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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental |
| |
| sham acupuncture | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the 4th week. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the 8, 12, 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of patient's expected benefit from acupuncture treatment | Ask the patient, "How do you expect your fatigue to be after four weeks?" Choose from the following options: significantly improved, improved, unsure, unchanged, or worsened. | At 0 week. |
| Assessment of belief in acupuncture |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiarong Fan | Contact | +8618811189057 | fjrr1115@163.com |
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Deidentified participant data and data dictionary will be available with the publication until six months after publication.
Deidentified participant data and data dictionary will be available with the publication until six months after publication.
A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham Comparator | Device | 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 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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to the end of follow-up at 16 weeks |
Ask the patient, "Do you believe that acupuncture therapy helps in managing your fatigue? " Choose from the following options: ineffective, not very effective, uncertain, somewhat effective, highly effective. |
| At 0, 4, 16 week. |
| Blinding assessment | Ask the patient, "The treatment you received over the past 4 weeks was tradition acupuncture or not?" | Assessment occurs within 5 minutes after the final acupuncture session of any treatment in the last week. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |