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

NCT01881516 | Unknown Phase 2 DMC

• 1 other identifier: CIM2013-F
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Brief Fatigue Inventory, BFI

  12 months

Secondary Outcomes (3)

• MDASI-C

  12 months

• number of adverse events of acupuncture

  24 months

• FACT-L

  12 months

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

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

Device: acupuncture

sham acupuncture

SHAM COMPARATOR

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

Device: sham acupuncture

Interventions

acupuncture DEVICE

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

Also known as: Streitberger needles

Acupuncture

sham acupuncture DEVICE

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

Also known as: Park Sham Device

sham acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• jing xie, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• zhen chen, MD

  Fudan University

  STUDY DIRECTOR

• qiang zhi meng, MD

  Fudan University

  STUDY CHAIR

Central Study Contacts

jing xie, MD

CONTACT

+86 021 64175590; isable624@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 19, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Last Updated: June 19, 2013

Record last verified: 2013-06