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

NCT ID: NCT03762694

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-26
• Study Completion Date: 2020-10-31

Brief Summary

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.

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.

Conditions

Insomnia, Secondary; Breast Cancer Female; Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Electroacupuncture (EA) and Auricular Acupuncture (AA)

12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

Electroacupuncture (EA) and Auricular Acupuncture (AA)

Wait-list control

No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

Electroacupuncture (EA) and Auricular Acupuncture (AA)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor LAO Lixing

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 34036813 (View on PubMed)

Other Identifiers

UW 18-526

Identifier Type: -

Identifier Source: org_study_id