Acupuncture therapy of “regulating spirit and soothing liver” for treating insomnia in patients with breast cancer
| ISRCTN | ISRCTN12913513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12913513 |
| Secondary identifying numbers | 2022-4-2234 |
- Submission date
- 04/01/2023
- Registration date
- 07/03/2023
- Last edited
- 13/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Cancer patients often suffer from insomnia, which is a risk factor for cancer progression, and the influence of insomnia on different cancer varies. It is imperative to pay attention to and treat insomnia in patients with different types of cancer. Breast cancer patients have a high incidence of insomnia, which is often accompanied by anxiety, depression, and fatigue. These symptoms fit the pathogenesis of "liver depression" and "weakened body resistance" in traditional Chinese medicine theory. Based on the effective treatment of common insomnia with acupuncture, it is feasible to explore the efficacy and safety of acupuncture treatment of insomnia in patients with breast cancer. Dr De’an Zhou, a National Celebrated Traditional Chinese Medicine Expert, invented the acupuncture therapy of “regulating spirit”, which can effectively improve insomnia. On this basis, and in consideration of the pathogenesis of “liver depression” and “a deficiency of Qi [low energy] and blood” in breast cancer, the research team proposed the acupuncture therapy of “regulating spirit and soothing liver”, which focuses on four acupoints from the liver meridian, gallbladder meridian, spleen meridian and stomach meridian in the therapy of “regulating spirit”. The new therapy can regulate the “spirit of mind and brain” and “the Qi of the liver and spleen”, and will treat insomnia in patients with breast cancer effectively. The purpose of this study is to evaluate the effects and safety of the acupuncture therapy of “regulating spirit and soothing liver” on insomnia in patients with breast cancer.
Who can participate?
Breast cancer patients with insomnia
What does the study involve?
Participants recruited into this study will be randomly divided into 2 groups according to a 1:1 ratio. Group A will receive normal acupuncture therapy and Group B will receive shallow acupuncture therapy as a control group. The treatment of both groups will be conducted over a period of 4 weeks, at a frequency of 3 sessions per week. The therapeutic effect is graded using a sleep scale.
What are the possible benefits and risks of participating?
Patients who participate in this trial will receive professional sleep assessment, corrective sleep concepts and acupuncture therapy for free, but the participants in the control group may benefit from less efficacy. The team may also provide extra treatment after the trial ends. Patients who participate in this trial may experience temporary sourness, numbness, downforce, distension or a sense of soreness during acupuncture treatment and minor bleeding or local bluish skin after acupuncture. The most serious side effect is fainting, but it is rare during clinical appointments.
Where is the study run from?
Outpatient Department of the Oncology and Psychosomatic Medicine Departments in Beijing Hospital of Traditional Chinese Medicine, Capital Medical University in Beijing (China)
When is the study starting and how long is it expected to run for?
January 2022 to December 2025
Who is funding the study?
Beijing Municipal Health Commission (China)
Who is the main contact?
