Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy (BCI)

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: NCT04144309
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Zhang Zhang-Jin, The University of Hong Kong

Brief Summary:
The proposed study is a randomized, parallel-group, placebo-controlled, subject- and assessor-blind trial. It is designed according to CONSORT and STRICTA recommendations. The 138 subjects will be randomly assigned to one of the two arms using block randomization in a 1:1 ratio: (I) acupuncture treatment, and (II) sham treatment. In groups (I) and (II), acupuncture or sham acupuncture treatment will be given twice a week for 6 weeks (12 sessions). A maintenance tapering treatment schedule will then be applied once per month for 3 months (3 sessions). The primary outcome will be improvement in sleep quality as measured by the change of ISI after 6 weeks of treatment. Secondary outcome assessment tools will include PSQI, HADS, BPI, BFI, FACT-B, sleep diaries, drug diaries, blinding success questionnaire and reports of adverse events. The subjects will be scheduled for on-site follow-up assessments at 3 and 6 months after the last treatment. An intention to treat (ITT) approach will be used for data analysis.

Condition or disease Intervention/treatment Phase
Insomnia, Secondary Breast Cancer Female Chemotherapy Procedure: Electroacupuncture (EA) and Auricular Acupressure (AA) Procedure: Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA) Not Applicable

Detailed Description:

Insomnia is a frequent and disturbing symptom among cancer patients. Studies have found that cancer treatments, particularly chemotherapy, are a major cause of cancer-related insomnia. However, insomnia is under-treated in most breast cancer patients because effective, safe evidence-based treatments are lacking.

Acupuncture has been used for thousands of years to treat various diseases, including insomnia. Our previous research demonstrated the efficacy and safety of acupuncture as a treatment for insomnia. However, the effect of acupuncture on insomnia in breast cancer patients who undergo chemotherapy has been rarely studied. We propose this randomized controlled trial to examine the feasibility, effect and safety of acupuncture as a treatment for insomnia in breast cancer patients who undergo chemotherapy.

Hypothesis: We hypothesize that acupuncture is a feasible, effective and safe method for the alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a sham control.

Primary Aim: To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the sham control group, as measured by the ISI after 6 weeks of treatment.

Secondary Aims: 1) To determine whether other sleep-related parameters in the acupuncture group improve more than those of the control group, as measured at different time points by Actiwatch, sleep diary, Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI) and Brief Pain Inventory (BPI). 2) To assess by adverse event (AE) analysis whether acupuncture is safe for treatment of insomnia in breast cancer patients undergoing chemotherapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Sham-Controlled Trial
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: True acupuncture group
12 sessions of acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.
Procedure: Electroacupuncture (EA) and Auricular Acupressure (AA)

EA: Ten points will be used, including GV24 (Shenting), GV20 (Baihui), EX-HN1 (Sishenchong), PC6 (Neiguan), CV12 (Zhongwan), CV4 (Guanyuan), ST25 (Tianshu), ST36 (Zusanli), SP6 (Sanyinjiao), KI3 (Taixi).

AA: Vaccaria seeds will be embedded by acupuncturists on three auricular points (Shenmen, Sympathetic and Heart) and maintained between EA treatments.


Placebo Comparator: Sham acupuncture group
12 sessions of sham acupuncture treatment (SE+SA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.
Procedure: Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)

SE: The sham acupuncture treatment procedure, including the acupoint selection principle, sterilization procedure and treatment schedule, will be the same as in the acupuncture treatment group, except that sham points 1 to 2 cm exterior and inferior to the real points will be used, and no needle penetration or electric stimulation will be performed.

SA: Three sham auricular points in the helix region (HX7, HX8, HX9) will be selected. Instead of Vaccaria seeds, soft Junci Medulla (1 to 2 mm in length, dyed black) will be used to mimic real AA with no pressure.





Primary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week. ]
    The primary outcome will be the change of ISI score between the baseline and the end of the 6-week treatment. The ISI is a seven-item questionnaire devised to diagnose and assess the severity of insomnia.


Secondary Outcome Measures :
  1. Actiwatch [ Time Frame: Baseline, 6 week. ]
    The subjects will wear Actiwatch for 1 week at baseline period and the end of 6-week treatment.

  2. Sleep diary [ Time Frame: Baseline, 6 week. ]
    Subjects will be given daily sleep diary for 1 week at baseline period and the end of 6-week treatment.

  3. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week. ]
    The PSQI is a reliable and valid self-reported questionnaire that assesses sleep quality over 1 month.

  4. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week. ]
    The HADS, a 14-item self-rated questionnaire, evaluates the severity of depressive and anxiety symptoms.

  5. Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week. ]
    The BFI is a brief screening tool designed to assess the severity and impact of cancer-related fatigue on daily functioning.

  6. Brief Fatigue Inventory (BPI) [ Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week. ]
    The BPI is a self-administered questionnaire designed to assess cancer pain.

  7. Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) [ Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week. ]
    The FACT-B is a patient-reported outcome measure used to assess health-related quality of life in breast cancer patients.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients between 18 and 75 years of age.
  • Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer.
  • Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months.
  • Insomnia onset after the diagnosis of breast cancer.
  • Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks.
  • Expected survival time of more than 6 months.
  • Ability to understand the nature of the study and willingness to give informed consent.
  • Ability to provide responses during outcome measurement.

Exclusion Criteria:

  • Other sleep disorder (e.g., obstructive sleep apnoea).
  • Shift work or irregular sleep pattern.
  • Severe visual, hearing or language defects.
  • Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL).
  • History of acupuncture use in the previous 3 months.
  • Participation in other clinical trials with intervention within 3 months of the beginning of the trial.

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): NCT04144309


Contacts
Layout table for location contacts
Contact: Zhang-Jin ZHANG, MMed, PhD +852 3917 6445 zhangzj@hku.hk
Contact: Jia-Ling ZHANG, M.B., M.Med +852 9249 3025 zhangjl0@hku.hk

Locations
Layout table for location information
Hong Kong
Department of Clinical Oncology, Queen Mary Hospital Recruiting
Hong Kong, Hong Kong, 999077
Contact: Tsz-Him SO, MBBS, BCM    +852 2255 4352    sth495@hku.hk   
Principal Investigator: Tsz-Him SO, MBBS, BCM         
Hong Kong Sanatorium & Hospital Recruiting
Hong Kong, Hong Kong, 999077
Contact: Tien-Yee CHANG, MBBS, PDipID    +852 2255 7999    Amy.TY.Chang@hksh.com   
Principal Investigator: Tien-Yee CHANG, MBBS, PDipID         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Zhang-Jin ZHANG, MMed, PhD The University of Hong Kong
Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Prof. Zhang Zhang-Jin, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04144309    
Other Study ID Numbers: UW 19-045
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Zhang Zhang-Jin, The University of Hong Kong:
Acupuncture
Insomnia
Breast cancer
Chemotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders