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Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

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ClinicalTrials.gov Identifier: NCT01637077
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Academic and Community Cancer Research United

March 9, 2012
July 10, 2012
January 8, 2018
April 6, 2018
April 6, 2018
January 2012
November 2013   (Final data collection date for 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 ]
    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).
Number of patients pregabalin has any effect on the prevention of paclitaxel-associated acute pain syndrome (P-APS) at 180 days. [ Time Frame: From treatment initiation to 6 months. ]
Descriptive statistics and statistical plots will be mainly utilized. Means and 95% confidence intervals (CIs) will be estimated.
Complete list of historical versions of study NCT01637077 on ClinicalTrials.gov Archive Site
  • 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 ]
    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.
  • 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 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.
  • The Percentage of Patients Who Use Non-prescription Pain Medications [ Time Frame: From treatment initiation to 6 months. ]
    The percentage of patients who use non-prescription pain medications are reported by arm below.
  • The Percentage of Patients Taking Opioid Medications [ Time Frame: From treatment initiation to 6 months. ]
    The percentage of patients taking opioid medications are reported below by arm.
  • 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 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.
  • 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 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).
  • 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 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.
  • 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 ]
    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.
  • Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales [ Time Frame: From treatment initiation to 6 months. ]
    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.
  • Number of patients benefit of pregabalin on paclitaxel-induced peripheral neuropathy at 6 months. [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ]
  • Number of toxicities related to pregabalin therapy in this study situation at 6 months. [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ]
Not Provided
Not Provided
 
Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
  • Pain
  • Peripheral Neuropathy
  • Drug: pregabalin
    Given PO
    Other Names:
    • 3-Isobutyl GABA
    • CI-1008
    • Lyrica
    • PD-144723
  • Drug: placebo
    Given PO
    Other Name: PLCB
  • Other: questionnaire administration
    Ancillary studies
  • Experimental: Arm I (pain therapy)
    Patients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
    Interventions:
    • Drug: pregabalin
    • Other: questionnaire administration
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
    Interventions:
    • Drug: placebo
    • Other: questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
Same as current
April 2016
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01637077
RC11C3
NCI-2011-03646 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Yes
Not Provided
Plan to Share IPD: Undecided
Academic and Community Cancer Research United
Academic and Community Cancer Research United
Not Provided
Principal Investigator: Charles Loprinzi Mayo Clinic
Academic and Community Cancer Research United
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP