Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim (VINE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01752907
First received: November 15, 2012
Last updated: December 6, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Breast Cancer
Other: General Education DVD
Other: Bone Pain Education DVD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Maximum Patient-reported Bone Pain in Cycle 1 [ Time Frame: Days 1 to 5 during cycle 1. ] [ Designated as safety issue: No ]
    Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.


Secondary Outcome Measures:
  • Maximum Patient-reported Bone Pain by Cycle and Across All Cycles [ Time Frame: Days 1-5 for each treatment cycle ] [ Designated as safety issue: No ]
    Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.

  • Mean Patient-reported Bone Pain by Cycle and Across All Cycles [ Time Frame: Days 1-5 for 4 treatment cycles ] [ Designated as safety issue: No ]
    Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.

  • Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles [ Time Frame: Days 1-5 for 4 treatment cycles ] [ Designated as safety issue: No ]
    Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.

  • Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting [ Time Frame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks ] [ Designated as safety issue: No ]
    Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.

  • Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting [ Time Frame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks. ] [ Designated as safety issue: No ]

    Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following:

    Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.


  • Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles [ Time Frame: From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks. ] [ Designated as safety issue: No ]
    Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.


Enrollment: 304
Study Start Date: January 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: General Education DVD
Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Other: General Education DVD
A general chemotherapy side effects education DVD
Experimental: Bone Pain Education DVD
Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
Other: Bone Pain Education DVD

Detailed Description:

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.

Each patient will receive adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis, beginning in the first cycle and continuing throughout the study period. The study period for this study is the first 4 cycles of chemotherapy. participants can be planning to receive regimens with > 4 cycles, but data will only be collected for the first 4 cycles. The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician. Commercially available pegfilgrastim will be administered according to US Prescribing Information and is considered background therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752907

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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01752907     History of Changes
Other Study ID Numbers: 20110148 
Study First Received: November 15, 2012
Results First Received: December 6, 2015
Last Updated: December 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
Breast cancer
Chemotherapy
Pegfilgrastim
Neulasta
Bone Pain
Education

Additional relevant MeSH terms:
Breast Neoplasms
Mastodynia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2016