Acupuncture for Lung Cancer-Related Fatigue

July 22, 2025 updated by: Yuanjie Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: At the 4th week.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 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.
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 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.
Time Frame: 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.
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 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
Time Frame: 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.
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.
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
Time Frame: 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.
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.
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
Time Frame: At 4, 8, 12, 16 weeks.
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
Time Frame: At 4, 8, 12, 16 weeks.
The total score range is 0-28 points, higher scores indicates worse results.
At 4, 8, 12, 16 weeks.
Adverse event
Time Frame: 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.
From enrollment to the end of follow-up at 16 weeks
Adherence assessment
Time Frame: From enrollment to the end of follow-up at 16 weeks
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
Time Frame: 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.
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
Time Frame: 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.
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.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of patient's expected benefit from acupuncture treatment
Time Frame: At 0 week.
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
Time Frame: At 0, 4, 16 week.
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
Time Frame: Assessment occurs within 5 minutes after the final acupuncture session of any treatment in the last week.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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