Bone Pain in Stage I - III Breast Cancer | NOLAN: Naproxen or Loratadine and Neulasta
Bone Pain in Stage I - III Breast Cancer research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Age 18 years or over - Eastern cooperative oncology group (ECOG) performance status 0-2 - Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer - Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy, pegfilgrastim, naproxen and loratadine as determined by the investigator - Creatinine ≤ 1.5 X upper limit of normal (ULN) - 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 - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Bone Pain in Stage I - III Breast Cancer
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:PegfilgrastimCommercially 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.
Drug:ChemotherapyThe choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Prophylactic naproxenParticipants 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 loratadineParticipants 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 treatmentParticipants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
Start Date: November 2012
Completed Date: March 2015
Phase: Phase 2
Primary Outcome: Percentage of Participants With Bone Pain (All Grades) in Cycle 1
Secondary Outcome: Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles
Study sponsors, principal investigator, and references
Principal Investigator: MD
Lead Sponsor: Amgen