Clinical trial NCT05283577: Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors
Official title: Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors (EAST): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized sham-controlled, patient and assessor-blinded pilot trial.
Primary purpose: SUPPORTIVE_CARE

Brief 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. An optional neuroimaging procedure will be available to all eligible participants. In total, study participation will last for 14 weeks.

Detailed description: 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.

Eligibility criteria: 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

Additional exclusion criteria for optional neuroimaging procedure:

- 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.

Primary outcomes:
measure: Subjective Cognitive Function (FACT-Cog version 3)
timeFrame: All the mean scores will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Secondary outcomes:
measure: Objective Cognitive Function (CANTAB®,)
timeFrame: All the mean scores will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
measure: Fatigue (MFSI-SF)
timeFrame: All the mean scores will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
measure: Psychological Distress and Insomnia (RSCL)
timeFrame: All the mean scores will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
measure: Quality of Life (EORTC QLQ-30)
timeFrame: All the mean scores will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
measure: Quality of Life (EQ-5D-5L)
timeFrame: All the mean scores will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
measure: Safety Monitoring
timeFrame: Through study completion, an average of 14 weeks per participant.
measure: Biomarkers - Plasma BDNF (pg/ml)
timeFrame: BDNF levels will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
measure: Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL)
timeFrame: Cytokine levels will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
measure: Biomarkers - Mitochondrial DNA content
timeFrame: mtDNA content will be compared before acupuncuture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
measure: Biomarkers - Gray matter volume
timeFrame: Neuroimaging measures will be compared before acupuncuture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
measure: Biomarkers - White matter volume
timeFrame: Neuroimaging measures will be compared before acupuncuture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
measure: Biomarkers - Mean diffusivity
timeFrame: Neuroimaging measures will be compared before acupuncuture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
measure: Biomarkers - Fractional anisotropy
timeFrame: Neuroimaging measures will be compared before acupuncuture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
measure: Biomarkers - Radial diffusivities
timeFrame: Neuroimaging measures will be compared before acupuncuture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
measure: Biomarkers - Axial diffusivities
timeFrame: Neuroimaging measures will be compared before acupuncuture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
measure: Biomarkers - Resting state functional connectivities
timeFrame: Neuroimaging measures will be compared before acupuncuture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
measure: Feasibility - Recruitment (number of participants recruited)
timeFrame: Through study completion, approximately 2 years.
measure: Feasibility - Recruitment (rate of recruitment)
timeFrame: Through study completion, approximately 2 years.
measure: Feasibility - Recruitment (reasons for declining participation)
timeFrame: Through study completion, approximately 2 years.
measure: Feasibility - Recruitment (time spent on recruitment)
timeFrame: Through study completion, approximately 2 years.
measure: Feasibility - Compliance (number of acupuncture sessions successfully completed)
timeFrame: Through study completion, approximately 2 years.
measure: Feasibility - Compliance (proportion of participants completing the scheduled acupuncture sessions)
timeFrame: Through study completion, approximately 2 years.
measure: Feasibility - Acceptability
timeFrame: Upon completion of treatment, at 10 weeks from baseline.
measure: Feasibility - Satisfaction
timeFrame: Upon completion of treatment, at 10 weeks from baseline.
measure: Feasibility - Blinding assessment
timeFrame: Upon completion of treatment, at 10 weeks from baseline.
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Health Susan Samueli Integrative Health Institute
state: California
Study officials:
affiliation: UCI
name: Alexandre Chan, PharmD
role: PRINCIPAL_INVESTIGATOR
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