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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Anorexia Nervosa; Cancer

Treatments: Other: auricular needling

Study type: Interventional

Funder types: Other

Identifiers

NCT02887586

81573958

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Auricular Needling group

Experimental group

Description:

Patients will receive auricular needling for 4 weeks .

Treatment:

Other: auricular needling

control group

No Intervention group

Description:

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