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

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ClinicalTrials.gov Identifier: NCT02887586
Recruitment Status : Unknown
Verified May 2016 by Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : September 2, 2016
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Cancer Other: auricular needling Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
Study Start Date : August 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Auricular Needling group
Patients will receive auricular needling for 4 weeks .
Other: auricular needling
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.

No Intervention: control group
This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.



Primary Outcome Measures :
  1. simple appetite questionnaire [ Time Frame: 8 weeks ]
    simple appetite questionnaire used to assess the appetite of patient.

  2. symptom based anorexia questionnaire [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Fatigue Symptom Inventory [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. weight [ Time Frame: 8 weeks ]
  2. karnofsky performance score [ Time Frame: 8 weeks ]
    used to evaluate the physical stamina of patient

  3. acupuncture treating expectation questionnaire [ Time Frame: 8 weeks ]
    to assess patients' expectation for auricular needling



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02887586


Contacts
Contact: Bin He 086-13520253895 hebinbj68@163.com
Contact: Yule Yang 086-13701366913 yyf93@vip.sina.com

Locations
China, Beijing
Xiyuan Hospital of China Academy of Chinese Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100029
Contact: Bin He    086-13520253895    hebinbj68@163.com   
Contact: Yule Yang    086-13701366913    yyf93@vip.sina.com   
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Bin He Xiyuan Hospital of China Academy of Chinese Medical Sciences

Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02887586     History of Changes
Other Study ID Numbers: 81573958
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Xiyuan Hospital of China Academy of Chinese Medical Sciences:
Auricular Needling
Mechanism Study
Anorexia
Cancer

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders