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NOLAN: Naproxen or Loratadine and Neulasta | Clinical Trials | Clareo Health

COMPLETEDPHASE2

NOLAN: Naproxen or Loratadine and Neulasta

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

NCT01712009•Amgen

View on ClinicalTrials.gov

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.

Detailed Description

In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis. Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.

Eligibility

Age

18 - 100 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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)
+8 more criteria

Locations (83)

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

Key Dates

Start Date

November 1, 2012

Primary Completion Date

March 18, 2015

Completion Date

March 18, 2015

Last Updated

January 30, 2018

Enrollment

600

ACTUAL participants

Conditions

Bone Pain in Stage I - III Breast Cancer

Interventions

Naproxen

DRUG

Loratadine

DRUG

Pegfilgrastim

BIOLOGICAL

Chemotherapy

DRUG