Status:
COMPLETED
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
Lead Sponsor:
The University of Hong Kong
Conditions:
Insomnia, Secondary
Breast Cancer Female
Eligibility:
FEMALE
18-75 years
Phase:
NA
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 ...
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. Objectiv...
Eligibility Criteria
Inclusion
- 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
- Insomnia before the diagnosis of breast cancer;
- 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);
- With pacemakers or other electronic implants that could interfere with electroacupuncture;
- 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.
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03762694
Start Date
March 26 2019
End Date
October 31 2020
Last Update
April 26 2022
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong