ACTIVE_NOT_RECRUITING

Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. An optional neuroimaging procedure will be available to all eligible participants. 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

Quick Facts

Study Start:2022-04-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05283577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients diagnosed with cancer that have received anti-cancer treatment
  2. * 16 years of age or older
  3. * Life expectancy ≥ 6 months
  4. * Complaints of one or more of the following symptoms: memory impairment/attention deficit, fatigue, insomnia, depression, or anxiety over the past 7 days
  1. * Presence of metastasis
  2. * Severe needle phobia
  3. * Severe psychiatric or medical disorders which would affect cognitive assessments
  4. * Known bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)
  5. * Has pacemaker or other electronic metal implants
  6. * Epilepsy
  7. * Already receiving acupuncture therapy or received acupuncture treatment in the past 3 months.
  8. * Breastfeeding, pregnant or are planning get pregnant during the study period

Contacts and Locations

Principal Investigator

Alexandre Chan, PharmD
PRINCIPAL_INVESTIGATOR
UCI

Study Locations (Sites)

UCI Health Susan Samueli Integrative Health Institute
Irvine, California, 92697
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Alexandre Chan, PharmD, PRINCIPAL_INVESTIGATOR, UCI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-04-15
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer