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

NCT ID: NCT02887586

Last Updated: 2024-01-30

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-12-31

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.

Conditions

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Anorexia Nervosa Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Auricular Needling group

Patients will receive auricular needling for 4 weeks .

Group Type EXPERIMENTAL

auricular needling

Intervention Type OTHER

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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bin He

Role: PRINCIPAL_INVESTIGATOR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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81573958

Identifier Type: -

Identifier Source: org_study_id

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