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

Not Applicable
Completed
Conditions
Cancer
Anorexia Nervosa
Interventions
Other: auricular needling
Registration Number
NCT02887586
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Auricular Needling groupauricular needlingPatients will receive auricular needling for 4 weeks .
Primary Outcome Measures
NameTimeMethod
Simple Appetite Questionnaire10 weeks

The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess the patient's appetite.Possible scores range from 4(poor appetite) to20(good appetite).The score lower than 14 predicts a risk of 5% weight loss.

Symptom Based Anorexia Assessment10 weeks

Symptom based anorexia assessment is used to evaluate whether and to what extent anorexia occurs in cancer patients.Possible scores range from 0(normal appetite) to 48(severe anorexia).After the patient answers all the questions in the table, the score is scored, and the final score is less than or equal to 24 points, which can be determined as anorexia.

Secondary Outcome Measures
NameTimeMethod
Appetite Improvement10 weeks

The appetite improvement is used to indicates the patient's appetite.Method: Use a moving ruler about 10cm long, with one side marked with 10 scales, the two ends are "0" and "10" respectively, 0 means normal appetite, 10 scores indicate extreme aversion to food. When in use, the side with the scale should face away from the patient, and let the patient mark on the ruler.The corresponding position that can represent one's own desire for food, the position marked by the doctor according to the patient is its score, clinical evaluation is divided into "normal appetite/basically normal eaters", "3-5" with "0-2".

Divided into "mild anorexia", "6-8" into "moderate anorexia", \>8 into "severe anorexia"

Weight10 weeks

Weight used to assess the appetite of patient.Body weight changes caused by factors such as body cavity effusion and edema were excluded. Improvement: weight gain \> 2kg,and maintained for more than 4 weeks. Stable: Weight gain or loss ≤ 2kg. Exacerbation: Weight loss \> 2kg.

Acupuncture Treating Expectation Questionnaire10 weeks

Acupuncture treating expectation questionnaire used to assess patients' expectation for auricular needling.Higher scores indicate higher expectations.Possible scores range from 4(low expectations) to 20(high expectations).

Trial Locations

Locations (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

🇨🇳

Beijing, Beijing, China

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