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Study Complete
Sponsor ID
20110148

Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and PegfilgrastimVINE

Sponsor ID
20110148
Clinicaltrials.gov ID
NCT01752907
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to determine if patient education can affect patient reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim.

Additional Study Details

Phase
Phase 2
Product
pegfilgrastim
Type
Interventional
Masking
Single (Investigator)
Enrollment
304
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum subject-reported bone pain in cycle 1

Timeframe: up to 20 weeks

Secondary Outcome Measures

Maximum subject-reported bone pain by cycle (2 through 4) and across cycles (up to and including 4 cycles)

Timeframe: up to 20 weeks

Subject-reported bone pain by cycle and across cycles (up to and including 4 cycles)

Timeframe: up to 20 weeks

AUC for subject-reported bone pain by cycle and across all cycles (up to and including 4 cycles)

Timeframe: up to 20 weeks

Bone pain (all grade) by cycle and across cycles (up to and including 4 cycles) captured as part of AE reporting

Timeframe: up to 20 weeks

Severe (grade 3/4) bone pain by cycle and across cycles (up to and including 4 cycles) captured as part of AE reporting

Timeframe: up to 20 weeks

Use of analgesics for the treatment of bone pain by cycle and across cycles (up to and including 4 cycles)

Timeframe: up to 20 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Bristol, TN, United States, 37620
Status
Recruiting
Location
Research Site
Santa Rosa, CA, United States, 95403
Status
Completed
Location
Research Site
Mission Hills, CA, United States, 91345
Status
Recruiting
Location
Research Site
Goldsboro, NC, United States, 27534
Status
Recruiting
Location
Research Site
Morristown, NJ, United States, 07960
Status
Recruiting
Location
Research Site
Gettysburg, PA, United States, 17325
Status
Completed
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Study Info
Age
18 - 99 Years
Condition
  • Breast Cancer
    • Sex
    Assigned Female at Birth
    Trial Dates
    Jan 2013 - Dec 2014
    Inclusion and Exclusion Criteria
    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 • 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 oral non-steroidal anti-inflammatory drugs (NSAIDs) or oral antihistamines with the following exception: - Chronic oral aspirin use for cardiovascular-related indications • 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 taxanes, and use of anti-emetics is allowed, per usual clinical practice. • Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis • Prior use of granulocyte-colony stimulating factor (G-CSF) • 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