Early-stage Breast Cancer, Pain Syndrome
Conditions
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.
Interventions
DRUGDexamethasone tapering dose
dexamethasone standard of care pre-medication + dexamethasone tapering dose
DRUGDexamethasone physician choice
Dexamethasone standard of care pre-medication + dexamethasone physician choice
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Canada
Outcome results
None listed