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Behavioural Intervention
Treatment Arm for Cancer
N/A
Waitlist Available
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; approximately 1.5 years
Awards & highlights
Study Summary
This trial aims to see if using electroacupuncture can help manage symptoms like pain, nausea, diarrhea, and insomnia in patients who have had a specific type of surgery and chemotherapy. The study will also
Who is the study for?
This trial is for patients who've had Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy to treat cancer. It's designed to see if electroacupuncture can help manage symptoms like pain, nausea, vomiting, diarrhea, and insomnia post-surgery.Check my eligibility
What is being tested?
The study tests the use of electroacupuncture as a treatment for managing symptoms after specific cancer surgeries. The goal is to assess how well it works (effectiveness), how safe it is (safety), and whether patients are willing to stick with it (compliance).See study design
What are the potential side effects?
While not explicitly stated in the provided information, common side effects of electroacupuncture may include slight bleeding or bruising at needle sites, dizziness or fainting. Serious side effects are rare.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; approximately 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; approximately 1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Completed Electroacupuncture Sessions
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited
Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Patient Recruitment Rate
+3 moreSecondary outcome measures
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3
Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30
+1 moreOther outcome measures
Biomarkers - Plasma (pg/mL)
Biomarkers - Plasma BDNF (pg/ml)
Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL)
+9 moreSide effects data
From 2007 Phase 2 trial • 57 Patients • NCT0007111032%
INCREASED DREAM ACTIVITY
29%
HEADACHE
25%
REDUCED DURATION OF SLEEP:
25%
NAUSEA / VOMITING
25%
ORGASMIC DYSFUNCTION
11%
DIMINISHED SEXUAL DESIRE
11%
INCREASED DURATION OF SLEEP:
11%
INCREASED TENDENCY TO SWEATING
11%
ORTHOSTATIC DIZZINESS
7%
PHOTOSENSITIVITY
7%
EMOTIONAL INDIFFERENCE
7%
PALPITATIONS / TACHYCARDIA
4%
RASH
4%
DRY VAGINA
4%
SLEEPINESS / SEDATION
4%
ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY
4%
FAILING MEMORY
4%
TENSION / INNER UNREST
4%
DIARRHEA
4%
PRURITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Electroacupuncture (EA)
Sham Acupuncture (SA)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,923,023 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for patients to participate in this trial?
"Information from clinicaltrials.gov indicates that the current trial is not actively seeking participants. Despite being posted on 5/15/2024 and last updated on 3/25/2024, there are no ongoing recruitment efforts for this study. Nevertheless, it's important to note that out of a pool of active trials, there are currently 626 others open for patient enrollment."
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