Clinical trial NCT06340906: Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Official title: Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm, prospective pilot/feasibility study.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited
timeFrame: Through study completion; approximately 1.5 years.
measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Patient Recruitment Rate
timeFrame: Through study completion; approximately 1.5 years.
measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Reasons for Abstaining from Participation
timeFrame: Through study completion; approximately 1.5 years.
measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Recruitment Duration
timeFrame: Through study completion; approximately 1.5 years.
measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Completed Electroacupuncture Sessions
timeFrame: Through study completion; approximately 1.5 years.
measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Proportion of Completed Electroacupuncture Sessions
timeFrame: Through study completion; approximately 1.5 years.
Secondary outcomes:
measure: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30
timeFrame: All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
measure: Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30
timeFrame: All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
measure: Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3
timeFrame: All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
measure: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3
timeFrame: All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Other outcomes:
measure: Biomarkers - Plasma (pg/mL)
timeFrame: Blood biomarkers will be measured at baseline, 1 month post-surgery, and 6 months post-surgery.
measure: Vital Signs - Blood Pressure (mmHg)
timeFrame: Blood pressure will only be measured at baseline.
measure: Vital Signs - Heart Rate (bpm)
timeFrame: Heart rate will only be measured at baseline.
measure: Vital Signs - Body Temperature (C)
timeFrame: Body temperature will only be measured at baseline.
measure: Vital Signs - Respiration Rate (breaths/minute)
timeFrame: Respiration rate will only be measured at baseline.
measure: Vital Signs - Oxygen Saturation Rate (%)
timeFrame: Oxygen saturation rate will only be measured at baseline.
measure: Height (feet and inches)
timeFrame: Height will only be measured at baseline.
measure: Weight (kg)
timeFrame: Weight will only be measured at baseline.
measure: Incidence of Treatment-Emergent Adverse Events - Safety Monitoring
timeFrame: Through study completion; Approximately 1.5 years
measure: Biomarkers - Plasma BDNF (pg/ml)
timeFrame: Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
measure: Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL)
timeFrame: Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
measure: Mitochondrial DNA content
timeFrame: Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Locations:
city: Irvine
country: United States
facility: UCI Health Susan Samueli Integrative Health Institute
state: California
city: Orange
country: United States
facility: University of California Irvine, Health
state: California
Study officials:
affiliation: University of California, Irvine
name: Oliver Eng, MD
role: PRINCIPAL_INVESTIGATOR
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