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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762694
• Other study ID #: UW 18-526
• Status: Completed
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: April 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Chemotherapy
• Insomnia, Secondary
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Acupuncture
Electroacupuncture (EA) and Auricular Acupuncture (AA)

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index (ISI)		week 0, 3, 6 (primary outcome), 10, 14
Secondary	Pittsburgh Sleep Quality Index		week 0, 3, 6, 10, 14
Secondary	Sleep diary		week 0, 6
Secondary	Actigraphy		week 0, 6
Secondary	Functional Assessment of Cancer Therapy-Breast Cancer		week 0, 6, 10, 14
Secondary	Adverse events		week 0 to week 6