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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002650
Enrollment
Unknown
Registered
2019-10-08
Start date
2019-12-25
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

lung cancer-related insomnia

Interventions

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index(PSQI);

Secondary

MeasureTime frame
wActiSleep-BT wireless sleep monitor;Quality of Life Questionnaire Core-30;Patient Health Questionnaire-9;

Countries

China

Contacts

Public ContactXu Shifen

Shanghai Municipal Hospital of Traditional Chinese Medicine

xu_teacher2006@126.com+86 13761931393

Outcome results

None listed

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