Acupuncture for insomnia in patients with lung cancer: a randomized controlled trial

Phase 1

• Conditions: lung cancer-related insomnia

• Registration Number: ITMCTR1900002650
• Lead Sponsor: Shanghai Municipal Hospital 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. Male or female patients aged between 19 to 80 years old;
2. Diagnosed with pulmonary malignancy according to imaging result and histologic examination;
3. Continuous insomnia related to lung cancer treatment or cancer itself for at least 3 months, and meet the diagnostic criteria of insomnia according to International Classification of Sleep Disorders-Third Edition (ICSD-3) from American Academy of Sleep Medicine;
4. An Eastern Cooperation Oncology Group (ECOG) performance status is less than 2;
5. Scores of Pittsburgh Sleep Quality Index (PSQI) is more than 11;
6. Cessation of cancer-related treatment (surgery, chemotherapy and radiotherapy) at least 4 weeks before the trial and inspections show pulmonary malignancy in stable condition (no plan to accept above treatment in 8 weeks after entering this trial);
7. No acupuncture experience in the previous 12 months;
8. Willing to participate in the trial and having provided written consent.

Exclusion Criteria

1. A diagnosis of secondary insomnia caused by depression, anxiety or other psychiatric disorders and addition of caffeine, alcohol or drugs.
2. Index of cancer pain measured by the numeric rating scale>=4;
3. An estimated survival time <= 6 months; Or bedridden all day;
4. A diagnosis of psychiatric disorder, or severe cognitive deficit failing to cooperate;
5. A diagnosis of severe disease of the cardiovascular, hepatic, renal, cerebrovascular, or hematopoietic systems;
6. Pregnant or breastfeeding women;
7. Having participant in other clinic trials within 4 weeks before this trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index(PSQI);

Secondary Outcome Measures

Name	Time	Method
wActiSleep-BT wireless sleep monitor;Quality of Life Questionnaire Core-30;Patient Health Questionnaire-9;