Acupuncture for Lung Cancer-Related Fatigue

ConditionLung Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: AcupunctureExperimental treatment 1 intervention

Group B: sham acupunctureSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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

Other outcomes

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.

Time frame

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.

Time frame

At 0, 4, 16 week.

Blinding assessment

Ask the patient, "The treatment you received over the past 4 weeks was tradition acupuncture or not?"

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

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