NOLAN: Naproxen or Loratadine and Neulasta

Completed · Phase 2

Conditions studied: Bone Pain in Stage I - III Breast Cancer

In brief

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.

Key facts

Study ID

NCT01712009

Run by

Amgen

People needed

600

Starts

2012-11-01

Expected to finish

2015-03-18

Last updated by the study team

2018-01-30

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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 — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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