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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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 each acupoint (except Shangyintang), manual stimulation including lifting, thrusting, twisting, and plucking is performed once every 10 minutes. The participants received 12 acupuncture sessions over a 4-week period, with three sessions per week scheduled every other day.
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 during this period. The participants received 12 sham acupuncture sessions over a 4-week period, with three sessions per week scheduled every other day.
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.
The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more severe fatigue.
Time frame: At the 4th week.
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.
The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more severe fatigue.
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.
The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more
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.
The total scores for the highest level of fatigue range from 0 to 10 points, higher scores indicating more severe fatigue.
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.
The severity of fatigue is scored on a scale from 0 to 10, higher scores indicating more severe fatigue.
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
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.
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
Each item scores from 1 to 5 points, the total score ranging from 20 to 100 points, higher scores indicating more severe fatigue.
Time frame: At 4, 8, 12, 16 weeks.
Changes in the scores of the Fear of Cancer Recurrence Inventory (FCRI ) compared to the baseline
Each item scores from 0 to 4 points, the total score ranging from 0 to 36 points, higher scores indicating more fear.
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
Each item scores from 0 to 8 points, the total score ranging from 0 to 40 points, higher scores indicating more fear.
Time frame: At 4, 8, 12, 16 weeks.
Changes in the scores of the Patient Health Questionnaire-9 (PHQ-9) compared to the baseline
The total score range is 0-27 points, higher scores indicates more severe depression.
Time frame: At 4, 8, 12, 16 weeks.
Changes in the scores of the Generalized Anxiety Disorder-7 (GAD-7) compared to the baseline
The total score range is 0-21 points, higher scores indicates more severe anxiety.
Time frame: At 4, 8, 12, 16 weeks.
Changes in the scores of the Insomnia Severity Index (ISI) compared to the baseline
The total score range is 0-28 points, higher scores indicates worse results.
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.
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.
Time frame: At 4, 16 weeks.
Adverse event
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.
Time frame: From enrollment to the end of follow-up at 16 weeks
Adherence assessment
The proportion of subjects who completed 80% or more of acupuncture treatments.
Time frame: From enrollment to the end of follow-up at 16 weeks
Concomitant medication
The proportion of patients taking other medications and treatment that could influence fatigue treatment results.
Time frame: From enrollment to the end of follow-up at 16 weeks
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