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Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue(CRF)

Phase 2
18 Years
65 Years
Not Enrolling
Lung Cancer, Cancer Related Fatigue

Thank you

Trial Information

Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue(CRF)

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Brief Fatigue Inventory, BFI

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

jing xie, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

shanghai cancer center, fudan university


China: Ethics Committee

Study ID:




Start Date:

July 2013

Completion Date:

Related Keywords:

  • Lung Cancer
  • Cancer Related Fatigue
  • Fatigue
  • Lung Neoplasms