Acupuncture for Lung Cancer-Related Fatigue

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status

Not yet enrolling

Conditions

Lung Cancer

Treatments

Device: Sham Comparator

Device: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT07079072

2025-074-KY-01

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of acupuncture in alleviating cancer-related fatigue (CRF) among lung cancer survivors. It addresses the key issue of limited high-quality evidence for acupuncture's effect on CRF by rigorously comparing real acupuncture against a non-penetrating sham needle control in 120 eligible participants. Patients will be centrally randomized (1:1), blinded, and receive 12-session treatment over 4 weeks. Participants will complete treatment and attend follow-up visits up to week 16, and repeatedly complete fatigue (BFI-C, MFI-20), psychological (PHQ-9, GAD-7, FCRI), functional (CWSAS), and sleep (ISI) assessments.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a history of lung cancer who have completed initial treatment (including surgery, radiotherapy, and/or chemotherapy) at least 8 weeks prior;
Aged between 18 and 75 years;
Meet the diagnostic criteria for cancer-related fatigue;
Estimated to have a survival period of at least 3 months;
Patients with moderate to severe cancer-related fatigue (the highest fatigue score in the past 24 hours on the Chinese version of the Brief Fatigue Inventory [BFI-C] ≥ 4 points);
ECOG Performance Status score ranges from 0 to 2 points
Voluntarily join this study and sign the informed consent form.

Exclusion criteria

Patients experiencing significant fatigue symptoms before being diagnosed with lung cancer;
Patients with severe anxiety and depression;
Patients showing notable cognitive impairment or suicidal tendencies;
Patients with a history of hypothyroidism or chronic fatigue syndrome;
Patients suffering from moderate to severe anemia, with hemoglobin levels below 90 g/L;
Patients experiencing severe pain, with a Numeric Rating Scale (NRS) score of 7 or higher;
Patients with serious sleep disorders;
Patients with severe malnutrition;
Patients with seriously diminished physical function;
Patients who have undergone acupuncture treatment for cancer-related fatigue within the past month;
Patients with uncontrolled severe underlying conditions, such as heart failure, myocardial infarction, unstable angina, endocrine disorders, gastrointestinal issues, neurological impairments, severe infections, liver and kidney failure, or chronic obstructive pulmonary disease;
Patients with poor adherence;
Patients who are breastfeeding, pregnant, or planning to conceive within the next four months.