Acupuncture for Lung Cancer-Related Fatigue

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

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 Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Acupuncture; Device: Sham Comparator

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiarong Fan; Phone Number: +8618811189057; Email: fjrr1115@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture	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 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.
Sham Comparator: sham acupuncture	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 during this period. The participants received 12 sham acupuncture sessions over a 4-week period, with three sessions per week scheduled every other day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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
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.
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
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.
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.

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 13, 2025
• First Submitted That Met QC Criteria: July 13, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer; acupuncture; cancer-related fatigue
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Fatigue
• Other Study ID Numbers: 2025-074-KY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data and data dictionary will be available with the publication until six months after publication.
• IPD Sharing Time Frame: Deidentified participant data and data dictionary will be available with the publication until six months after publication.
• IPD Sharing Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No