Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228943
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2005-09-14
Brief Title:
The Role of Serotonin in Hot Flashes After Breast Cancer
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
The Role of Serotonin in Hot Flashes After Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The purpose of this proposal is to improve our understanding of the role of tryptophan and serotonin in hot flashes The main hypothesis is that alterations in tryptophan and serotonin levels are involved in the induction of hot flashes in women with breast cancer and genetic variations in the serotonin receptors and transporters also play a role
Detailed Description:
Among women with breast cancer hot flashes are a frequent severe and bothersome symptom For this group hot flashes are negatively related to mood affect and daily activities and can compromise compliance with life-saving medications eg tamoxifen Over 60 of breast cancer survivors report hot flashes with 59 stating they are extremely severe and 44 reporting them to be extremely bothersome Unfortunately limitations in our understanding of hot flash physiology limit clinicians abilities to fully treat this symptom Although the current non-hormonal treatment of choice for hot flashes after breast cancer targets the central serotonin system eg paroxetine venlafaxine the role of serotonin in hot flashes has not been directly tested Because the effectiveness of these agents has been based largely on improvement in subjective reporting of hot flashes it is not clear whether benefits are due to physiological effects on hot flashes or due to improvements in mood or other related symptoms In addition these and other currently available treatments are not acceptable appropriate or effective for all women with breast cancer Understanding the physiological mechanisms involved in hot flashes after breast cancer will enable us to develop more targeted behavioral andor pharmacological therapies to be used in lieu of or in addition to currently available therapies so that we can eradicate hot flashes and improve the quality of life for women with breast cancer
Results implicating direct effects of tryptophan and serotonin on objective hot flashes will help guide the development of improved interventions for alleviating hot flashes in women with breast cancer These interventions may target the central serotonin system either behaviorally eg diet or pharmacologically eg alternative drug therapeutics If direct manipulation of tryptophan and serotonin does not affect hot flashes these findings will be equally as useful in guiding future research on non-serotonin related etiologies and interventions Findings from this study will ultimately be used to eradicate hot flashes as a frequent severe and bothersome breast cancer treatment related condition thereby improving quality of life for all women with breast cancer
Results implicating direct effects of tryptophan and serotonin on objective hot flashes will help guide the development of improved interventions for alleviating hot flashes in women with breast cancer These interventions may target the central serotonin system either behaviorally eg diet or pharmacologically eg alternative drug therapeutics If direct manipulation of tryptophan and serotonin does not affect hot flashes these findings will be equally as useful in guiding future research on non-serotonin related etiologies and interventions Findings from this study will ultimately be used to eradicate hot flashes as a frequent severe and bothersome breast cancer treatment related condition thereby improving quality of life for all women with breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 043199 | None | None | None |
| DOD-BC043199 | None | None | None |