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A randomized controlled clinical study: clinical efficacy observation and safety evaluation of acupuncture in the treatment of cancer related insomnia

A randomized controlled clinical study: clinical efficacy observation and safety evaluation of acupuncture in the treatment of cancer related insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003094
Enrollment
Unknown
Registered
2020-03-07
Start date
2020-03-31
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-related Insomnia

Interventions

Experimental group:Acupuncture

Sponsors

Yueyang Hospital of integrated traditional Chinese and Western Medicine Affiliated to Shanghai University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Patients who has been diagnosed malignant tumors by histopathology or cytology; 2. Patients with the insomnia related to cancer treatment or cancer itself has lasted for at least 2 months, meeting the diagnostic criteria for insomnia ; 3. With total insomnia severity index (ISI) score >= 10 points or Pittsburgh sleep Therapeutic Index (PSQI)> 5 points; 4. Patients aged >= 45 years and <= 74 years, no gender restriction; 5. Patients who volunteer to participate in the study and sign informed consent; 6. Patients have clear awareness and ability to judge their symptoms and conditions, and able to cooperate to fill out the scale accurately.

Exclusion criteria

Exclusion criteria: 1. Patients who have been diagnosed as Major Depression, Anxiety, Panic Disorder, or other mental illness; Caffeine, Alcohol, or Drug Addiction; Hamilton Anxiety and Depression Scale Score >= 11; 2. Cancer pain measured by digital rating scale >= 4 points; 3. Patients with serious cardiovascular, respiratory, digestive or hematopoietic diseases, hemophilia or various bleeding disorders; 4. Patients using pacemakers or anticoagulants; 5. Pregnant or lactating women; 6. Patients who stun or cannot tolerate acupuncture; 7. Patients with local ulceration or infection in the treatment area 8. Patients with severe cognitive impairment, difficulty in self judging the severity of symptoms, and mental disorders; 9. Patients who underwent tumor-related surgery, chemotherapy or radiotherapy in the past month.

Design outcomes

Primary

MeasureTime frame
Insomnia treatment effectiveness;Insomnia Severity Index;Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Hamilton Depression Scale;EORTC QLQ-C30;Hamilton Anxiety Scale;

Countries

China

Contacts

Public ContactJiaqi Li

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

jackytcm@163.com+86 13764059754

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026