Using electroacupuncture to manage symptoms after cancer surgery and chemotherapy
Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
This study is testing if electroacupuncture can help people manage pain, nausea, diarrhea, and insomnia after cancer surgery and chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 2 sites (Irvine, California and 1 other locations) |
| Trial ID | NCT06340906 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and effectiveness of electroacupuncture (EA) in managing complex symptoms such as pain, nausea, diarrhea, and insomnia in patients recovering from Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. It is a single-arm, prospective pilot study where patients will receive eight weekly EA sessions between one to three months post-surgery. Baseline assessments will be conducted prior to surgery, with follow-up assessments at one month and six months post-surgery to evaluate symptom management and biomarker levels. The study aims to characterize the symptoms experienced during recovery and assess the impact of EA on inflammatory markers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with known peritoneal disease scheduled for Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.
Not a fit: Patients with severe comorbidities or those whose cancer treatment may interfere with the study's outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve symptom management and quality of life for patients recovering from complex cancer surgeries.
How similar studies have performed: While the use of electroacupuncture in symptom management is gaining interest, this specific application in the context of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Irvine, California and 1 other locations
- UCI Health Susan Samueli Integrative Health Institute — Irvine, California, United States (Not_yet_recruiting)
- University of California Irvine, Health — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Oliver Eng, MD — University of California, Irvine
- Study coordinator: Oliver Eng, MD
- Email: oeng@hs.uci.edu
- Phone: (714) 456-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.