Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

April 1, 2024 updated by: Oliver Eng, University of California, Irvine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Alexandre Chan, PharmD
  • Phone Number: (949) 824-8896
  • Email: a.chan@uci.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Each participant will attend a total of 8 treatment visits (one visit per week), over the course of 8 weeks. Each EA session will be approximately 1 hour. Participants in the treatment arm will receive EA at 10 standardized acu-points that were chosen for their therapeutic effects.
Other: Electroacupuncture
EA at 10 standardized acu-points that were chosen for their therapeutic effects: Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6), Shenmen (HT7), Hegu (LI4) bilateral, Zusanli (ST36), Sanyinjiao (SP6), Zhaohai (KI6), Taichong (LR3) bilateral, Tian Shu (ST25) bilateral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited
Time Frame: Through study completion; approximately 1.5 years.
The feasibility of utilizing an EA protocol in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy will be assessed through the number of participants recruited (% of target recruitment).
Through study completion; approximately 1.5 years.
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Patient Recruitment Rate
Time Frame: Through study completion; approximately 1.5 years.
The feasibility of utilizing an EA protocol in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy will be assessed through assessing the number of patients recruited per month.
Through study completion; approximately 1.5 years.
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Reasons for Abstaining from Participation
Time Frame: Through study completion; approximately 1.5 years.
The feasibility of utilizing an EA protocol in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy will be assessed through assessing the reasons both active and potential participants declined participation.
Through study completion; approximately 1.5 years.
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Recruitment Duration
Time Frame: Through study completion; approximately 1.5 years.
The feasibility of utilizing an EA protocol in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy will be assessed through the time spent on recruitment, in minutes.
Through study completion; approximately 1.5 years.
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Completed Electroacupuncture Sessions
Time Frame: Through study completion; approximately 1.5 years.
The feasibility of utilizing an EA protocol in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy will be assessed through patient adherence to the study procedures through assessing the number of electroacupuncture sessions successfully completed in total.
Through study completion; approximately 1.5 years.
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Proportion of Completed Electroacupuncture Sessions
Time Frame: Through study completion; approximately 1.5 years.
The feasibility of utilizing an EA protocol in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy will be assessed through patient adherence to the study procedures through assessing the proportion of participants completing all the scheduled electroacupuncture sessions.
Through study completion; approximately 1.5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30
Time Frame: All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.

The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30) is a validated questionnaire developed to assess cancer patients' health-related quality of life. It incorporates 5 functional scales (cognitive, emotional, physical, role, and social), symptom scales (e.g. pain, fatigue, insomnia), and a global health scale. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale. Higher scores represent a better global health status and better degree of functioning while lower symptom scores indicate less severe symptoms.

In addition to this questionnaire, patients' clinical notes will be reviewed to better characterize the respective symptoms.
All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30
Time Frame: All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30) is a validated questionnaire developed to assess cancer patients' health-related quality of life. It incorporates 5 functional scales (cognitive, emotional, physical, role, and social), symptom scales (e.g. pain, fatigue, insomnia), and a global health scale. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale. Higher scores represent a better global health status and better degree of functioning while lower symptom scores indicate less severe symptoms.
All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3
Time Frame: All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
All subjects will complete the FACT-Cog version 3 questionnaire to assess self-perceived subjective cognitive function. FACT-Cog is a validated questionnaire containing 33 items in the domains of concentration, functional interference, mental acuity, memory, multitasking and verbal fluency. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning.
All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3
Time Frame: All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.

All subjects will complete the FACT-Cog version 3 questionnaire to assess self-perceived subjective cognitive function. FACT-Cog is a validated questionnaire containing 33 items in the domains of concentration, functional interference, mental acuity, memory, multitasking and verbal fluency. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning.

This questionnaire will be utilized to better characterize the effects Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy on cognitive function. of In addition to this questionnaire, patients' clinical notes will be reviewed for more robust characterization of the symptoms.
All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers - Plasma (pg/mL)
Time Frame: Blood biomarkers will be measured at baseline, 1 month post-surgery, and 6 months post-surgery.
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.
Blood biomarkers will be measured at baseline, 1 month post-surgery, and 6 months post-surgery.
Vital Signs - Heart Rate (bpm)
Time Frame: Heart rate will only be measured at baseline.
The heart rate of each patient will be measured prior to surgery as part of the screening process for eligibility for participation. This is to ensure the patient's stability in both undergoing the surgery and EA.
Heart rate will only be measured at baseline.
Vital Signs - Body Temperature (C)
Time Frame: Body temperature will only be measured at baseline.
The body temperature of each patient will be measured prior to surgery as part of the screening process for eligibility for participation. This is to ensure the patient's stability in both undergoing the surgery and EA.
Body temperature will only be measured at baseline.
Vital Signs - Respiration Rate (breaths/minute)
Time Frame: Respiration rate will only be measured at baseline.
The respiration rate of each patient will be measured prior to surgery as part of the screening process for eligibility for participation. This is to ensure the patient's stability in both undergoing the surgery and EA.
Respiration rate will only be measured at baseline.
Vital Signs - Oxygen Saturation Rate (%)
Time Frame: Oxygen saturation rate will only be measured at baseline.
The oxygen saturation rate of each patient will be measured prior to surgery as part of the screening process for eligibility for participation. This is to ensure the patient's stability in both undergoing the surgery and EA.
Oxygen saturation rate will only be measured at baseline.
Height (feet and inches)
Time Frame: Height will only be measured at baseline.
The participant's height will be measured prior to surgery to ensure anesthesia dosage required for the procedure is accurate to prevent any associated risk of complications during the surgery.
Height will only be measured at baseline.
Weight (kg)
Time Frame: Weight will only be measured at baseline.
The participant's weight will be measured prior to surgery to ensure anesthesia dosage required for the procedure is accurate to prevent any associated risk of complications during the surgery.
Weight will only be measured at baseline.
Incidence of Treatment-Emergent Adverse Events - Safety Monitoring
Time Frame: Through study completion; Approximately 1.5 years
Participants will be monitored for adverse events such as bruising, pain or discomfort, bleeding and possible infections. Severity are graded according to the Common Terminology Criteria for Adverse Events V5.
Through study completion; Approximately 1.5 years
Biomarkers - Plasma BDNF (pg/ml)
Time Frame: Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Plasma brain-derived neurotropic factor (BDNF) levels at each time point, and changes from baseline.
Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL)
Time Frame: Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Plasma cytokine levels at each time point, and changes from baseline.
Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Mitochondrial DNA content
Time Frame: Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Mitochondrial DNA (mtDNA) content at each time point, and changes from baseline
Baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.
Vital Signs - Blood Pressure (mmHg)
Time Frame: Blood pressure will only be measured at baseline.
The systolic and diastolic blood pressure of each patient will be measured prior to surgery as part of the screening process for eligibility for participation. This is to ensure the patient's stability in both undergoing the surgery and EA.
Blood pressure will only be measured at baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4573
  • UCI 23-29 (Other Identifier: CFCCC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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