The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy

The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study

This pilot study is designed to determine whether acupuncture is a feasible, effective and safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as compared with a wait-list control.

Study Overview

• Status: Completed
• Conditions: Chemotherapy; Breast Cancer Female; Insomnia, Secondary
• Intervention / Treatment: Device: Acupuncture

Detailed Description

Hypothesis:

Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a wait-list control.

Objective:

To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the wait-list control group.

Design and strategy:

This is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list control. All patients in the 2 groups will receive routine Western medical care for symptom management.

Study instrument:

Insomnia Severity Index (ISI) will be employed as a primary outcome assessment.

Intervention:

In the treatment group, 12 sessions acupuncture treatment (electroacupuncture & auricular acupressure) will be given twice a week for 6 weeks after randomization. In the wait-list control group, no treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as treatment group.

Main outcome measures:

Primary outcome: ISI scores will be measured at week 0, 3, 6, 10, 14.

Secondary outcomes:

Pittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer Therapy-Breast Cancer, and adverse events will be documented and compared between groups.

Data analysis: The primary endpoint will be the continuous ISI score. For the primary analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test on the average ISI score will be performed to access the significance of the treatment effects; otherwise, a nonparametric approach will be taken.

Expected outcome: ISI score of the acupuncture group is expected to be significantly lower than wait-list control group after 6 weeks of treatment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female patients between 18 and 75 years of age;
2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;
3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;
4. Insomnia onset after the diagnosis of breast cancer;
5. 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;
6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;
7. Expected survival time of more than 6 months;
8. Ability to understand the nature of the study and willingness to give informed consent;
9. Ability to provide responses during outcome measurement.

Exclusion Criteria:

1. Insomnia before the diagnosis of breast cancer;
2. Other sleep disorder (e.g., obstructive sleep apnoea);
3. Shift work or irregular sleep pattern;
4. Severe visual, hearing or language defects;
5. Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL);
6. With pacemakers or other electronic implants that could interfere with electroacupuncture;
7. History of acupuncture use in the previous 3 months;
8. Participation in other clinical trials with intervention within 3 months of the beginning of the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electroacupuncture (EA) and Auricular Acupuncture (AA); 12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.	Device: Acupuncture; Electroacupuncture (EA) and Auricular Acupuncture (AA)
NO_INTERVENTION: Wait-list control; No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Insomnia Severity Index (ISI)	week 0, 3, 6 (primary outcome), 10, 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Pittsburgh Sleep Quality Index	week 0, 3, 6, 10, 14
Sleep diary	week 0, 6
Actigraphy	week 0, 6
Functional Assessment of Cancer Therapy-Breast Cancer	week 0, 6, 10, 14
Adverse events	week 0 to week 6

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• Zhang J, Qin Z, So TH, Chen H, Lam WL, Yam LL, Yan Chan P, Lao L, Zhang ZJ. Electroacupuncture Plus Auricular Acupressure for Chemotherapy-Associated Insomnia in Breast Cancer Patients: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019103. doi: 10.1177/15347354211019103.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2019
• Primary Completion (ACTUAL): June 9, 2020
• Study Completion (ACTUAL): October 31, 2020

Study Registration Dates

• First Submitted: December 2, 2018
• First Submitted That Met QC Criteria: December 2, 2018
• First Posted (ACTUAL): December 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; Breast cancer; Insomnia; Chemotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Neoplasms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: UW 18-526

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No