Clinical trial NCT03348696: Comparing Tapering Low Dose Dexamethasone to Other Standard of Care Therapies for TAPS in Breast Cancer Patients
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Early-stage Breast Cancer
Pain Syndrome
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 124
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of TAPS
timeFrame: Change in TAPS from Days 1-7, 3 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: Time Frame: Days 1,3,5,7 and 3 weeks
measure: Quality of Life
timeFrame: Time Frame: Days 1,3,5,7 and 3 weeks
measure: Pain scores
timeFrame: Time Frame: Days 1,3,5,7 and 3 weeks
measure: Use of rescue analgesic
timeFrame: Time Frame: Days 1,3,5,7, 3 weeks
measure: Symptoms and signs associated with dexamethasone
timeFrame: baseline and Day 7
measure: Cost effectiveness
timeFrame: baseline and Day 7
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: Ottawa Hospital Cancer Centre
name: Mark Clemons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clemons M, Simos D, Sienkiewicz M, Ng T, Zibdawi L, Basulaiman B, Awan A, Fergusson D, Vandermeer L, Saunders D, Hutton B, Amir E; REThinking Clinical Trials (REaCT) Investigators. A prospective multi-centre, randomized study comparing the addition of tapering dexamethasone to other standard of care therapies for taxane-associated pain syndrome (TAPS) in breast cancer patients. Support Care Cancer. 2021 Oct;29(10):5787-5795. doi: 10.1007/s00520-021-06142-8. Epub 2021 Mar 19.