Acupuncture for Lung Cancer-Related Fatigue

Official title

The Effects of Acupuncture for Lung Cancer-Related Fatigue, a Clinical Trial

Overview

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.

Interventions

• Device Acupuncture
  The main acupoints include Guanyuan (CV4), Zhongwan (CV12), Shangyintang (EX-HN3), bilateral Tianshu (ST25), bilateral Zusanli (ST36), bilateral Hegu (LI4), and bilateral Taichong (LR3). The patient adopts a supine position, and after disinfecting the acupoints, sterile cotton pads are affixed to secure needles. In the experimental group, filiform needles measuring Φ0.30×40mm are inserted into the skin to a depth of 0.5-1 cun, achieving "De Qi" sensation. Needles are retained for 30 minutes. At
• Device Sham Comparator
  The acupoints are same with those in the experimental group. The patient adopts a supine position, and after disinfecting the acupoints, sterile cotton pads are affixed to secure needles. The control group use dull needles measuring 0.30 × 25 mm, which are inserted vertically through the fixed pad until reaching the skin surface. The needles are gently lifted, twisted, and rotated slightly three times each, without piercing the skin. The needles are retained for 30 minutes, with no manipulation

Primary outcome measures

• The proportion of patients whose score of average fatigue over the past 24 hours decreased by at least 2 points on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline. [Time frame: At the 4th week.]

Secondary outcome measures (12)

• The proportion of patients whose score of average fatigue over the past 24 hours decreased by at least 2 points on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline. [Time frame: At the 8, 12, 16 weeks.]
• The change from baseline in the the average fatigue over the past 24 hours on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline. [Time frame: At the 4, 8, 12, and 16 weeks]
• The proportion of patients whose score on the most severe fatigue over the past 24 hours decreased by 2 points or more on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline. [Time frame: At 4, 8, 12, 16 weeks.]
• The change from baseline in the the most severe fatigue over the past 24 hours on the Brief Fatigue Inventory-Chinese (BFI-C) compared to baseline. [Time frame: At the 4, 8, 12, and 16 weeks]
• The changes from baseline of Brief Fatigue Inventory-Chinese (BFI-C) scores on quality of life [Time frame: At 4, 8, 12, 16 weeks.]
• Changes in the scores of the Multidimensional Fatigue Inventory (MFI-20) and the scores of each item compared to the baseline [Time frame: At 4, 8, 12, 16 weeks.]
• Changes in the scores of the Fear of Cancer Recurrence Inventory (FCRI ) compared to the baseline [Time frame: At 4, 8, 12, 16 weeks.]
• Changes in the scores of the Chinese work and social adjustment scale (CWSAS) compared to the baseline [Time frame: At 4, 8, 12, 16 weeks.]
• Changes in the scores of the Patient Health Questionnaire-9 (PHQ-9) compared to the baseline [Time frame: At 4, 8, 12, 16 weeks.]
• Changes in the scores of the Generalized Anxiety Disorder-7 (GAD-7) compared to the baseline [Time frame: At 4, 8, 12, 16 weeks.]
• Changes in the scores of the Insomnia Severity Index (ISI) compared to the baseline [Time frame: At 4, 8, 12, 16 weeks.]
• The percentage of patients who experienced moderate or significant improvement in fatigue, as evaluated by the Patient Global Impression-Improvement (PGI-I) scale. [Time frame: At 4, 16 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07079072 · 2025-074-KY-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