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

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03348696

Collaborator

(none)

124

Enrollment

Locations

Arms

13.1

Actual Duration (Months)

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early-stage Breast Cancer Pain Syndrome	Drug: Dexamethasone tapering dose Drug: Dexamethasone physician choice	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Feb 28, 2018

Actual Primary Completion Date :

Apr 2, 2019

Actual Study Completion Date :

Apr 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Dexamethasone tapering dose dexamethasone standard of care pre-medication + dexamethasone tapering dose Other Names: dexamethasone sodium phosphate dexamethasone acetate
Active Comparator: 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	Drug: Dexamethasone physician choice Dexamethasone standard of care pre-medication + dexamethasone physician choice Other Names: dexamethasone sodium phosphate dexamethasone acetate

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Dexamethasone tapering dose

dexamethasone standard of care pre-medication + dexamethasone tapering dose

Other Names:

dexamethasone sodium phosphate

dexamethasone acetate

Active Comparator: 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

Drug: Dexamethasone physician choice

Dexamethasone standard of care pre-medication + dexamethasone physician choice

Other Names:

dexamethasone sodium phosphate

dexamethasone acetate

Outcome Measures

Primary Outcome Measures

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

Quality of Life [Time Frame: Days 1,3,5,7 and 3 weeks]
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)
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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.