NCT01637077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2 pain

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 6, 2018

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

March 9, 2012

Results QC Date

January 8, 2018

Last Update Submit

April 4, 2018

Conditions

PainPeripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    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.

    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

    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

    From treatment initiation to 6 months.

  • The Percentage of Patients Taking Opioid Medications

    From treatment initiation to 6 months.

  • The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel

    From treatment initiation to 6 days following treatment initiation; up to 7 days

  • +4 more secondary outcomes

Study Arms (2)

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.

Drug: pregabalinOther: 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.

Drug: placeboOther: questionnaire administration

Interventions

pregabalinDRUG

Given PO

Also known as: 3-Isobutyl GABA, CI-1008, Lyrica, PD-144723
Arm I (pain therapy)
placeboDRUG

Given PO

Also known as: PLCB
Arm II (placebo)
questionnaire administrationOTHER

Ancillary studies

Arm I (pain therapy)Arm II (placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Essentia Health-Duluth CCOP

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

PainPeripheral Nervous System Diseases

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Charles L. Loprinzi, M.D.
Organization
Mayo Clinic
loprinzi.charles@mayo.edu
507/284-1623

Study Officials

  • Charles Loprinzi

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2012

First Posted

July 10, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2013

Study Completion

April 1, 2016

Last Updated

April 6, 2018

Results First Posted

April 6, 2018

Record last verified: 2018-04

Locations

US(6)