ITMCTR1900002650Not yet recruitingPhase 1
Acupuncture for insomnia in patients with lung cancer: a randomized controlled trial
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 19 to 80 (—)
- Sex
- All
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.
Investigators
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