Skip to main content
OpenTrials
Completed

NCT Number: NCT02887586

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anorexia Nervosa Anorexia Cancer Feeding and Eating Disorders Mental Disorders Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

auricular needling

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.

Primary outcomes

  1. Simple Appetite Questionnaire

    Time frame: 10 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.

  2. Symptom Based Anorexia Assessment

    Time frame: 10 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 outcomes

  1. Appetite Improvement

    Time frame: 10 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"

  2. Weight

    Time frame: 10 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.

  3. Acupuncture Treating Expectation Questionnaire

    Time frame: 10 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).

Sponsors and collaborators

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2016
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.