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

Not Applicable

• Conditions: Cancer-related Insomnia

• Registration Number: ITMCTR2000003094
• Lead Sponsor: Yueyang Hospital of integrated traditional Chinese and Western Medicine Affiliated to Shanghai University of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia treatment effectiveness;Insomnia Severity Index;Pittsburgh Sleep Quality Index;

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Scale;EORTC QLQ-C30;Hamilton Anxiety Scale;