NCT03348696

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early-stage Breast Cancer
• Pain Syndrome

Interventions

Type	Name	Description
DRUG	Dexamethasone tapering dose	dexamethasone standard of care pre-medication + dexamethasone tapering dose
DRUG	Dexamethasone physician choice	Dexamethasone standard of care pre-medication + dexamethasone physician choice

Timeline

• Start date: 2018-02-28
• Primary completion: 2019-04-02
• Completion: 2019-04-02
• First posted: 2017-11-21
• Last updated: 2020-01-09

Locations

2 sites across 1 country: Canada