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

Early-stage Breast Cancer Clinical Trial

— REaCT-TAPS  

Official title:

A Multi-Centre Randomised Study Comparing Tapering Low Dose Dexamethasone to Other Standard of Care Therapies for Taxane- Associated Pain Syndrome (TAPS) in Breast Cancer Patients (OTT 17-02 REaCT-TAPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348696
• Other study ID #: OTT 17-02
• Status: Completed
• Phase: Phase 4
• Start date: February 28, 2018
• Est. completion date: April 2, 2019

Study information

• Verified date: January 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-stage Breast Cancer
• Pain Syndrome
• Syndrome

Intervention

Drug:
• Dexamethasone tapering dose
dexamethasone standard of care pre-medication + dexamethasone tapering dose
• Dexamethasone physician choice
Dexamethasone standard of care pre-medication + dexamethasone physician choice

Locations

Country	Name	City	State
Canada	Southlake Regional Cancer Centre	Newmarket	Ontario
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life	Quality of Life will be evaluated using the 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)	Time Frame: Days 1,3,5,7 and 3 weeks
Secondary	Quality of Life	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	Time Frame: Days 1,3,5,7 and 3 weeks
Secondary	Pain scores	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)	Time Frame: Days 1,3,5,7 and 3 weeks
Secondary	Use of rescue analgesic	requirement of use of rescue analgesics will be assessed by daily morphine equivalent dosing	Time Frame: Days 1,3,5,7, 3 weeks
Secondary	Symptoms and signs associated with dexamethasone	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)	baseline and Day 7
Secondary	Cost effectiveness	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)	baseline and Day 7