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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Early-stage Breast Cancer, Pain Syndrome

Intervention / Treatment
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* Drug: Dexamethasone tapering dose
* Drug: Dexamethasone physician choice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone tapering dose<br>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<br>* dexamethasone standard of care pre-medication + dexamethasone tapering dose<br>* Other names: dexamethasone acetate;|
| Active Comparator: dexamethasone physician choice<br>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<br>* Dexamethasone standard of care pre-medication + dexamethasone physician choice<br>* Other names: dexamethasone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |