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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283577
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Alexandre Chan, University of California, Irvine

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.


Condition or disease Intervention/treatment Phase
Cancer Other: Electroacupuncture Other: Sham-Electroacupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized sham-controlled, patient and assessor-blinded pilot trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors (EAST): A Feasibility Study
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: 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.
Other: 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

Sham Comparator: 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.
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




Primary Outcome Measures :
  1. Subjective Cognitive Function (FACT-Cog version 3) [ Time Frame: 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. ]
    All subjects will complete the FACT-Cog version 3 questionnaire to assess self-perceived subjective cognitive function. FACT-Cog is a validated questionnaire containing 33 items in the domains of concentration, functional interference, mental acuity, memory, multitasking and verbal fluency. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning.


Secondary Outcome Measures :
  1. Objective Cognitive Function (CANTAB®,) [ Time Frame: 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. ]
    All subjects will complete Cambridge Neuropsychological Test Automated Battery (CANTAB®), to assess objective cognitive functions. CANTAB® is a computerized cognitive testing software to assess various cognitive domains. Both subjective and objective assessments are recommended by the International Cognition and Cancer Task Force (ICCTF).

  2. Fatigue (MFSI-SF) [ Time Frame: 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. ]
    Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) is a validated questionnaire that comprises of 30 items and contains 5 subscales, each with 6 items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. The total score is obtained by subtracting the vigour subscale from the sum of all the dimensions (total score range from 24 to 96), with a higher score indicating higher fatigue level.

  3. Psychological Distress and Insomnia (RSCL) [ Time Frame: 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. ]
    The Rotterdam Symptom Checklist (RSCL) will be used to measure the psychological symptoms (anxiety and depression) and insomnia. Psychological distress is indicated by a score of >16 in the psychological domain (range 7 to 28). Insomnia is measured by a single item in the checklist (not at all, a little, quite a bit, very much).

  4. Quality of Life (EORTC QLQ-30) [ Time Frame: 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. ]
    The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30) is a validated questionnaire developed to assess cancer patients' health-related quality of life. It incorporates 5 functional scales (cognitive, emotional, physical, role, and social), symptom scales (e.g. pain, fatigue, insomnia), and a global health scale. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale. Higher scores represent a better global health status and better degree of functioning while lower symptom scores indicate less severe symptoms.

  5. Quality of Life (EQ-5D-5L) [ Time Frame: 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. ]
    EQ-5D comprises a visual analog scale of general health status ranging from 0 (worst imaginable) to 100 (best imaginable) and a descriptive system based on five dimensions of health status: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D descriptive index responses were mapped into a single dimension health utility index (UI) ranging from death (0) to full health (1), with health states worse than death being possible (<0), by using utility weights for the US population.

  6. Safety Monitoring [ Time Frame: Through study completion, an average of 14 weeks per participant. ]
    Participants will be monitored for adverse events such as bruising, pain or discomfort, bleeding and possible infections. Severity are graded according to the Common Terminology Criteria for Adverse Events V5.

  7. Biomarkers - Plasma BDNF (pg/ml) [ Time Frame: 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. ]
    Plasma brain-derived neurotropic factor (BDNF) levels at each time point, and changes from baseline

  8. Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL) [ Time Frame: 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. ]
    Plasma cytokine levels at each time point, and changes from baseline

  9. Biomarkers - Mitochondrial DNA content [ Time Frame: 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. ]
    Mitochondrial DNA (mtDNA) content at each time point, and changes from baseline

  10. Biomarkers - Gray matter volume [ Time Frame: 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. ]
    Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)

  11. Biomarkers - White matter volume [ Time Frame: 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. ]
    Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)

  12. Biomarkers - Mean diffusivity [ Time Frame: 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. ]
    Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)

  13. Biomarkers - Fractional anisotropy [ Time Frame: 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. ]
    Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)

  14. Biomarkers - Radial diffusivities [ Time Frame: 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. ]
    Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)

  15. Biomarkers - Axial diffusivities [ Time Frame: 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. ]
    Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)

  16. Biomarkers - Resting state functional connectivities [ Time Frame: 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. ]
    Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)

  17. Feasibility - Recruitment (number of participants recruited) [ Time Frame: Through study completion, approximately 2 years. ]
    The number of participants recruited (% of target recruitment)

  18. Feasibility - Recruitment (rate of recruitment) [ Time Frame: Through study completion, approximately 2 years. ]
    Number of patients recruited per month

  19. Feasibility - Recruitment (reasons for declining participation) [ Time Frame: Through study completion, approximately 2 years. ]
    Reasons for declining participation will be documented.

  20. Feasibility - Recruitment (time spent on recruitment) [ Time Frame: Through study completion, approximately 2 years. ]
    Time spent on recruitment, in minutes, wil be documented to assess recruitment productivity.

  21. Feasibility - Compliance (number of acupuncture sessions successfully completed) [ Time Frame: Through study completion, approximately 2 years. ]
    Number of acupuncture sessions successfully completed in total

  22. Feasibility - Compliance (proportion of participants completing the scheduled acupuncture sessions) [ Time Frame: Through study completion, approximately 2 years. ]
    Proportion of participants completing all the scheduled acupuncture sessions

  23. Feasibility - Acceptability [ Time Frame: Upon completion of treatment, at 10 weeks from baseline. ]
    Study participants will complete a questionnaire evaluating their perceptions towards the EA treatment at the end of treatment.

  24. Feasibility - Satisfaction [ Time Frame: Upon completion of treatment, at 10 weeks from baseline. ]
    Participants will be asked if they are satisfied and benefited from the treatment, and whether they would consider undergoing treatment again outside of a trial setting.

  25. Feasibility - Blinding assessment [ Time Frame: Upon completion of treatment, at 10 weeks from baseline. ]
    Participants will be asked whether they believe that they have received EA or sham-EA at the end of treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283577


Contacts
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Contact: Alexandre Chan, PharmD 1-949-824-8896 a.chan@uci.edu
Contact: Ding Quan Ng 1-949-350-0096 dqng@uci.edu

Locations
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United States, California
UCI Health Susan Samueli Integrative Health Institute Recruiting
Irvine, California, United States, 92697
Contact: Matthew Heshmatipour, BSc (Biology)    1-949-462-4610    mheshmat@hs.uci.edu   
Contact: Ding Quan Ng, BSc (Pharm)(Hons)    1-949-350-0096    dqng@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Alexandre Chan, PharmD UCI
  Study Documents (Full-Text)

Documents provided by Alexandre Chan, University of California, Irvine:
Publications:

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Responsible Party: Alexandre Chan, Founding Chair and Professor of Clinical Pharmacy, University of California, Irvine
ClinicalTrials.gov Identifier: NCT05283577    
Other Study ID Numbers: HS#: 2021-6732
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes