Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162663
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-11-29
Brief Title:
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Investigators propose a double-blind placebo-controlled trial evaluating the use of the use of Suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life Breast cancer survivors have an increased risk of insomnia for which Suvorexant has the has the potential ability to impact to improve sleep related outcomes and cancer survivorship outcomes Breast cancer survivors with sleep disturbance based on an Insomnia Severity Index Score ISI 15 will be randomized to either Suvorexant or placebo with both arms receiving education on sleep hygiene
Detailed Description:
Cancer survivors have an incidence of sleep disturbance and insomnia higher than the general population with significant potential implications on health outcomes including in survivorship domains and mortality outcomes Available pharmacologic options for management of sleep disturbance are limited in efficacy and in their side effects Investigators propose a double-blind placebo-controlled trial evaluating the use of the use of Suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life Evaluation of breast cancer survivors on endocrine therapy uses a study population with high 5-year survival rate while retaining the capacity for recruitment and creating an opportunity to explore potential effects on vasomotor symptoms Suvorexant has the potential to have a significant impact in cancer survivors not only on sleep related outcomes but also on cancer survivorship outcomes
The purpose of the research study is to evaluate the ability of Suvorexant a medication approved by the Food and Drug Administration FDA for insomnia to treat sleep disturbance in breast cancer survivors on endocrine therapy
The purpose of the research study is to evaluate the ability of Suvorexant a medication approved by the Food and Drug Administration FDA for insomnia to treat sleep disturbance in breast cancer survivors on endocrine therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None