Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue（CRF）

Phase 2

• Conditions: Lung Cancer; Cancer Related Fatigue
• Interventions: Device: acupuncture; Device: sham acupuncture

• Registration Number: NCT01881516
• Lead Sponsor: Fudan University

Brief Summary

we plan to conduct this trial to find out：

* If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or radio-therapy？

* How about the extent it relieves？the safety and applicability ？

* What's the possible influential factor and mechanism ？

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-17
• Last Update Submitted: 2013-06-17
• Study First Posted: 2013-06-19
• Last Update Posted: 2013-06-19
• Study Start: 2013-07
• Primary Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients who are pathologically/cytologically diagnosed as NSCLC and received radiotherapy with or without chemotherapy, and the last radio- or chemo-therapy must be at least 30 days prior to initiation of experimental treatment;
• Participants who meet the diagnosis criteria of CRF（ICD-10 criteria);
• The first time to receive acupuncture treatment;
• The age is between 18 and 65 years old;
• Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above;
• ECOG performance status 0, 1 or 2.
• Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L.
• Have not taken any hypnotic, melatonin, or antidepressants within 30 days;
• Willing to finish the whole observation period;
• With written consent form signed by themselves.

Exclusion Criteria

• Participants in other clinical research;
• Can not be pathologically or cytologically diagnosed as NSCLC;
• ECOG 3~4;
• Pregnant woman;
• >65 or <18 years old;
• Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue;
• Patients who have received acupuncture ever before;
• Received surgery, immunotherapy or target therapy within one month before the recruition；
• Taking warfarin or heparin, a bleeding tendency exists;
• Infection, ulceration or hyperalgesia at or near the local acupoints' skin，or with active infections；
• There are cerebral vascular accident history or spinal cord injury history；
• Combination with other serious diseases or condition, including congestive heart failure, Unstable angina pectoris, myocardial infarction during the past six months, serious's arrhythmia, mental disorders, drug abuse, etc.;
• Patients with a life expectancy < 3 months;
• Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	acupuncture	Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks
sham acupuncture	sham acupuncture	Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Brief Fatigue Inventory, BFI	12 months

Secondary Outcome Measures

Name	Time	Method
MDASI-C	12 months
number of adverse events of acupuncture	24 months
FACT-L	12 months