Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

NCT06340906 | Active Not Recruiting DMC

• 2 other identifiers: 4573UCI 23-29
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (6)

• Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited

  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

  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

  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

  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

  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

  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 Outcomes (4)

• Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30

  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

  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

  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

  All the mean scores will be compared at baseline (before surgery), 1 month post-surgery, and 6 months post-surgery.

Other Outcomes (12)

• Biomarkers - Plasma (pg/mL)

  Blood biomarkers will be measured at baseline, 1 month post-surgery, and 6 months post-surgery.

• Vital Signs - Blood Pressure (mmHg)

  Blood pressure will only be measured at baseline.

• Vital Signs - Heart Rate (bpm)

  Heart rate will only be measured at baseline.

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

Electroacupuncture OTHER

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (2)

UCI Health Susan Samueli Integrative Health Institute

Irvine, California, 92697, United States

Location

University of California Irvine, Health

Orange, California, 92868, United States

Location

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MeSH Terms

Conditions

Neoplasms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Oliver Eng, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single-arm, prospective pilot/feasibility study.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 2, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (2)