Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Costa Mesa, California
Dates
study started
estimated completion
Principal Investigator
by Alexandre Chan

Description

Summary

This is a sham-controlled, patient and assessor-blinded pilot trial to evaluate the feasibility of administering EA as an intervention for symptom clusters in cancer patients and survivors, and to evaluate the degree that EA could reduce symptom clusters and the possible underlying mechanisms through examining its influence on biomarkers that are linked with the symptoms. Participants will be randomized to either the treatment arm (those who will receive EA) or the control arm (those who will receive sham-EA). The treatment period for both groups will be 10 weeks. There will be one study visit a week over the course of the 10-week treatment period, for a total of 10 study treatment visits. Participants in the treatment arm will receive EA at 13 standardized acu-points that have been chosen for their therapeutic effects. Participants in the control arm will receive electrical stimulation at non-disease acu-points. There will be four data collection time points for each participant: (1) baseline, (2) mid-treatment (5 weeks from baseline), (3) end of treatment (10 weeks from baseline), and (4) 4 weeks after end of treatment (14 weeks from baseline). At each of these timepoints, 10mL of peripheral blood will be collected for a biomarker analysis and participants will be asked to complete 4 questionnaires and a computerized cognitive test to evaluate their cognitive function, fatigue level, insomnia, psychological distress, and quality of life. In total, study participation will last for 14 weeks.

Official Title

Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors (EAST): A Feasibility Study

Details

The purpose of this study is to investigate the efficacy, safety, and feasibility of offering electroacupuncture as an intervention to improve cancer-related symptoms (cognitive impairment, fatigue, psychological distress and insomnia) and quality of life among cancer patients and survivors receiving care at UCI Health. In addition, changes in biomarkers (plasma BDNF, pro-inflammatory cytokines and mitochondrial DNA) known to be associated with cancer-related symptoms. We hypothesize that EA is an effective, safe, and feasible intervention for cancer patients and survivors. Our specific aims are as follows: To compare the efficacy of EA versus sham-EA control in reducing cognitive toxicity, fatigue, psychological distress, insomnia and quality of life. To evaluate the impact of EA versus sham-EA control on biomarkers, including circulating BDNF, pro-inflammatory cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha), mitochondrial DNA (oxidative stress indicator), and safety. To assess the feasibility of administering EA to manage symptom clusters in cancer patients.

Keywords

Cancer Syndrome Electroacupuncture

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients diagnosed with cancer that have received anti-cancer treatment within the past one year
  • ≥ 18 years of age
  • Life expectancy ≥ 6 months
  • Complaints of two or more of the following symptoms (fulfilling the definition of a symptom cluster): memory impairment/attention deficit, fatigue, insomnia, depression, or anxiety over the past 7 days
  • Able to provide informed consent to participate in the study.

You CAN'T join if...

  • Presence of metastasis
  • Severe needle phobia
  • Psychiatric or medical disorders which would affect cognitive assessments, such as, dementia, Alzheimer's disease, a history of any neurological condition, traumatic brain injury, stroke, and the use of psychotropic medication
  • Known bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)
  • Has pacemaker or other electronic metal implants
  • Epilepsy
  • Already receiving acupuncture therapy or received acupuncture treatment in the past 3 months.
  • Breastfeeding, pregnant or are planning get pregnant during the study period

Location

  • UCI Health Susan Samueli Integrative Health Institute accepting new patients
    Costa Mesa California 92626 United States

Lead Scientist at UC Irvine

  • Alexandre Chan
    Clinical Professor, Clinical Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences. Authored (or co-authored) 65 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05283577
Study Type
Interventional
Participants
Expecting 64 study participants
Last Updated