Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754528
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-07
First Post:
2023-02-08
Brief Title:
Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
A Pragmatic Randomised Trial Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance REaCT-TEMPO
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REaCT-TEMPO
Brief Summary:
The goal of this randomized pragmatic clinical trial is to evaluate an endocrine therapy dose-frequency escalation strategy and its effects on tolerability and compliance Participants will be randomized to standard daily dosing of endocrine therapy or endocrine therapy dose-frequency escalation defined as taking endocrine therapy every other day for 1 month and then daily
Detailed Description:
Breast cancer remains the most common cancer diagnosis and second leading cause of cancer death among Canadian women Close to 70 of breast cancers are hormone-dependent and endocrine therapy is the mainstay treatment such as tamoxifen aromatase inhibitors and lutenizing hormone-releasing hormone analogs Globally endocrine therapy has led to the greatest benefit for breast cancer patients resulting in compelling reductions in breast cancer recurrence and mortality rates Tamoxifen and aromatase inhibitors eg letrozole anastrozole and exemestane can cause a variable degree of toxicity linked to estrogen deprivation such as vasomotor symptoms hot flashes and night sweats arthralgiajoint stiffness genitourinary symptoms vaginal dryness dysuria urinary incontinence recurrent urinary tract infections and pain during sexual intercourse insomnia weight gain mood changes cognitive dysfunction fatigue and skin dryness It is well acknowledged that endocrine therapy side effects can influence treatment adherence compliance and persistence A systematic review of adjuvant endocrine treatment found that 41 to 72 of patients did not take the correct dosage at the prescribed frequency and 31 to 73 discontinued endocrine therapy Treatment adherence and persistence are key issues in breast cancer as early cessation or reduced complianceadherence to hormonal therapy leads to reduced disease-free survival and increased mortality Despite a plethora of studies aimed at reducing the side effects of endocrine therapy there is no clear evidence that any of them have resulted in improved adherencecompliancepersistence In practice it is common to see a clinician reducing dose-intensity or frequency when patients develop intolerable side effects from endocrine therapy ie either using 10 mg instead of 20 mg of Tamoxifen daily or an every other day schedule for aromatase inhibitors However this commonly used practice has not been evaluated in a prospective trial The researchers propose to conduct the worlds first prospective randomized clinical trial to evaluate a dose-frequency escalation strategy of endocrine therapy meaning taking the dose every other day for 1 month and then daily and its effects on adherence and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None