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

Fudan University logo

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

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

Trial contacts and locations

0

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Central trial contact

jing xie, MD

Data sourced from clinicaltrials.gov

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