Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340906
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-02-27
Brief Title:
Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Status:
NOT_YET_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:
None
Brief Summary:
The investigators are conducting this research study is to evaluate the feasibility recruitment compliance safety and acceptance of using electroacupuncture EA to manage complex symptoms such as pain nauseavomiting diarrhea and insomnia in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Additionally the investigators are aiming to determine the effectiveness of EA in reducing these symptoms and to examine how EA impacts important biomarkers or proteins in the blood that can be used as indicators or signs of these symptoms
Detailed Description:
This is a single-arm prospective pilotfeasibility study Patients can be enrolled at any time prior to undergoing surgery The protocol and interventions are as described in the above schema Baseline assessments including the above surveys and inflammatory markers will be obtained at the preoperative visit The same assessments will be performed at approximately 1 month sp Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Electroacupuncture interventions will be performed between postoperative months 1 to 3 a total of 8 weekly interventions will be performed A completion assessment will be performed at approximately 6 months sp Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Our specific aims are as follows
To examine the feasibility of utilizing an EA protocol in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
To characterize symptoms experienced by patients during recovery from Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
To evaluate the utilization of EA in symptom management during recovery from Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
To evaluate levels of biomarkers such as circulating brain-derived neurotrophic factor pro-inflammatory cytokines IL-1beta IL-4 IL-6 IL-8 IL-10 Tumor necrosis factor-alpha mitochondrial DNA after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy and with utilization of EA
Our specific aims are as follows
To examine the feasibility of utilizing an EA protocol in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
To characterize symptoms experienced by patients during recovery from Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
To evaluate the utilization of EA in symptom management during recovery from Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
To evaluate levels of biomarkers such as circulating brain-derived neurotrophic factor pro-inflammatory cytokines IL-1beta IL-4 IL-6 IL-8 IL-10 Tumor necrosis factor-alpha mitochondrial DNA after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy and with utilization of EA
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCI 23-29 | OTHER | CFCCC | None |