Comparing Tapering Low Dose Dexamethasone to Other Standard of Care Therapies for TAPS in Breast Cancer Patients

Phase 4

Completed

• Conditions: Early-stage Breast Cancer; Pain Syndrome
• Interventions: Drug: Dexamethasone physician choice; Drug: Dexamethasone tapering dose

• Registration Number: NCT03348696
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Taxanes such as docetaxel and paclitaxel are widely used chemotherapeutic agents in patients with early stage breast cancer and is commonly associated with taxane-associated pain syndrome (TAPS). TAPS is characterized by disabling pain which usually starts a few days after taxane administration and lasting 2-5 days, often returning following subsequent chemotherapy treatments. TAPS can significantly reduce a patients quality of life, lead to requirements for potent analgesics, as well as dose reductions/delays or discontinuation of chemotherapy. There is currently no clinical guidelines for the optimal standard of care for the management and prevention of TAPS. This REaCT clinical trial investigates the optimal management of TAPS with a tapering dose of dexamethasone (standard premedication comprising 8mg twice daily for 3 days followed by 4mg once a day for 2 days followed by 2mg once a day for 2 days) compared to other standard of care management (i.e. standard premedication with 8mg dexamethasone twice daily for 3 days) as directed by the treating physician. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process.

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Study Start: 2018-02-28
• Primary Completion: 2019-04-02
• Study Completion: 2019-04-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evaluation of TAPS	Change in TAPS from Days 1-7, 3 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness	baseline and Day 7	Incremental cost, incremental quality-adjusted life years (QALYs) and incremental cost effectiveness will be be evaluated using the EuroQol (EQ)-5D-5L questionnaire. This scale evaluates quality of life (mobility, self-care, pain/discomfort, anxiety) on a scale of 1 (no problem)-5 (severe problem)
Quality of Life	Time Frame: Days 1,3,5,7 and 3 weeks	Quality of Life will be evaluated using the Memorial Symptom Assessment Scale (MSAS) which measures prevalence (scale 1 (rarely) to 4 (almost constantly), severity (scale 1(slight) to 4 (very severe)) and level of distress (scale 0 (none) to 4 (very much)) of symptoms on a scale of 1-4
Pain scores	Time Frame: Days 1,3,5,7 and 3 weeks	Pain scores will be evaluated using the Brief Pain Inventory (BPI), which assesses the severity of pain on a scale of 1 (no pain) to 10 (worst pain imaginable), and relief of pain treatments on a scale of 0% (no relief) to 100% (complete relief)
Use of rescue analgesic	Time Frame: Days 1,3,5,7, 3 weeks	requirement of use of rescue analgesics will be assessed by daily morphine equivalent dosing
Symptoms and signs associated with dexamethasone	baseline and Day 7	this will be evaluated using the dexamethasone questions of the FACT-T questionnaire which asks questions specific to symptoms associated with dexamethasone on a scale of 0 (not at all) to 4 (very much)

Trial Locations

Locations (2)

Southlake Regional Cancer Centre; 🇨🇦 Newmarket, Ontario, Canada

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada