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Electroacupuncture for Cancer-related Symptoms (EAST Trial)
N/A
Recruiting
Led By Alexandre Chan, PharmD
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
16 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 2 years.
Awards & highlights
EAST Trial Summary
This trial is being done to see if EA is a feasible intervention for symptom clusters in cancer patients and survivors, and to see if it could potentially reduce symptom clusters. There will be two groups of participants, those receiving EA and those receiving sham-EA, with both groups being followed for 14 weeks. At various timepoints throughout the study, participants will complete questionnaires and a cognitive test, and have blood drawn for biomarker analysis.
Who is the study for?
This trial is for cancer patients and survivors, aged 16 or older, who have a life expectancy of at least 6 months and are experiencing symptoms like memory issues, fatigue, insomnia, depression or anxiety. They must not be pregnant, breastfeeding or planning to become pregnant during the study. People with metastasis, severe needle phobia, major psychiatric conditions affecting cognition, bleeding disorders or epilepsy cannot join.Check my eligibility
What is being tested?
The trial tests Electroacupuncture (EA) against Sham-Electroacupuncture to manage symptom clusters in cancer patients/survivors over a 10-week period with weekly sessions. It also examines EA's effects on biomarkers related to these symptoms through blood tests and questionnaires assessing cognitive function and quality of life.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, common side effects from acupuncture can include soreness where the needles puncture the skin, minor bleeding or bruising at the needle sites.
EAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 16 years old or older.
EAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjective Cognitive Function (FACT-Cog version 3)
Secondary outcome measures
Biomarkers - Axial diffusivities
Biomarkers - Fractional anisotropy
Biomarkers - Gray matter volume
+22 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%
DRY VAGINA
4%
ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY
4%
TENSION / INNER UNREST
4%
RASH
4%
FAILING MEMORY
4%
SLEEPINESS / SEDATION
4%
DIARRHEA
4%
PRURITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Electroacupuncture (EA)
Sham Acupuncture (SA)
EAST Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Each participant will attend a total of 10 treatment visits (one visit per week), over the course of 10 weeks. Each EA session will be approximately 1 hour. Participants in the treatment arm will receive EA at 13 standardized acu-points that were chosen for their therapeutic effects.
Group II: Control ArmPlacebo Group1 Intervention
Each participant in the control arm will attend a total of 10 treatment visits (one visit per week), over the course of 10 weeks. Participants in the control arm will receive electrical stimulation at non-disease related acu-points for approximately 1 hour per session.
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
543 Previous Clinical Trials
1,922,913 Total Patients Enrolled
Alexandre Chan, PharmDPrincipal InvestigatorUCI
2 Previous Clinical Trials
306 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving or have received acupuncture in the last 3 months.I have experienced symptoms like memory issues, fatigue, insomnia, depression, or anxiety in the last week.I have cancer and have received treatment for it.I am 16 years old or older.I have a known bleeding disorder.I do not have severe mental or medical conditions that would affect thinking tests.My cancer has spread to other parts of my body.I have epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Control Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it still possible for individuals to enroll in this trial?
"Affirmative. Per the clinicaltrials.gov database, this clinical trial has been actively seeking participants since April 15th 2022 and was last revised on November 30th 2022. Overall, 64 patients are required to be enrolled from 2 different locations."
Answered by AI
How many volunteers have signed up for this research project?
"Yes, the clinicaltrials.gov website indicates that this experiment is currently accepting participants. It was initially published on April 15th 2022 and has since been updated to November 30th 2022. The study requires 64 subjects across 2 medical facilities."
Answered by AI
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