Acupuncture for Lung Cancer-Related Fatigue

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer

• Registration Number: NCT07079072
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-13
• Study First Posted: 2025-07-22
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Study Start: 2025-08-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	At the 4th week.	The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more severe fatigue.

Secondary Outcome Measures

Name	Time	Method
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.	At the 8, 12, 16 weeks.	The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more severe fatigue.
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.	At the 4, 8, 12, and 16 weeks	The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more
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.	At 4, 8, 12, 16 weeks.	The total scores for the highest level of fatigue range from 0 to 10 points, higher scores indicating more severe fatigue.
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.	At the 4, 8, 12, and 16 weeks	The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more severe fatigue.
The changes from baseline of Brief Fatigue Inventory-Chinese (BFI-C) scores on quality of life	At 4, 8, 12, 16 weeks.	The impact of cancer-related fatigue on patients' quality of life is assessed by BFI-C in daily activities, mood, mobility, work, relationships and interests. The score ranges from 0 to 10, with higher score indicating greater impact.
Changes in the scores of the Multidimensional Fatigue Inventory (MFI-20) and the scores of each item compared to the baseline	At 4, 8, 12, 16 weeks.	Each item scores from 1 to 5 points, the total score ranging from 20 to 100 points, higher scores indicating more severe fatigue.
Changes in the scores of the Fear of Cancer Recurrence Inventory (FCRI ) compared to the baseline	At 4, 8, 12, 16 weeks.	Each item scores from 0 to 4 points, the total score ranging from 0 to 36 points, higher scores indicating more fear.
Changes in the scores of the Chinese work and social adjustment scale (CWSAS) compared to the baseline	At 4, 8, 12, 16 weeks.	Each item scores from 0 to 8 points, the total score ranging from 0 to 40 points, higher scores indicating more fear.
Changes in the scores of the Patient Health Questionnaire-9 (PHQ-9) compared to the baseline	At 4, 8, 12, 16 weeks.	The total score range is 0-27 points, higher scores indicates more severe depression.
Changes in the scores of the Generalized Anxiety Disorder-7 (GAD-7) compared to the baseline	At 4, 8, 12, 16 weeks.	The total score range is 0-21 points, higher scores indicates more severe anxiety.
Changes in the scores of the Insomnia Severity Index (ISI) compared to the baseline	At 4, 8, 12, 16 weeks.	The total score range is 0-28 points, higher scores indicates worse results.
The percentage of patients who experienced moderate or significant improvement in fatigue, as evaluated by the Patient Global Impression-Improvement (PGI-I) scale.	At 4, 16 weeks.	The PGI-I is a patient-reported subjective assessment of their condition, consisting of seven levels: markedly worse, somewhat worse, moderately worse, no change, slightly improved, moderately improved, and markedly improved. The proportion of patients who report moderately improved or markedly improved will be calculated.
Adverse event	From enrollment to the end of follow-up at 16 weeks	Collect adverse events occurring during treatment and follow-up periods, including acupuncture-related adverse events and other adverse events classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Adherence assessment	From enrollment to the end of follow-up at 16 weeks	The proportion of subjects who completed 80% or more of acupuncture treatments.
Concomitant medication	From enrollment to the end of follow-up at 16 weeks	The proportion of patients taking other medications and treatment that could influence fatigue treatment results.