Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
NCT ID: NCT06340906
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-01
2026-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of California, Irvine
OTHER
Responsible Party
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Oliver Eng
Associate Professor
Principal Investigators
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Oliver Eng, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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UCI Health Susan Samueli Integrative Health Institute
Irvine, California, United States
University of California Irvine, Health
Orange, California, United States
Countries
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Central Contacts
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Facility Contacts
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Matthew Heshmatipour, BSc
Role: primary
Oliver Eng, MD
Role: primary
References
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Osann K, Wilford J, Wenzel L, Hsieh S, Tucker JA, Wahi A, Monk BJ, Nelson EL. Relationship between social support, quality of life, and Th2 cytokines in a biobehavioral cancer survivorship trial. Support Care Cancer. 2019 Sep;27(9):3301-3310. doi: 10.1007/s00520-018-4617-z. Epub 2019 Jan 5.
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Quenet F, Elias D, Roca L, et al: A UNICANCER phase III trial of hyperthermic intra-peritoneal chemotherapy (HIPEC) for colorectal peritoneal carcinomatosis (PC): PRODIGE 7. [Internet]. J Clin Oncol 36:LBA3503-LBA3503, 2018Available from: https://doi.org/10.1200/JCO.2018.36.18_suppl.LBA3503
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Yan TD, Deraco M, Baratti D, Kusamura S, Elias D, Glehen O, Gilly FN, Levine EA, Shen P, Mohamed F, Moran BJ, Morris DL, Chua TC, Piso P, Sugarbaker PH. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol. 2009 Dec 20;27(36):6237-42. doi: 10.1200/JCO.2009.23.9640. Epub 2009 Nov 16.
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Other Identifiers
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UCI 23-29
Identifier Type: OTHER
Identifier Source: secondary_id
4573
Identifier Type: -
Identifier Source: org_study_id