Clinical trial NCT02887586: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Cancer
Keywords: Auricular Needling
Mechanism Study
Anorexia
Cancer
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of malignant cancer of stage III or IV
* Meet the diagnosis criteria of cancer induced anorexia
* Karnofsky performance status(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

Primary outcomes:
measure: Simple Appetite Questionnaire
timeFrame: 10 weeks
measure: Symptom Based Anorexia Assessment
timeFrame: 10 weeks
Secondary outcomes:
measure: Appetite Improvement
timeFrame: 10 weeks
measure: Weight
timeFrame: 10 weeks
measure: Acupuncture Treating Expectation Questionnaire
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Bin He
role: PRINCIPAL_INVESTIGATOR
References: