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

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

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 ？

Study Overview

• Status: Unknown
• Conditions: Lung Cancer; Cancer Related Fatigue
• Intervention / Treatment: Device: acupuncture; Device: sham acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acupuncture; Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks	Device: acupuncture; once per week for 6 weeks，30 mins for each treatment and for seven main acupoints; Other Names: Streitberger needles
Sham Comparator: sham acupuncture; Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.	Device: sham acupuncture; the same acupoints and time as in acupuncture arm, but use a Park Sham Device; Other Names: Park Sham Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Brief Fatigue Inventory, BFI	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
MDASI-C	12 months
number of adverse events of acupuncture	24 months
FACT-L	12 months

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: jing xie, MD, Fudan University; Study Director: zhen chen, MD, Fudan University; Study Chair: qiang zhi meng, MD, Fudan University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: June 13, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Fatigue; Lung Neoplasms
• Other Study ID Numbers: CIM2013-F