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
About this trial
This is an interventional treatment trial for Lung Cancer
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.
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
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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