Cancer Related Fatigue, Lung Cancer
Conditions
Brief 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 ？
Interventions
DEVICEacupuncture
once per week for 6 weeks，30 mins for each treatment and for seven main acupoints
DEVICEsham acupuncture
the same acupoints and time as in acupuncture arm, but use a Park Sham Device
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief Fatigue Inventory, BFI | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| MDASI-C | 12 months |
| number of adverse events of acupuncture | 24 months |
| FACT-L | 12 months |
Contacts
Primary Contactjing xie, MD
Outcome results
None listed