Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT06340906
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Sponsor:
University of California, Irvine
Organization:
Study Overview
Official Title:
Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-12
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, nausea/vomiting, 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 pilot/feasibility 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 s/p 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 s/p 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UCI 23-29 | OTHER | CFCCC | View |