Breast Cancer Female, Chemotherapy, Insomnia, Secondary
Conditions
Keywords
Acupuncture, Insomnia, Breast cancer, Chemotherapy
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.
Interventions
DEVICEAcupuncture
Electroacupuncture (EA) and Auricular Acupuncture (AA)
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Insomnia Severity Index (ISI) | week 0, 3, 6 (primary outcome), 10, 14 |
Secondary
| 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 |
Countries
Hong Kong
Outcome results
None listed