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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887586
• Other study ID #: 81573958
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simple Appetite Questionnaire	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.	10 weeks
Primary	Symptom Based Anorexia Assessment	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.	10 weeks
Secondary	Appetite Improvement	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"	10 weeks
Secondary	Weight	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.	10 weeks
Secondary	Acupuncture Treating Expectation Questionnaire	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).	10 weeks