Abstract
Background: Studies suggest that chemotherapy is one of the major causes of insomnia in cancer patients. Acupuncture is widely used for insomnia. This study aims to examine whether acupuncture is effective, safe and feasible for alleviating insomnia in breast cancer patients undergoing chemotherapy.
Methods: We plan to conduct a randomized, wait‐list controlled, assessor‐blinded clinical trial. Thirty patients with nonmetastatic breast cancer, who have insomnia onset after chemotherapy, will be randomly allocated to either acupuncture group or wait‐list control group at a 1:1 ratio. The acupuncture group will receive acupuncture twice a week for 6 weeks in addition to routine care. The wait‐list control group will receive routine care only. They will receive 12 sessions acupuncture after the waiting period. The primary outcome measurement will be Insomnia Severity Index. The secondary outcomes include Pittsburgh Sleep Quality Index, sleep diary, actiwatch, Functional Assessment of Cancer Therapy‐Breast Cancer, and adverse events. Follow‐up assessment will be performed at week 9 and 12.
Discussion: This clinical trial will expand our knowledge about the effect, safety and feasibility of acupuncture for insomnia in breast cancer patients undergoing chemotherapy. The study findings will provide useful information for designing a larger clinical trial. Ethics: This study protocol has been approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (No. UW 18‐526). Trial Registration: This trial is registered with ClinicalTrials.gov (ID: NCT03762694).
Methods: We plan to conduct a randomized, wait‐list controlled, assessor‐blinded clinical trial. Thirty patients with nonmetastatic breast cancer, who have insomnia onset after chemotherapy, will be randomly allocated to either acupuncture group or wait‐list control group at a 1:1 ratio. The acupuncture group will receive acupuncture twice a week for 6 weeks in addition to routine care. The wait‐list control group will receive routine care only. They will receive 12 sessions acupuncture after the waiting period. The primary outcome measurement will be Insomnia Severity Index. The secondary outcomes include Pittsburgh Sleep Quality Index, sleep diary, actiwatch, Functional Assessment of Cancer Therapy‐Breast Cancer, and adverse events. Follow‐up assessment will be performed at week 9 and 12.
Discussion: This clinical trial will expand our knowledge about the effect, safety and feasibility of acupuncture for insomnia in breast cancer patients undergoing chemotherapy. The study findings will provide useful information for designing a larger clinical trial. Ethics: This study protocol has been approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (No. UW 18‐526). Trial Registration: This trial is registered with ClinicalTrials.gov (ID: NCT03762694).
| Original language | English |
|---|---|
| Pages (from-to) | A3 |
| Number of pages | 1 |
| Journal | Journal of Alternative and Complementary Medicine |
| Volume | 25 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 1 Oct 2019 |
| Event | SAR 2019: Acupuncture Research, Health Care Policy & Community Health. Closing the Loop - Burlington, United States Duration: 27 Jun 2019 → 29 Jun 2019 https://www.liebertpub.com/doi/10.1089/acm.2019.29074.abstracts (Conference abstracts) |
