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NCT Number: NCT06340906

Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCI Health Susan Samueli Integrative Health Institute, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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