Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California
Dates
study started
completion around
Principal Investigator
by Oliver Eng

Description

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.

Details

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.

Keywords

Cancer, Hyperthermia, Fever, Electroacupuncture

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients with known peritoneal disease who are scheduled to undergo Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
  • Age ≥18 years
  • Eastern Cooperative Oncology Group performance status ≤2
  • Patients must have adequate organ and marrow function as defined through laboratory tests
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better (class 2B is defined as having cardiac enlargement but no history of congestive heart failure)
  • Expected survival greater than 9 months
  • Ability to understand and the willingness to sign a written informed consent document

You CAN'T join if...

  • Patients with coexistence of another untreated malignant neoplasm other than basal cell carcinoma of the skin within the last five years
  • Sites of metastases other than loco-regional lymph nodes and peritoneum (ex. Visceral metastases such as liver, lungs, bone, brain)
  • Patients with uncontrolled intercurrent illness
  • Severe needle phobia
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements
  • Known bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)
  • Pacemaker or other electronic metal implants
  • Epilepsy
  • Received acupuncture therapy within the past 3 months prior to study enrollment
  • Patients who are breastfeeding, pregnant or are planning get pregnant during the study period.

Location

  • UCI Health Susan Samueli Integrative Health Institute
    Irvine California 92697 United States

Lead Scientist at UC Irvine

  • Oliver Eng
    Associate Clinical Professor, Surgery, School of Medicine. Authored (or co-authored) 112 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06340906
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated