
|---|---|---|
| pregabalinAlso: 3-Isobutyl GABA, CI-1008, Lyrica, PD-144723Given PO | Drug | Arm I (pain therapy) |
| placeboAlso: PLCBGiven PO | Drug | Arm II (placebo) |
| questionnaire administrationAncillary studies | Other | Arm I (pain therapy), Arm II (placebo) |
Primary outcome
Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score
Time frame: From treatment initiation to 6 days following treatment initiation; up to 7 days
Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1).
Time frame: From treatment initiation to 6 days following treatment initiation; up to 7 days
Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).
9 secondary outcomes
Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment.
Time frame: From treatment initiation to 6 days following treatment initiation; up to 7 days
Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment
Time frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment
The Percentage of Patients Who Use Non-prescription Pain Medications
Time frame: From treatment initiation to 6 months.
The Percentage of Patients Taking Opioid Medications
Time frame: From treatment initiation to 6 months.
The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel
Time frame: From treatment initiation to 6 days following treatment initiation; up to 7 days
The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V)
Time frame: From treatment initiation to 6 days following treatment initiation; up to 7 days
The Percentage of Patients Who Report, at Week's End, Using Non-prescription Pain Medications
Time frame: From treatment initiation to 6 days following treatment initiation; up to 7 days
The Percentage of Patients Who Report, at Week's End, Using Opioids
Time frame: From treatment initiation to 6 days following treatment initiation; up to 7 days
Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales
Time frame: From treatment initiation to 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Charles Loprinzi principal investigator
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pregabalin and questionnaire administration in people with Pain and Peripheral Neuropathy, run by Academic and Community Cancer Research United at 6 sites 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 6 inclusion and 11 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 6 Apr 2018). 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?
Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score (time frame: From treatment initiation to 6 days following treatment initiation; up to 7 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 6 Apr 2018.