Acupuncture for Lung Cancer-Related Fatigue

NCT07079072 | Not Yet Recruiting

• 1 other identifier: 2025-074-KY-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

lung cancer; cancer-related fatigue; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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 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 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 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 changes from baseline of Brief Fatigue Inventory-Chinese (BFI-C) scores on quality of life

  At 4, 8, 12, 16 weeks.

Other Outcomes (3)

• Assessment of patient's expected benefit from acupuncture treatment

  At 0 week.

• Assessment of belief in acupuncture

  At 0, 4, 16 week.

• Blinding assessment

  Assessment occurs within 5 minutes after the final acupuncture session of any treatment in the last week.

Study Arms (2)

Acupuncture

EXPERIMENTAL

Device: Acupuncture

sham acupuncture

SHAM COMPARATOR

Device: Sham Comparator

Interventions

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.

Acupuncture

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.

sham acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Jiarong Fan

CONTACT

+8618811189057; fjrr1115@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Deidentified participant data and data dictionary will be available with the publication until six months after publication.
• Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.