Back to resultsThe Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
Primary Purpose
Anorexia Nervosa, Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
auricular needling
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring Auricular Needling, Mechanism Study, Anorexia, Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of malignant cancer of stage III or IV
- Meet the diagnosis criteria of cancer induced anorexia
- KPS score≥ 60
- Expected survival time≥3 months
- Willing to give informed consent
- Able to comply with trial protocol
Exclusion Criteria:
- have blood routine, hepatic and renal disfunction,which is over 2 times of the normal value
- obvious eating disorder, intestinal obstruction, poor controlled heart disease and diabetes
- who are receiving progesterone, glucocorticoid or other hormone Therapy
- those who are participating in other trials.
- pregnant women, nursing mother or psychotic patients
Sites / Locations
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Auricular Needling group
control group
Arm Description
Patients will receive auricular needling for 4 weeks .
This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.
Outcomes
Primary Outcome Measures
simple appetite questionnaire
simple appetite questionnaire used to assess the appetite of patient.
symptom based anorexia questionnaire
Secondary Outcome Measures
Fatigue Symptom Inventory
Full Information
NCT ID
NCT02887586
First Posted
August 16, 2016
Last Updated
September 1, 2016
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02887586
Brief Title
The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
Official Title
The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It plays an important role in improving the quality of life among advanced cancer patients. Through a randomized controlled single blinded clinical research, we will observe the differences of appetite, food intake amount, weight and KPS between the auricular needling treating group and control group before and after the treatment. Based on the results of the research, we can prove the clinical effectiveness of auricular needling in treating cancer induced anorexia and possible mechanism of the method.
Detailed Description
Patients will be recruited from Xiyuan Hospital. In this study, eligible participants will be randomly assigned to two groups. In the auricular needling treating group, patients will receive needling treating for 4 weeks(auricular needles are given to one ear every time for 2-3days,then switch to the other). Conventional nutrition support and symptomatic treatment are given at the same time. In the control group, patient just receive conventional nutrition support and symptomatic treatment.
The simple appetite questionnaire, a symptom based Anorexia assessment questionnaire and fatigue symptom inventory questionnaire are used to assess the condition of patients. Other observation index include weight, KPS, appetite and the expectation of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Cancer
Keywords
Auricular Needling, Mechanism Study, Anorexia, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Auricular Needling group
Arm Type
Experimental
Arm Description
Patients will receive auricular needling for 4 weeks .
Arm Title
control group
Arm Type
No Intervention
Arm Description
This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.
Intervention Type
Other
Intervention Name(s)
auricular needling
Intervention Description
Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Smallintestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.
Primary Outcome Measure Information:
Title
simple appetite questionnaire
Description
simple appetite questionnaire used to assess the appetite of patient.
Time Frame
8 weeks
Title
symptom based anorexia questionnaire
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Fatigue Symptom Inventory
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
weight
Time Frame
8 weeks
Title
karnofsky performance score
Description
used to evaluate the physical stamina of patient
Time Frame
8 weeks
Title
acupuncture treating expectation questionnaire
Description
to assess patients' expectation for auricular needling
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of malignant cancer of stage III or IV
Meet the diagnosis criteria of cancer induced anorexia
KPS score≥ 60
Expected survival time≥3 months
Willing to give informed consent
Able to comply with trial protocol
Exclusion Criteria:
have blood routine, hepatic and renal disfunction,which is over 2 times of the normal value
obvious eating disorder, intestinal obstruction, poor controlled heart disease and diabetes
who are receiving progesterone, glucocorticoid or other hormone Therapy
those who are participating in other trials.
pregnant women, nursing mother or psychotic patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin He
Phone
086-13520253895
Email
hebinbj68@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yule Yang
Phone
086-13701366913
Email
yyf93@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin He
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin He
Phone
086-13520253895
Email
hebinbj68@163.com
First Name & Middle Initial & Last Name & Degree
Yule Yang
Phone
086-13701366913
Email
yyf93@vip.sina.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
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