Electroacupuncture for Symptom Management after Cytoreductive Surgery with or without Hyperthermic Intraperitoneal Chemotherapy

Status: active

This clinical trial tests the effect of electroacupuncture (EA) in treating symptoms such as pain, nausea/vomiting, diarrhea, and insomnia in cancer patients after undergoing surgery to remove as many tumor cells as possible (cytoreductive surgery [CRS]) with or without heated (hyperthermic) intraperitoneal chemotherapy (HIPEC). Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. It is a type of complementary and alternative medicine. EA is a procedure in which pulses of weak electrical current are sent through acupuncture needles into acupuncture points in the skin. Giving EA may improve treatment-related symptoms in cancer patients after undergoing CRS with or without HIPEC.

Inclusion Criteria

Patients with known peritoneal disease who are scheduled to undergo CRS +/- HIPEC
Age ≥ 18 years
Expected survival greater than 9 months
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

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

PRIMARY OBJECTIVE:

I. To examine the feasibility of utilizing an EA protocol in patients who have undergone CRS +/- HIPEC.

SECONDARY OBJECTIVES:

I. To characterize symptoms experienced by patients during recovery from CRS +/- HIPEC.

II. To evaluate the utilization of EA in symptom management during recovery from CRS +/- HIPEC.

EXPLORATORY OBJECTIVE:

I. To evaluate levels of biomarkers such as circulating brain-derived neurotrophic factor (BDNF), pro-inflammatory cytokines (interleukin [IL]-1beta, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor [TNF]-alpha), mitochondrial deoxyribonucleic acid (DNA) after CRS +/- HIPEC and with utilization of EA.

OUTLINE:

Patients undergo EA over 30 minutes-1 hour once weekly (QW) over 8-10 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.

After completion of study intervention, patients are followed up within 2 weeks.

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Electroacupuncture for Symptom Management after Cytoreductive Surgery with or without Hyperthermic Intraperitoneal Chemotherapy

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Electroacupuncture for Symptom Management after Cytoreductive Surgery with or without Hyperthermic Intraperitoneal Chemotherapy

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