The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia

Conditions
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Anorexia Nervosa, Cancer

Intervention / Treatment
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* Other: auricular needling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular Needling group<br>Patients will receive auricular needling for 4 weeks . | Other: auricular needling<br>* 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.<br>|
| No Intervention: control group<br>This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| simple appetite questionnaire | simple appetite questionnaire used to assess the appetite of patient. | 8 weeks | 
| symptom based anorexia questionnaire |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Symptom Inventory |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auricular Needling, Mechanism Study, Anorexia, Cancer