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

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ClinicalTrials.gov Identifier: NCT03348696
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Early-stage Breast Cancer Pain Syndrome Drug: Dexamethasone tapering dose Drug: Dexamethasone physician choice Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: dexamethasone tapering dose
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
Drug: Dexamethasone tapering dose
dexamethasone standard of care pre-medication + dexamethasone tapering dose
Other Names:
  • dexamethasone sodium phosphate
  • dexamethasone acetate

Active Comparator: dexamethasone physician choice
standard dexamethasone pre-medication (i.e. 8mg B.I.D x 3 days commencing the day before chemotherapy) then physician choice interventions
Drug: Dexamethasone physician choice
Dexamethasone standard of care pre-medication + dexamethasone physician choice
Other Names:
  • dexamethasone sodium phosphate
  • dexamethasone acetate




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 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)

  2. Quality of Life [ Time Frame: Time Frame: Days 1,3,5,7 and 3 weeks ]
    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

  3. Pain scores [ Time Frame: 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)

  4. Use of rescue analgesic [ Time Frame: Time Frame: Days 1,3,5,7, 3 weeks ]
    requirement of use of rescue analgesics will be assessed by daily morphine equivalent dosing

  5. Symptoms and signs associated with dexamethasone [ Time Frame: 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)

  6. Cost effectiveness [ Time Frame: 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)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348696


Contacts
Contact: Mark Clemons, MD 613-737-7700 ext 70170 mclemons@toh.ca

Locations
Canada, Ontario
Southlake Regional Cancer Centre Recruiting
Newmarket, Ontario, Canada
Contact: Liia Catreau       lcatreau@southlakeregional.ca   
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, k1H 8L6
Contact: Brianne Bota, PhD    737-7700 x 79425    bbota@ohri.ca   
Contact: Lisa Vandermeer, MSc       lvandermeer@ohri.ca   
Principal Investigator: Mark Clemons, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Mark Clemons, MD Ottawa Hospital Cancer Centre

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03348696     History of Changes
Other Study ID Numbers: OTT 17-02
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Syndrome
Breast Neoplasms
Disease
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action