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

NCT ID: NCT01881516

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31

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 ？

Conditions

Lung Cancer; Cancer Related Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acupuncture

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

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: DEVICE

once per week for 6 weeks，30 mins for each treatment and for seven main acupoints

sham acupuncture

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

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: DEVICE

the same acupoints and time as in acupuncture arm, but use a Park Sham Device

Interventions

acupuncture

once per week for 6 weeks，30 mins for each treatment and for seven main acupoints

Intervention Type: DEVICE

sham acupuncture

the same acupoints and time as in acupuncture arm, but use a Park Sham Device

Intervention Type: DEVICE

Other Intervention Names

Streitberger needles; Park Sham Device

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

xie jing

attending

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

jing xie, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

zhen chen, MD

Role: STUDY_DIRECTOR

Fudan University

qiang zhi meng, MD

Role: STUDY_CHAIR

Fudan University

Central Contacts

jing xie, MD

Role: CONTACT

isable624@163.com

+86 021 64175590 ext. 3625

Other Identifiers

CIM2013-F

Identifier Type: -

Identifier Source: org_study_id