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

Primary Purpose

Lung Cancer, Cancer Related Fatigue

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
acupuncture
sham acupuncture
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Acupuncture

    sham acupuncture

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Brief Fatigue Inventory, BFI

    Secondary Outcome Measures

    MDASI-C
    number of adverse events of acupuncture
    FACT-L

    Full Information

    First Posted
    June 13, 2013
    Last Updated
    June 17, 2013
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01881516
    Brief Title
    Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue(CRF)
    Official Title
    Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue(CRF)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    July 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 ?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer, Cancer Related Fatigue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks
    Arm Title
    sham acupuncture
    Arm Type
    Sham Comparator
    Arm Description
    Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    acupuncture
    Other Intervention Name(s)
    Streitberger needles
    Intervention Description
    once per week for 6 weeks,30 mins for each treatment and for seven main acupoints
    Intervention Type
    Device
    Intervention Name(s)
    sham acupuncture
    Other Intervention Name(s)
    Park Sham Device
    Intervention Description
    the same acupoints and time as in acupuncture arm, but use a Park Sham Device
    Primary Outcome Measure Information:
    Title
    Brief Fatigue Inventory, BFI
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    MDASI-C
    Time Frame
    12 months
    Title
    number of adverse events of acupuncture
    Time Frame
    24 months
    Title
    FACT-L
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    jing xie, MD
    Phone
    +86 021 64175590
    Ext
    3625
    Email
    isable624@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    jing xie, MD
    Organizational Affiliation
    Fudan University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    zhen chen, MD
    Organizational Affiliation
    Fudan University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    qiang zhi meng, MD
    Organizational Affiliation
    Fudan University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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