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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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 to improve 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).
* To compare the reduction of structural (brain gray matter) and functional connectivity at the prefrontal, medial temporal, and parietal brain regions pre- and post-EA treatment.
* To assess the safety and feasibility of administering EA to manage symptom clusters in cancer patients and survivors.
* As the UCI MINDS C2C registry (UCI IRB Approval #: HS# 2015-2494) will be leveraged to recruit some patients, we will quantify the characteristics associated with non-response to our study advertisement among C2C registrants using C2C-collected data.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized sham-controlled, patient and assessor-blinded pilot trial.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment Arm

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 Type EXPERIMENTAL

Electroacupuncture

Intervention Type OTHER

EA at 13 standardized acu-points that were chosen for their therapeutic effects: Shenting (GV24), Baihui (DU20), Sinshencong (EX-HN1), Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6) bilateral, Shenmen (HT7) bilateral, Zusanli (ST36) bilateral, Sanyinjiao (SP6) bilateral, Taixi (KI3) bilateral, Zhaohai (KI6) bilateral, Hegu (LI4) bilateral, Taichong (LIV3) bilateral

Control Arm

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.

Group Type SHAM_COMPARATOR

Sham-Electroacupuncture

Intervention Type OTHER

Non-disease related points with electrical stimulation: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Fuyang (BL59) bilateral, Kunlun (BL60) bilateral, Sanyangluo (TE8), Sidu (TE9) bilateral, Daheng (SP15) bilateral

Interventions

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Electroacupuncture

EA at 13 standardized acu-points that were chosen for their therapeutic effects: Shenting (GV24), Baihui (DU20), Sinshencong (EX-HN1), Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6) bilateral, Shenmen (HT7) bilateral, Zusanli (ST36) bilateral, Sanyinjiao (SP6) bilateral, Taixi (KI3) bilateral, Zhaohai (KI6) bilateral, Hegu (LI4) bilateral, Taichong (LIV3) bilateral

Intervention Type OTHER

Sham-Electroacupuncture

Non-disease related points with electrical stimulation: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Fuyang (BL59) bilateral, Kunlun (BL60) bilateral, Sanyangluo (TE8), Sidu (TE9) bilateral, Daheng (SP15) bilateral

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with cancer that have received anti-cancer treatment
* 16 years of age or older
* Life expectancy ≥ 6 months
* Complaints of one or more of the following symptoms: memory impairment/attention deficit, fatigue, insomnia, depression, or anxiety over the past 7 days

Exclusion Criteria

* Presence of metastasis
* Severe needle phobia
* Severe psychiatric or medical disorders which would affect cognitive assessments
* 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

\- Has any contraindications to fMRI including metal fragments/implants in the body, sever claustrophobia, and non-removable metal orthodontic braces, metallic retainers and oral wires.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No