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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Cancer Related Fatigue; Lung Cancer

Treatments: Device: sham acupuncture; Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01881516

CIM2013-F

Details and patient eligibility

About

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 ？

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups

Acupuncture

Active Comparator group

Description:

Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks

Treatment:

Device: acupuncture

sham acupuncture

Sham Comparator group

Description:

Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.

Treatment:

Device: sham acupuncture