NCT03348696

Brief Summary

The REaCT TAPS clinical trial will compare a tapering dose of dexamethasone to other standards of care on the presence of taxane-associated pain syndrome (TAPS) in early stage breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

September 27, 2017

Last Update Submit

January 6, 2020

Conditions

Early-stage Breast CancerPain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Evaluation of TAPS

    TAPS will be evaluated using the validated Functional Assessment of Cancer Therapy (FACT)-Taxane questionnaire which rates physical, social/family, emotional and functional well being on a scale of 0 (not at all) to 4 (very much)

    Change in TAPS from Days 1-7, 3 weeks

Secondary Outcomes (6)

  • Quality of Life

    Time Frame: Days 1,3,5,7 and 3 weeks

  • Quality of Life

    Time Frame: Days 1,3,5,7 and 3 weeks

  • Pain scores

    Time Frame: Days 1,3,5,7 and 3 weeks

  • Use of rescue analgesic

    Time Frame: Days 1,3,5,7, 3 weeks

  • Symptoms and signs associated with dexamethasone

    baseline and Day 7

  • +1 more secondary outcomes

Study Arms (2)

dexamethasone tapering dose

ACTIVE COMPARATOR

standard dexamethasone pre-medication (8mg B.I.D x 3 days commencing the day before chemotherapy) then 4mg 1x/d for 2 days followed by 2mg 1x/d for 2 days

Drug: Dexamethasone tapering dose

dexamethasone physician choice

ACTIVE COMPARATOR

standard dexamethasone pre-medication (i.e. 8mg B.I.D x 3 days commencing the day before chemotherapy) then physician choice interventions

Drug: Dexamethasone physician choice

Interventions

Dexamethasone tapering doseDRUG

dexamethasone standard of care pre-medication + dexamethasone tapering dose

Also known as: dexamethasone sodium phosphate, dexamethasone acetate
dexamethasone tapering dose
Dexamethasone physician choiceDRUG

Dexamethasone standard of care pre-medication + dexamethasone physician choice

Also known as: dexamethasone sodium phosphate, dexamethasone acetate
dexamethasone physician choice

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving docetaxel-based chemotherapy (Docetaxel 75mg/m2 and cyclophosphamide once every 21 days; or Docetaxel 75mg/m2 and carboplatin and trastuzumab once every 21 days or Fluoro-uracil, epirubicin and cyclophosphamide for 3 cycles once every 21 days, then docetaxel 100mg/m2 once every 21 days; or Adriamycin and cyclophosphamide for 3 cycles, then docetaxel 100mg/m2 once every 21 days) for early stage breast cancer.
  • English literacy and ability to complete questionnaire
  • ≥19 years of age

You may not qualify if:

  • Contraindication to dexamethasone
  • Unable to give informed consent
  • Prior receipt of taxane-based chemotherapy
  • Patient has a significant emotional or psychiatric disorder that in the opinion of the investigator precludes study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Southlake Regional Cancer Centre

Newmarket, Ontario, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, k1H 8L6, Canada

Location

Related Publications (1)

  • Clemons M, Simos D, Sienkiewicz M, Ng T, Zibdawi L, Basulaiman B, Awan A, Fergusson D, Vandermeer L, Saunders D, Hutton B, Amir E; REThinking Clinical Trials (REaCT) Investigators. A prospective multi-centre, randomized study comparing the addition of tapering dexamethasone to other standard of care therapies for taxane-associated pain syndrome (TAPS) in breast cancer patients. Support Care Cancer. 2021 Oct;29(10):5787-5795. doi: 10.1007/s00520-021-06142-8. Epub 2021 Mar 19.

    PMID: 33742240DERIVED

MeSH Terms

Conditions

Breast NeoplasmsSomatoform Disorders

Interventions

dexamethasone 21-phosphatedexamethasone acetate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Study Officials

  • Mark Clemons, MD

    Ottawa Hospital Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

November 21, 2017

Study Start

February 28, 2018

Primary Completion

April 2, 2019

Study Completion

April 2, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)