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Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim


In this study, the effect of patient education on reported bone pain in breast cancer
patients receiving adjuvant or neoadjuvant chemotherapy and pegfilgrastim will be
investigated.


Inclusion Criteria:



- Age 18 years or over

- ECOG performance status 0-2

- Female with newly diagnosed, not previously treated with chemotherapy, stage I-III
breast cancer

- Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy

- Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy and
pegfilgrastim as determined by the investigator

- Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and
continuing throughout each chemotherapy cycle of the study period

- Has provided informed consent

- Able to understand the content of the DVD material, in investigator's opinion

- Able to read and understand English

Exclusion Criteria:

- Planning to receive weekly chemotherapy

- Chronic use of NSAIDs or anti-histamines

- 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 steroid use. Premedication related to the administration of taxanes, and use
of anti-emetics is allowed, per usual clinical practice

- Prior chemotherapy treatment

- Prior use of G-CSF

- Currently enrolled in another investigational device or drug study, or less than 30
days since ending another investigational device or drug study(s), or receiving other
investigational agent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Maximum subject-reported bone pain in cycle 1

Outcome Description:

To estimate the difference between arms in mean maximum severity of subject-reported bone pain in cycle 1

Outcome Time Frame:

up to 20 weeks

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20110148

NCT ID:

NCT01752907

Start Date:

January 2013

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Chemotherapy
  • Pegfilgrastim
  • Neulasta
  • Bone Pain
  • Education
  • Breast Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteAmes, Iowa  
Research SiteBeverly, Massachusetts  
Research SiteBranson, Missouri  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteChattanooga, Tennessee  
Research SiteAbington, Virginia