Clinical trial · Interventional
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)
NCT03348696CI-TRIAL-00042664REaCT-TAPScompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Pain Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone physician choice | Drug | — | UNRESOLVED |
| Dexamethasone tapering dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- dexamethasone tapering dose
- description
- 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
- interventionNames
- Drug: Dexamethasone tapering dose
- type
- ACTIVE_COMPARATOR
- label
- dexamethasone physician choice
- description
- standard dexamethasone pre-medication (i.e. 8mg B.I.D x 3 days commencing the day before chemotherapy) then physician choice interventions
- interventionNames
- Drug: Dexamethasone physician choice
Primary outcomes (1)
- measure
- Evaluation of TAPS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDClemons 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. PMID 33742240