Clinical trial NCT01637077: Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel
Official title: RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Peripheral Neuropathy
Lead sponsor: Academic and Community Cancer Research United
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: From treatment initiation to 6 days following treatment initiation; up to 7 days
measure: Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1).
timeFrame: From treatment initiation to 6 days following treatment initiation; up to 7 days
Secondary outcomes:
measure: Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment.
timeFrame: From treatment initiation to 6 days following treatment initiation; up to 7 days
measure: Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment
timeFrame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment
measure: The Percentage of Patients Who Use Non-prescription Pain Medications
timeFrame: From treatment initiation to 6 months.
measure: The Percentage of Patients Taking Opioid Medications
timeFrame: From treatment initiation to 6 months.
measure: The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel
timeFrame: From treatment initiation to 6 days following treatment initiation; up to 7 days
measure: The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V)
timeFrame: From treatment initiation to 6 days following treatment initiation; up to 7 days
measure: The Percentage of Patients Who Report, at Week's End, Using Non-prescription Pain Medications
timeFrame: From treatment initiation to 6 days following treatment initiation; up to 7 days
measure: The Percentage of Patients Who Report, at Week's End, Using Opioids
timeFrame: From treatment initiation to 6 days following treatment initiation; up to 7 days
measure: Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales
timeFrame: From treatment initiation to 6 months.
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Duluth
country: United States
facility: Essentia Health-Duluth CCOP
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: Coborn Cancer Center at Saint Cloud Hospital
state: Minnesota
city: Omaha
country: United States
facility: Missouri Valley Cancer Consortium
state: Nebraska
city: Marshfield
country: United States
facility: Marshfield Clinic - Marshfield Center
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Charles Loprinzi
role: PRINCIPAL_INVESTIGATOR
References: