RECRUITING

Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

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Conditions

Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Quick Facts

Study Start:2024-09-01
Study Completion:2026-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06340906

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with known peritoneal disease who are scheduled to undergo Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
  2. * Age ≥18 years
  3. * Eastern Cooperative Oncology Group performance status ≤2
  4. * Patients must have adequate organ and marrow function as defined through laboratory tests
  5. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  6. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  7. * 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
  8. * 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
  9. * 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)
  10. * Expected survival greater than 9 months
  11. * Ability to understand and the willingness to sign a written informed consent document
  1. * Patients with coexistence of another untreated malignant neoplasm other than basal cell carcinoma of the skin within the last five years
  2. * Sites of metastases other than loco-regional lymph nodes and peritoneum (ex. Visceral metastases such as liver, lungs, bone, brain)
  3. * Patients with uncontrolled intercurrent illness
  4. * Severe needle phobia
  5. * Patients with psychiatric illness/social situations that would limit compliance with study requirements
  6. * Known bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)
  7. * Pacemaker or other electronic metal implants
  8. * Epilepsy
  9. * Received acupuncture therapy within the past 3 months prior to study enrollment
  10. * Patients who are breastfeeding, pregnant or are planning get pregnant during the study period.

Contacts and Locations

Study Contact

Oliver Eng, MD
CONTACT
(714) 456-8000
oeng@hs.uci.edu
Alexandre Chan, PharmD
CONTACT
(949) 824-8896
a.chan@uci.edu

Principal Investigator

Oliver Eng, MD
PRINCIPAL_INVESTIGATOR
University of California, Irvine

Study Locations (Sites)

UCI Health Susan Samueli Integrative Health Institute
Irvine, California, 92697
United States
University of California Irvine, Health
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Oliver Eng, MD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

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 Registration Dates

Study Start Date2024-09-01
Study Completion Date2026-01-30

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2026-01-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer