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

Overview

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 ?

Full Title of Study: “Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue(CRF)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2014

Interventions

  • Device: acupuncture
    • once per week for 6 weeks,30 mins for each treatment and for seven main acupoints
  • Device: sham acupuncture
    • the same acupoints and time as in acupuncture arm, but use a Park Sham Device

Arms, Groups and Cohorts

  • Active Comparator: Acupuncture
    • Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks
  • Sham Comparator: sham acupuncture
    • Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Brief Fatigue Inventory, BFI
    • Time Frame: 12 months

Secondary Measures

  • MDASI-C
    • Time Frame: 12 months
  • number of adverse events of acupuncture
    • Time Frame: 24 months
  • FACT-L
    • Time Frame: 12 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: xie jing, attending – Fudan University
  • Overall Official(s)
    • jing xie, MD, Principal Investigator, Fudan University
    • zhen chen, MD, Study Director, Fudan University
    • qiang zhi meng, MD, Study Chair, Fudan University
  • Overall Contact(s)
    • jing xie, MD, +86 021 64175590, isable624@163.com

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