Dr Tingting Ma, tingtingntyy@163.com (China)
Contact information
Principal Investigator
Oncology Department
Beijing Hospital of Traditional Chinese Medicine
No.23, Back Street of Gallery
Dongcheng District
Beijing
100010
China
| Phone | +86 (010)87906735 |
|---|---|
| tingtingntyy@163.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Randomized controlled study on acupuncture therapy of “regulating spirit and soothing liver” for insomnia patients with breast cancer |
| Study objectives | Acupuncture therapy of “regulating spirit and soothing liver” for treating insomnia in patients with breast cancer |
| Ethics approval(s) | Approved 30/09/2022, Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine affiliated with the Capital Medical University (No. 23, Art Museum Back Street, Dongcheng District, Beijing, China; +86 01087906734; bjzyyyllwyh@163.com), ref: 2022BL02-059-02 |
| Health condition(s) or problem(s) studied | Insomnia treatment in patients with breast cancer |
| Intervention | Current interventions as of 13/12/2023: Participants will receive acupuncture therapy for “regulating spirit and soothing liver” for 8 weeks. Time points are as follows: Visit 1: Screening Visit 2: Treatment initiation, participants will receive acupuncture for 8 weeks Visit 3: 8 weeks after first acupuncture, treatment finish and follow-up Visit 4: 1 month after first acupuncture, follow-up Visit 5: 3 months after first acupuncture, follow-up Patients who meet the inclusion criteria are randomized to one of two treatment groups: Group A (receive normal acupuncture at selected acupoints) Group B (receive shallow acupuncture at selected acupoints) 1. Selected acupoints: GV20(Baihui) GV24(Shenting) EX-HN1(Sishencong) GB15(Benshen) Ht7(Shenmen) Pc6(Neiguan) Sp6(Sanyinjiao) St36(Zusanli) Sp10(Xuehai) GB34(Yanglingquan) LR3(Taichong) 2. Normal acupuncture therapy: GV20, GV24, EX-HN1, GB15: The needle tip is inserted 8-15 mm at a 20°angle to the scalp. Sp6, St36, Sp10, GB34: The needle tip is inserted 40 mm at a 90°angle to the skin. Ht7, Pc6, LR3: The needle tip is inserted 20-25 mm at a 20°angle to the skin. Each acupoint is used in neutral supplementation and draining methods and retained for 30 minutes. 3. Shallow acupuncture therapy: The blunt needle on a cotton pad is stuck on the same acupoints as the treatment group and retained for 30 minutes. 4. Treatment will be conducted over a period of 8 weeks, at a frequency of 3 sessions/per week. Previous interventions: Participants will receive acupuncture therapy for “regulating spirit and soothing liver” for 4 weeks. Time points are as follows: Visit 1: Screening Visit 2: Treatment initiation, participants will receive acupuncture for 4 weeks Visit 3: 4 weeks after first acupuncture, treatment finish and follow-up Visit 4: 1 month after first acupuncture, follow-up Visit 5: 3 months after first acupuncture, follow-up Patients who meet the inclusion criteria are randomized to one of four treatment groups: Group A (receive normal acupuncture at selected acupoints) Group B (receive shallow acupuncture at selected acupoints) 1. Selected acupoints: GV20(Baihui) GV24(Shenting) EX-HN1(Sishencong) GB15(Benshen) Ht7(Shenmen) Pc6(Neiguan) Sp6(Sanyinjiao) St36(Zusanli) Sp10(Xuehai) GB34(Yanglingquan) LR3(Taichong) 2. Normal acupuncture therapy: GV20, GV24, EX-HN1, GB15: The needle tip is inserted 8-15 mm at a 20°angle to the scalp. Sp6, St36, Sp10, GB34: The needle tip is inserted 40 mm at a 90°angle to the skin. Ht7, Pc6, LR3: The needle tip is inserted 20-25 mm at a 20°angle to the skin. Each acupoint is used in neutral supplementation and draining methods and retained for 30 minutes. 3. Shallow acupuncture therapy: The blunt needle on a cotton pad is stuck on the same acupoints as the treatment group and retained for 30 minutes. 4. Treatment will be conducted over a period of 4 weeks, at a frequency of 3 sessions/per week. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 13/12/2023: Therapeutic effect measured using the Pittsburgh sleep Scale (PSQI) at baseline (before treatment initiation), 2, 4, 6 and 8 weeks after the first acupuncture, and 1 and 3 months after the last acupuncture session Previous primary outcome measure: Therapeutic effect measured using the Pittsburgh sleep Scale (PSQI) at baseline (before treatment initiation), 2 and 4 weeks after the first acupuncture, and 1 and 3 months after the last acupuncture session |
