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

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ClinicalTrials.gov Identifier: NCT01881516
Recruitment Status : Unknown
Verified June 2013 by xie jing, Fudan University.
Recruitment status was:  Not yet recruiting
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
xie jing, Fudan University

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 ?

Condition or disease Intervention/treatment Phase
Lung Cancer Cancer Related Fatigue Device: acupuncture Device: sham acupuncture Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue(CRF)
Study Start Date : July 2013
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Acupuncture
Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks
Device: acupuncture
once per week for 6 weeks,30 mins for each treatment and for seven main acupoints
Other Name: Streitberger needles

Sham Comparator: sham acupuncture
Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.
Device: sham acupuncture
the same acupoints and time as in acupuncture arm, but use a Park Sham Device
Other Name: Park Sham Device




Primary Outcome Measures :
  1. Brief Fatigue Inventory, BFI [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. MDASI-C [ Time Frame: 12 months ]
  2. number of adverse events of acupuncture [ Time Frame: 24 months ]
  3. FACT-L [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881516


Contacts
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Contact: jing xie, MD +86 021 64175590 ext 3625 isable624@163.com

Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: jing xie, MD Fudan University
Study Director: zhen chen, MD Fudan University
Study Chair: qiang zhi meng, MD Fudan University

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Responsible Party: xie jing, attending, Fudan University
ClinicalTrials.gov Identifier: NCT01881516     History of Changes
Other Study ID Numbers: CIM2013-F
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Lung Neoplasms
Fatigue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms