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Trial Title:
Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
NCT ID:
NCT06340906
Condition:
Cancer
Conditions: Official terms:
Hyperthermia
Fever
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a single-arm, prospective pilot/feasibility study.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Electroacupuncture
Description:
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.
Arm group label:
Treatment Arm
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.
Detailed description:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCI Health Susan Samueli Integrative Health Institute
Address:
City:
Irvine
Zip:
92697
Country:
United States
Contact:
Last name:
Matthew Heshmatipour, BSc
Email:
mheshmat@hs.uci.edu
Start date:
September 1, 2024
Completion date:
January 30, 2026
Lead sponsor:
Agency:
University of California, Irvine
Agency class:
Other
Source:
University of California, Irvine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06340906
