Early-stage Breast CancerPhase 4REaCT-TAPSNCT03348696
Comparing Tapering Low Dose Dexamethasone to Other Standard of Care Therapies for TAPS in Breast Cancer Patients
A Phase 4 study testing Dexamethasone tapering dose and Dexamethasone physician choice in people with Early-stage Breast Cancer and Pain Syndrome, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Early-stage Breast Cancer, Pain Syndrome
- What is being tested?
- Dexamethasone tapering dose and Dexamethasone physician choice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Feb 2018to 2 Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Southlake Regional Cancer Centre
Newmarket, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, k1H 8L6
About this study
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)
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.
Read the 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
- Being tested
- Dexamethasone tapering dose, Dexamethasone physician choice
- Medical subject headings
- Breast Neoplasms, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone tapering doseDrug
Also called dexamethasone sodium phosphate, dexamethasone acetate
dexamethasone standard of care pre-medication + dexamethasone tapering dose
Dexamethasone physician choiceDrug
Also called dexamethasone sodium phosphate, dexamethasone acetate
Dexamethasone standard of care pre-medication + dexamethasone physician choice
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone tapering dose | Active comparator | 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 Receives: Drug: Dexamethasone tapering dose |
| dexamethasone physician choice | Active comparator | standard dexamethasone pre-medication (i.e. 8mg B.I.D x 3 days commencing the day before chemotherapy) then physician choice interventions Receives: Drug: Dexamethasone physician choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change in TAPS from Days 1-7, 3 weeks
Secondary outcomes (6)
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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start28 Feb 2018
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Clemons, MD, Principal investigator, Ottawa Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348696
- Sponsor's protocol ID
- OTT 17-02
- Acronym
- REaCT-TAPS
- Status last verified
- Jan 2020
- First submitted
- 27 Sep 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33742240
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03348696
- Acronym / sponsor ID
- REaCT-TAPS / OTT 17-02
- Conditions
- Early-stage Breast Cancer, Pain Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone tapering dose | Active comparator | Drug: Dexamethasone tapering dosestandard 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 |
| dexamethasone physician choice | Active comparator | Drug: Dexamethasone physician choicestandard dexamethasone pre-medication (i.e. 8mg B.I.D x 3 days commencing the day before chemotherapy) then physician choice interventions |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone tapering doseAlso: dexamethasone sodium phosphate, dexamethasone acetatedexamethasone standard of care pre-medication + dexamethasone tapering dose | Drug | dexamethasone tapering dose |
| Dexamethasone physician choiceAlso: dexamethasone sodium phosphate, dexamethasone acetateDexamethasone standard of care pre-medication + dexamethasone physician choice | Drug | dexamethasone physician choice |
Primary outcome
Evaluation of TAPS
Time frame: 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)
6 secondary outcomes
Quality of Life
Time frame: Time Frame: Days 1,3,5,7 and 3 weeks
Quality of Life
Time frame: Time Frame: Days 1,3,5,7 and 3 weeks
Pain scores
Time frame: Time Frame: Days 1,3,5,7 and 3 weeks
Use of rescue analgesic
Time frame: Time Frame: Days 1,3,5,7, 3 weeks
Symptoms and signs associated with dexamethasone
Time frame: baseline and Day 7
Cost effectiveness
Time frame: baseline and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Derived from this study: PubMed 33742240Clemons 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.
- Individual participant dataSharing planned: No
Related trials for Early-stage Breast Cancer
RecruitingObservational study
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Early-stage HER2+ Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Clemons, MD principal investigator
Ottawa Hospital Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone tapering dose and Dexamethasone physician choice in people with Early-stage Breast Cancer and Pain Syndrome, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of TAPS (time frame: Change in TAPS from Days 1-7, 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.