| Secondary outcome measures | Current secondary outcome measures as of 13/12/2023: Outcome measures are assessed at baseline (before treatment initiation), 2 and 4 weeks after the first acupuncture, and 1 and 3 months after the last acupuncture session unless otherwise stated: 1. Level of anxiety measured using the Generalized Anxiety Disorder (GAD-7) questionnaire 2. Level of anxiety measured using the Patient Health Questionnaire (PHQ9) 3. Serum 5-HT concentration measured using Enzyme-linked immunosorbent assay (ELISA) 4. Temporary sleeping medication use measured using a Temporary Sleeping Medication Record Form 5. Level liver depression measured using TCM Liver Depression Symptom Assessment Table 6. Adverse events, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint, measured using participants reporting up to the 6-week acupuncture session Previous secondary outcome measures: Outcome measures are assessed at baseline (before treatment initiation), 2 and 4 weeks after the first acupuncture, and 1 and 3 months after the last acupuncture session unless otherwise stated: 1. Level of anxiety measured using the Generalized Anxiety Disorder (GAD-7) questionnaire 2. Level of anxiety measured using the Patient Health Questionnaire (PHQ9) 3. Quality of life measured using the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) questionnaire 4. Serum 5-HT concentration measured using Enzyme-linked immunosorbent assay (ELISA) 5. Temporary sleeping medication use measured using a Temporary Sleeping Medication Record Form 6. Level liver depression measured using TCM Liver Depression Symptom Assessment Table 7. Adverse events, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint, measured using participants reporting up to the 6-week acupuncture session |
| Overall study start date | 01/01/2022 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Female |
| Target number of participants | 70 |
| Key inclusion criteria | 1. Aged between 18 and 60 years old and female 2. Confirm the diagnosis of breast cancer and meet the diagnostic criteria for insomnia in DSM-V 3. PSQI score≥10 4. Individuals who do not have a language disorder or mental retardation and can answer and finish the questionnaire smoothly 5. Signed informed consent form and volunteered to participate in this study 6. Individuals who have a correct understanding of acupuncture studies and have good compliance with the observation and evaluation of researchers |
| Key exclusion criteria | 1. Individuals who have epilepsy, diabetes, cardiovascular disease, renal failure, hypertension, metabolic diseases and other major diseases 2. Individuals who have depression, anxiety, schizophrenia and other serious mental disorders with irregular drug use 3. History of sleep apnea syndrome, restless legs syndrome and other sleep disorders 4. Lactating women, pregnant women or women of childbearing age who are planning to become pregnant in a short time 5. Alcoholics and/or psychoactive drug users, drug abusers and dependents 6. Individuals who are afraid or unable to get acupuncture 7. Individuals who take medication or other interventions to sleep regularly for a long time 8. Surgery is scheduled within 1 month |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Dongcheng District
Beijing
100010
China
Sponsor information
Hospital/treatment centre
Affiliated with Capital Medical University
No. 23 Art Museum Back Street
Dongcheng District
Beijing
100010
China
| Phone | +86 01087906734 |
|---|---|
| kycggyx126@126.com | |
| Website | https://www.bjzhongyi.com/ |
"ROR" |
https://ror.org/057vq6e26 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- 北京市卫生健康委员会, Beijing Municipal Bureau of Health, Commission municipale de la Santé de Beijing, BMHB
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Dr Tingting Ma, tingtingntyy@163.com. The estimated date of availability is after 30/06/2025. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 20/02/2023 | No | No | ||
| Other files | 20/02/2023 | No | No |
Additional files
Editorial Notes
13/12/2024: The recruitment end date was changed from 31/12/2024 to 31/08/2025.
13/12/2023: The following changes have been made:
1. The interventions were changed.
2. The primary outcome measure was changed.
3. The secondary outcome measures were changed.
4. The overall study end date was changed from 31/12/2024 to 31/12/2025.
5. The intention to publish date was changed from 01/02/2025 to 31/12/2026.
14/11/2023: ISRCTN confirmed that the registration was initiated on 04/01/2023 and finalised on 20/02/2023. Following the prospective submission in January 2023, there were no subsequent changes to the protocol. The recruitment started on 01/03/2023, after the initiation of public registration.
09/11/2023: The following changes were made to the study records:
1. The recruitment start date was changed from 01/11/2022 to 01/03/2023.
2. The recruitment end date was changed from 31/08/2024 to 31/12/2024.
20/02/2023: Trial's existence confirmed by the Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University.
