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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01881516
• Other study ID #: CIM2013-F
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 13, 2013
• Last updated: June 17, 2013
• Start date: July 2013

Study information

• Verified date: June 2013
• Source: Fudan University
• Contact: jing xie, MD
• Phone: +86 021 64175590
• Email: isable624[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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 ？

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Fatigue Inventory, BFI		12 months	No
Secondary	MDASI-C		12 months	No
Secondary	number of adverse events of acupuncture		24 months	Yes
Secondary	FACT-L		12 months	No