Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer - Female
- Chemotherapy
- Insomnia, Secondary
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Only males
Description
Insomnia is a frequent and disturbing symptom among cancer patients. Studies have found that cancer treatments, particularly chemotherapy, are a major cause of cancer-related insomnia. However, insomnia is under-treated in most breast cancer patients because effective, safe evidence-based treatments...
Insomnia is a frequent and disturbing symptom among cancer patients. Studies have found that cancer treatments, particularly chemotherapy, are a major cause of cancer-related insomnia. However, insomnia is under-treated in most breast cancer patients because effective, safe evidence-based treatments are lacking. Acupuncture has been used for thousands of years to treat various diseases, including insomnia. Our previous research demonstrated the efficacy and safety of acupuncture as a treatment for insomnia. However, the effect of acupuncture on insomnia in breast cancer patients who undergo chemotherapy has been rarely studied. We propose this randomized controlled trial to examine the feasibility, effect and safety of acupuncture as a treatment for insomnia in breast cancer patients who undergo chemotherapy. Hypothesis: We hypothesize that acupuncture is a feasible, effective and safe method for the alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a sham control. Primary Aim: To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the sham control group, as measured by the ISI after 6 weeks of treatment. Secondary Aims: 1) To determine whether other sleep-related parameters in the acupuncture group improve more than those of the control group, as measured at different time points by Actiwatch, sleep diary, Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI) and Brief Pain Inventory (BPI). 2) To assess by adverse event (AE) analysis whether acupuncture is safe for treatment of insomnia in breast cancer patients undergoing chemotherapy.
Tracking Information
- NCT #
- NCT04144309
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Zhang-Jin ZHANG, MMed, PhD The University of Hong Kong