NOLAN: Naproxen or Loratadine and Neulasta
NOLAN
Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim
1 other identifier
interventional
600
1 country
83
Brief Summary
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2012
83 active sites
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
First Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2015
CompletedResults Posted
Study results publicly available
March 9, 2016
CompletedJanuary 30, 2018
January 1, 2018
2.4 years
October 19, 2012
February 9, 2016
January 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Bone Pain (All Grades) in Cycle 1
Bone pain data were captured as part of standard adverse event (AE) reporting.
Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)
Secondary Outcomes (6)
Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles
Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)
Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles
Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)
Mean Patient-reported Bone Pain by Cycle and Across Cycles
Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Maximum Patient-reported Bone Pain by Cycle and Across Cycles
Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Area Under the Curve (AUC) for Patient-reported Bone Pain
Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
- +1 more secondary outcomes
Study Arms (3)
Prophylactic naproxen
EXPERIMENTALParticipants 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.
Prophylactic loratadine
EXPERIMENTALParticipants 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.
No prophylactic treatment
OTHERParticipants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
Interventions
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.
The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
Eligibility Criteria
You may not qualify if:
- History of other malignancy within the past 5 years, with the following exceptions:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (83)
Research Site
Muscle Shoals, Alabama, 35661, United States
Research Site
Anaheim, California, 92801, United States
Research Site
Fullerton, California, 92835, United States
Research Site
Santa Maria, California, 93454, United States
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Santa Rosa, California, 95403, United States
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Torrance, California, 90501, United States
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Whittier, California, 90603, United States
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Denver, Colorado, 80210, United States
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Golden, Colorado, 80401, United States
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Littleton, Colorado, 80122, United States
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Norwich, Connecticut, 06360, United States
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Stamford, Connecticut, 06902, United States
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Boynton Beach, Florida, 33426, United States
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Daytona Beach, Florida, 32114, United States
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Daytona Beach, Florida, 32117, United States
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Fort Lauderdale, Florida, 33308, United States
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Lakeland, Florida, 33805, United States
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New Port Richey, Florida, 34652, United States
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Plantation, Florida, 33324, United States
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Stuart, Florida, 34994, United States
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Augusta, Georgia, 30901, United States
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Thomasville, Georgia, 31792, United States
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Elmhurst, Illinois, 60126, United States
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Gurnee, Illinois, 60031, United States
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Mount Vernon, Illinois, 62864, United States
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Skokie, Illinois, 60076, United States
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Urbana, Illinois, 61801, United States
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Indianapolis, Indiana, 46237, United States
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South Bend, Indiana, 46601, United States
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Sioux City, Iowa, 51101, United States
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Waterloo, Iowa, 50702, United States
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Hutchinson, Kansas, 67502, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40202, United States
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Mount Sterling, Kentucky, 40353, United States
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Paducah, Kentucky, 42003, United States
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Alexandria, Louisiana, 71301, United States
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Lafayette, Louisiana, 70503, United States
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Marrero, Louisiana, 70072, United States
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Shreveport, Louisiana, 71103, United States
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Cumberland, Maryland, 21502, United States
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Randallstown, Maryland, 21133, United States
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Rockville, Maryland, 20850, United States
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Westminster, Maryland, 21157, United States
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Lowell, Massachusetts, 01854, United States
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Battle Creek, Michigan, 49017, United States
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Duluth, Minnesota, 55805, United States
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Saint Cloud, Minnesota, 56303, United States
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Jackson, Mississippi, 39202, United States
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Jefferson City, Missouri, 65101, United States
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Kansas City, Missouri, 64132, United States
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Saint Joseph, Missouri, 64507, United States
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St Louis, Missouri, 63136, United States
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Billings, Montana, 59101, United States
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Omaha, Nebraska, 68106, United States
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Nashua, New Hampshire, 03060, United States
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Denville, New Jersey, 07834, United States
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East Syracuse, New York, 13057, United States
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Johnson City, New York, 13790, United States
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Gastonia, North Carolina, 28054, United States
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Hickory, North Carolina, 28602, United States
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Pinehurst, North Carolina, 28374, United States
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Massillon, Ohio, 44646, United States
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Zanesville, Ohio, 43701, United States
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Bend, Oregon, 97701, United States
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Bethlehem, Pennsylvania, 18015, United States
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Langhorne, Pennsylvania, 19047, United States
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Florence, South Carolina, 29506, United States
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Watertown, South Dakota, 57201, United States
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Bristol, Tennessee, 37620, United States
Research Site
Chattanooga, Tennessee, 37421, United States
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Corpus Christi, Texas, 78404, United States
Research Site
Corpus Christi, Texas, 78412, United States
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Plano, Texas, 75093, United States
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Ogden, Utah, 84403, United States
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Chesapeake, Virginia, 23320, United States
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Spokane, Washington, 99208, United States
Research Site
Huntington, West Virginia, 25701, United States
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Janesville, Wisconsin, 53548, United States
Research Site
Madison, Wisconsin, 53792, United States
Research Site
Racine, Wisconsin, 53405, United States
Research Site
Wauwatosa, Wisconsin, 53226, United States
Research Site
Weston, Wisconsin, 54476, United States
Related Publications (1)
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.
PMID: 29147854BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 23, 2012
Study Start
November 1, 2012
Primary Completion
March 18, 2015
Study Completion
March 18, 2015
Last Updated
January 30, 2018
Results First Posted
March 9, 2016
Record last verified: 2018-01