Through a scientific and standardized multicenter, randomized, and controlled study method, the investigators evaluated the clinical efficacy and safety of acupuncture in the treatment of breast cancer-related insomnia, with a view to providing a reliable theoretical basis for the treatment of breast cancer-related insomnia with acupuncture.
Insomnia associated with breast cancer is one of the most common symptoms among breast cancer patients, which seriously affects the life quality of breast cancer patients. Therefore, how to better improve their life quality and insomnia symptoms is of important clinical significance. Previous studies have shown that acupuncture may be beneficial for improving sleep disorders in cancer patients. However, the available clinical evidence is mixed, and clinical studies on acupuncture for breast cancer-associated insomnia lack well-designed, high-quality clinical evidence. The purpose of this study was to evaluate the clinical efficacy and safety of acupuncture for breast cancer-associated insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
264
All acupuncture locations will be sterilized on a routine basis. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate de qi, a sensation generally associated with acupuncture, including swelling, soreness, numbness, and heaviness.
The placebo needles selected for this study are flat-tipped needles without a tip that cannot be pierced into the skin. Also, an external patch device will hold the needles in place and these needles are visually pierced into the skin. At the end of the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball to allow the patient to feel the "needles" being pulled out.
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Treatment response rate of Insomnia Severity Index (ISI)
The percentage of people whose total Insomnia Severity Index (ISI) score decreased by ≥8 points at the end of week 4 treatment compared to the baseline score. The ISI consists of 7 items to assess the nature and symptoms of the subject's sleep disorders. Questions addressed subjects' subjective ratings of sleep quality, including the severity of symptoms, subjects' satisfaction with their sleep patterns, the impact of the degree of insomnia on daily functioning, subjects' awareness of the impact of insomnia on themselves, and their level of frustration due to their sleep disorders. The scores were 0 to 4, with a total score range from 0 to 28. Higher scores indicate more severe insomnia. ISI levels can be classified as no clinically significant insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21), and severe insomnia (22 to 28).
Time frame: Week 4 (end of treatment)
Treatment remission rate of Insomnia Severity Index (ISI)
The percentage of people with a total score of \<8 points in total Insomnia Severity Index (ISI) score at the end of week 4, 8 and 16 of treatment compared to the baseline score. The ISI consists of 7 items to assess the nature and symptoms of the subject's sleep disorders. Questions addressed subjects' subjective ratings of sleep quality, including the severity of symptoms, subjects' satisfaction with their sleep patterns, the impact of the degree of insomnia on daily functioning, subjects' awareness of the impact of insomnia on themselves, and their level of frustration due to their sleep disorders. The scores were 0 to 4, with a total score range from 0 to 28. Higher scores indicate more severe insomnia. ISI levels can be classified as no clinically significant insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21), and severe insomnia (22 to 28).
Time frame: Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)
Sleep Efficiency (SE) with Sleep Diary
It will be determined by sleep diary subjectively. Sleep Efficiency(SE) is the percentage of time spent asleep while in bed. It is calculated by (TST / TIB) × 100%. Sleep parameters measured by sleep diary include Sleep Onset Latency (SOL),Wake After Sleep Onset(WASO),Early morning awakening(EMA), and Total Time in Bed (TIB). Total Sleep Time (TST) is calculated by subtracting SOL, WASO and EMA from TIB.
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Time frame: At baseline, weeks 1, 2, 3, and 4 (end of treatment)
Generalized Anxiety Disorder Scale (GAD-7)
It is a concise anxiety self-assessment instrument consisting of 7 items to assess patients' anxiety over the past two weeks. This questionnaire has a score of 0-3 for each entry and a total score of 21. The scores are 5-9 for mild anxiety, 10-14 for moderate anxiety, and 15-21 for severe anxiety.
Time frame: At baseline and week 4 (end of treatment)
Patient Health Questionnaire-9 (PHQ-9)
It is a simple and validated 9-item depression self-assessment tool that assesses patients' depression over the past 2 weeks. Each item is scored 0-3, with a total score of 27. Among them, 5-9 are mild depression, 10-14 are moderate depression, 15-19 are severe depression, and 20-27 are very severe depression.
Time frame: At baseline and week 4 (end of treatment)
Quality of Life Core Scale (QLQ-C30)
It contains 30 entries with six dimensions. Widely used in clinical studies, it is currently used to assess the quality of life situation of patients.
Time frame: At baseline and week 4 (end of treatment)
Sleep Efficiency (SE) with Actigraphy
The actigraphy device (wGT3X-BT. LLC, Pensacola, USA) can monitor sleep quality objectively. Sleep Efficiency(SE) is the percentage of time spent asleep while in bed. It is calculated by (TST / TIB) × 100%. The actigraphy device record Sleep Onset Latency (SOL),Wake After Sleep Onset(WASO), Early morning awakening(EMA), and Total Time in Bed (TIB). Total Sleep Time (TST) is calculated by subtracting SOL, WASO and EMA from TIB.
Time frame: At baseline, weeks 1 and 4 (end of treatment)
Weekly usage of remedial drugs
The percentage of participants who used emergency drugs.
Time frame: At weeks 1, 2, 3, and 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)
Incidence of adverse events
The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment.
Time frame: During 1-4 weeks
Treatment response rate of Insomnia Severity Index (ISI) at follow-up visits
The percentage of people whose total Insomnia Severity Index (ISI) score decreased by ≥8 points at the end of week 8 and 16 of the treatment compared to the baseline score. The ISI consists of 7 items to assess the nature and symptoms of the subject's sleep disorders. Questions addressed subjects' subjective ratings of sleep quality, including the severity of symptoms, subjects' satisfaction with their sleep patterns, the impact of the degree of insomnia on daily functioning, subjects' awareness of the impact of insomnia on themselves, and their level of frustration due to their sleep disorders. The scores were 0 to 4, with a total score range from 0 to 28. Higher scores indicate more severe insomnia. ISI levels can be classified as no clinically significant insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21), and severe insomnia (22 to 28).
Time frame: Week 8 (follow-up), and week 16(follow-up)
The mean changes of Insomnia Severity Index (ISI) from baseline
The ISI consists of 7 items to assess the nature and symptoms of the subject's sleep disorders. Questions addressed subjects' subjective ratings of sleep quality, including the severity of symptoms, subjects' satisfaction with their sleep patterns, the impact of the degree of insomnia on daily functioning, subjects' awareness of the impact of insomnia on themselves, and their level of frustration due to their sleep disorders. The scores were 0 to 4, with a total score range from 0 to 28. Higher scores indicate more severe insomnia. ISI levels can be classified as no clinically significant insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21), and severe insomnia (22 to 28).
Time frame: Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)
Sleep Awakening (SA) with Actigraphy
It is the number of sleep awakenings during the night that recorded with actigraphy device (wGT3X-BT. LLC, Pensacola, USA).
Time frame: At baseline, weeks 1 and 4 (end of treatment)
Average Awaken Time (AA) with Actigraphy
It is estimated by (Wake After Sleep Onset(WASO) / Sleep Awakening(SA)) measured in minutes that recorded with actigraphy device (wGT3X-BT. LLC, Pensacola, USA).
Time frame: At baseline, weeks 1 and 4 (end of treatment)