Phase 2
N=304
Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01752907 ↗Enrolled (actual)
304
Serious AEs
12.0%
Results posted
Jan 2016
Primary outcome: Primary: Maximum Patient-reported Bone Pain in Cycle 1 — 3.2; 3.5 units on a scale — p=0.3479
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- General Education DVD (Other); Bone Pain Education DVD (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Patient-reported Bone Pain in Cycle 1 |
3.2; 3.5 | 0.3479 |
| SECONDARY Maximum Patient-reported Bone Pain by Cycle and Across All Cycles |
2.5; 2.7; 2.7; 2.6; 2.4; 2.5 | — |
| SECONDARY Mean Patient-reported Bone Pain by Cycle and Across All Cycles |
1.6; 1.8; 1.3; 1.5; 1.4; 1.4 | — |
| SECONDARY Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles |
6.7; 7.6; 5.4; 6.3; 6.2; 6.1 | — |
| SECONDARY Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting |
43.0; 40.4; 37.2; 35.4; 37.3; 35.3 | — |
| SECONDARY Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting |
2.0; 5.3; 0.0; 2.1; 0.0; 2.2 | — |
| SECONDARY Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles |
74.5; 73.5; 69.0; 65.3; 65.5; 66.2 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01752907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.