Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperito… (NCT06340906) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
United States20 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Exp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited
Timeframe: Through study completion; approximately 1.5 years.
2
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Patient Recruitment Rate
Timeframe: Through study completion; approximately 1.5 years.
3
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Reasons for Abstaining from Participation
Timeframe: Through study completion; approximately 1.5 years.
4
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Recruitment Duration
Timeframe: Through study completion; approximately 1.5 years.
5
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Completed Electroacupuncture Sessions
Timeframe: Through study completion; approximately 1.5 years.
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Proportion of Completed Electroacupuncture Sessions
Timeframe: Through study completion; approximately 1.5 years.