Clinical trial NCT01881516: Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue（CRF）
Official title: Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue（CRF）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Cancer Related Fatigue
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ？


Eligibility criteria: 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.

Primary outcomes:
measure: Brief Fatigue Inventory, BFI
timeFrame: 12 months
Secondary outcomes:
measure: MDASI-C
timeFrame: 12 months
measure: number of adverse events of acupuncture
timeFrame: 24 months
measure: FACT-L
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: jing xie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: zhen chen, MD
role: STUDY_DIRECTOR
affiliation: Fudan University
name: qiang zhi meng, MD
role: STUDY_CHAIR
References: