Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
600 participants
INTERVENTIONAL
2012-11-01
2015-03-18
Brief Summary
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Detailed Description
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Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prophylactic naproxen
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Naproxen
Pegfilgrastim
Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.
Chemotherapy
The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
Prophylactic loratadine
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Loratadine
Pegfilgrastim
Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.
Chemotherapy
The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
No prophylactic treatment
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
Pegfilgrastim
Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.
Chemotherapy
The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
Interventions
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Naproxen
Loratadine
Pegfilgrastim
Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.
Chemotherapy
The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy
* Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the treatment period
* Subject has provided informed consent
Exclusion Criteria
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
* Adequately treated cervical carcinoma in situ without evidence of disease
* Planning to receive weekly chemotherapy
* Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator
* Chronic oral steroid use. Premedication related to the administration of chemotherapy, and use of anti-emetics is allowed, per usual clinical practice
* Chronic use of oral non-steroidal anti-inflammatory drug (NSAIDs) or oral antihistamines outside of those dictated by the randomization groups outlined in the protocol, with the following exception:
\- Chronic oral aspirin use for cardiovascular-related indications
* Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis
* Prior use of granulocyte colony stimulating factor (G-CSF)
* History of clinically significant gastrointestinal (GI) bleeding, history of GI ulcers or active GI bleeding within 6 months prior to randomization
* History of clinically significant bleeding disorders, thromboembolism within 6 months prior to randomization
* Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony-stimulating factor (GM-CSF) (sargramostim) use
* Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)
* Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer
* Currently enrolled in, or less than 30 days since ending, any pain intervention study
* Female subjects who are pregnant or lactating or of reproductive potential not willing to employ an effective method of birth control during treatment and for 17 days after discontinuing study treatment
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
18 Years
100 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Muscle Shoals, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Fullerton, California, United States
Research Site
Santa Maria, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Torrance, California, United States
Research Site
Whittier, California, United States
Research Site
Denver, Colorado, United States
Research Site
Golden, Colorado, United States
Research Site
Littleton, Colorado, United States
Research Site
Norwich, Connecticut, United States
Research Site
Stamford, Connecticut, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Daytona Beach, Florida, United States
Research Site
Daytona Beach, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Lakeland, Florida, United States
Research Site
New Port Richey, Florida, United States
Research Site
Plantation, Florida, United States
Research Site
Stuart, Florida, United States
Research Site
Augusta, Georgia, United States
Research Site
Thomasville, Georgia, United States
Research Site
Elmhurst, Illinois, United States
Research Site
Gurnee, Illinois, United States
Research Site
Mount Vernon, Illinois, United States
Research Site
Skokie, Illinois, United States
Research Site
Urbana, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
South Bend, Indiana, United States
Research Site
Sioux City, Iowa, United States
Research Site
Waterloo, Iowa, United States
Research Site
Hutchinson, Kansas, United States
Research Site
Lexington, Kentucky, United States
Research Site
Louisville, Kentucky, United States
Research Site
Mount Sterling, Kentucky, United States
Research Site
Paducah, Kentucky, United States
Research Site
Alexandria, Louisiana, United States
Research Site
Lafayette, Louisiana, United States
Research Site
Marrero, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Cumberland, Maryland, United States
Research Site
Randallstown, Maryland, United States
Research Site
Rockville, Maryland, United States
Research Site
Westminster, Maryland, United States
Research Site
Lowell, Massachusetts, United States
Research Site
Battle Creek, Michigan, United States
Research Site
Duluth, Minnesota, United States
Research Site
Saint Cloud, Minnesota, United States
Research Site
Jackson, Mississippi, United States
Research Site
Jefferson City, Missouri, United States
Research Site
Kansas City, Missouri, United States
Research Site
Saint Joseph, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Billings, Montana, United States
Research Site
Omaha, Nebraska, United States
Research Site
Nashua, New Hampshire, United States
Research Site
Denville, New Jersey, United States
Research Site
East Syracuse, New York, United States
Research Site
Johnson City, New York, United States
Research Site
Gastonia, North Carolina, United States
Research Site
Hickory, North Carolina, United States
Research Site
Pinehurst, North Carolina, United States
Research Site
Massillon, Ohio, United States
Research Site
Zanesville, Ohio, United States
Research Site
Bend, Oregon, United States
Research Site
Bethlehem, Pennsylvania, United States
Research Site
Langhorne, Pennsylvania, United States
Research Site
Florence, South Carolina, United States
Research Site
Watertown, South Dakota, United States
Research Site
Bristol, Tennessee, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Plano, Texas, United States
Research Site
Ogden, Utah, United States
Research Site
Chesapeake, Virginia, United States
Research Site
Spokane, Washington, United States
Research Site
Huntington, West Virginia, United States
Research Site
Janesville, Wisconsin, United States
Research Site
Madison, Wisconsin, United States
Research Site
Racine, Wisconsin, United States
Research Site
Wauwatosa, Wisconsin, United States
Research Site
Weston, Wisconsin, United States
Countries
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References
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Kirshner JJ, McDonald MC 3rd, Kruter F, Guinigundo AS, Vanni L, Maxwell CL, Reiner M, Upchurch TE, Garcia J, Morrow PK. NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim. Support Care Cancer. 2018 Apr;26(4):1323-1334. doi: 10.1007/s00520-017-3959-2. Epub 2017 Nov 16.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20110147
Identifier Type: -
Identifier Source: org_study_id
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