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A Randomized Controlled Trial of Acupuncture for Cancer-Related Fatigue in Patients with Advanced Lung Cancer

Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001236
Enrollment
Unknown
Registered
2025-06-21
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

lung cancer

Interventions

Sponsors

Guang'anmen Hospital Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-75 years; 2) ECOG/PS score of grade 0-1 and expected survival = 3 months; 3) Non-small cell lung cancer AJCC lung cancer staging of stage IIIB-IV or small cell lung cancer staging of extensive stage; 4) Those with low or negative PD-L1 expression (TPS 1 cm) or lymph node short diameter = 1.5 cm; 9) Signed an informed consent form to voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: 1) Combined with other primary malignant tumors; 2) Those who have contraindications to immunotherapy after basic evaluation of immunotherapy pre-treatment; 3) Those who have autoimmune system diseases or need long-term treatment with systemic steroids or immunosuppressants; 4) Combined with serious and uncontrolled cardiac, cerebrovascular, hepatic, renal, hematopoietic, and other primary diseases; 5) Those with metal allergy or severe fear of needles; 6) Those who are pregnant or breastfeeding; 7) Those with mental disorder or intellectual or speech impairment that prevents them from cooperating to complete the assessment; 8) Those with active severe infectious or inflammatory diseases; 9) Those who had received acupuncture treatment or other clinical trials within 1 month prior to randomization; 10) Persons who, in the judgment of the investigator, have a concomitant medical condition that seriously jeopardizes the safety of the participant or interferes with the completion of the study or who are deemed to have other reasons for not being suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Brief Fatigue Inventory;Fatigue Visual Analog Score;

Secondary

MeasureTime frame
Lung Cancer Symptom Scale;Patient Health Questionnaire-9;Disease Control Rate;Eastern Cooperative Oncology Group Performance Status;Insomnia Severity Index;Adverse Event;Objective Response Rate;Generalized Anxiety Disorder-7;

Countries

China

Contacts

Public ContactZhishun Liu

Guang'anmen Hospital Chinese Academy of Traditional Chinese Medicine

zhishunjournal@163.com18811189057

Outcome results

None listed

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