Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04781959
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Early-stage Breast Cancer Drug: Filgrastim Drug: Pegfilgrastim Phase 4

Detailed Description:
The use of granulocyte colony-stimulating factors (G-CSF) significantly reduces febrile neutropenia (FN) risk and has helped maintain dose intensity and dose density when treating breast cancer with chemotherapy. This is crucial as survival outcomes are significantly impaired if dose intensity are reduced. National and international guidelines recommend the use of G-CSF as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) as a G-CSF that has been in use since the early 90s. Pegfilgrastim (PEG) is a long-acting, pegylated version of FIL that requires only one injection per chemotherapy cycle instead of daily FIL injections for 5 to 10 days per cycle. PEG and FIL both come at the potential cost of bone pain, the most common side effect. G-CSF related bone pain is often severe, leading to refusal or cancellation of G-CSF and early discontinuation of chemotherapy. We propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy (REaCT-5G)
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Active Comparator: 5 Days of Filgrastim
Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy.
Drug: Filgrastim
Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy
Other Name: Neupogen

Active Comparator: Pegfilgrastim
Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy
Drug: Pegfilgrastim
Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy
Other Name: Neulasta




Primary Outcome Measures :
  1. Bone pain [ Time Frame: 5 days after first G-CSF injection ]
    Bone pain over the first 5 days after the administration of G-CSF. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) based on a patient's daily pain score, starting after the first dose of G-CSF injection.


Secondary Outcome Measures :
  1. Incidence of Febrile Neutropenia [ Time Frame: 2.5 years after study initiation ]
    Number of times participants have Febrile neutropenia during chemotherapy treatment

  2. Incidence of treatment-related hospitalizations [ Time Frame: 2.5 years after study initiation ]
    Number of times participants have a treatment-related hospitalization

  3. Incidence of chemotherapy alteration [ Time Frame: 2.5 years after study initiation ]
    Number of times participants have a chemotherapy alteration including: dose delay, reduction and/or discontinuation

  4. Incidence of chemotherapy-related mortality [ Time Frame: 2.5 years after study initiation ]
    Number of times there is a chemotherapy-related mortality

  5. Rate of G-CSF compliance as prescribed [ Time Frame: 2.5 years after study initiation ]
    Number of times there is a G-CSF compliance

  6. Differences in healthcare resource utilization [ Time Frame: 2.5 years after study initiation ]
    Differences in healthcare resource utilization: number of emergency room visits, number of planned/unplanned provider clinic visits (including stretcher bay), patient-reported phone calls or email to patient support line or provider, and additional medication use or management strategies related to G-CSF side effects or efficacy

  7. HR-QoL [ Time Frame: 2.5 years after study initiation ]
    HR-QoL based on EQ-5D-5L

  8. Cost-effectiveness [ Time Frame: 2.5 years after study initiation ]
    Cost differences associated with prescribing Filgrastim and Pegfilgrastim

  9. Patient G-CSF preference [ Time Frame: 2.5 years after study initiation ]
    To survey patient preference in selection of G-CSF treatment before and after undergoing chemotherapy and G-CSF treatment

  10. Study feasibility [ Time Frame: 1 year after study initiation ]
    Interim analysis/feasibility. After the first year of study initiation, if study recruitment is less than 30% at one year (70 patients), or if there are unanticipated safety issues, a review of study conduct will be performed to consider stopping the study unless there are unexpected or exceptional reasons, or in the case of low recruitment, there is a plan to boost recruitment efforts



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
  • Able to provide verbal consent
  • Able to complete questionnaires in English or French

Exclusion Criteria:

  • No access to pegfilgrastim or filgrastim prior to randomization
  • Metastatic cancer
  • Known hypersensitivity to filgrastim or pegfilgrastim or one of its components

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781959


Contacts
Layout table for location contacts
Contact: Lisa Vandermeer 6137377700 ext 73039 lvandermeer@toh.ca
Contact: Carol Stober 6137377700 ext 77226 cstober@ohri.ca

Locations
Layout table for location information
Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada
Contact: Lisa Vandermeer    613-737-7700 ext 73039    lvandermeer@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Terry Ng, MD Ottawa Hospital Research Institute
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04781959    
Other Study ID Numbers: REaCT-5G
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Filgrastim
Pegfilgrastim
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs