NCT02887586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

August 16, 2016

Results QC Date

February 26, 2022

Last Update Submit

January 25, 2024

Conditions

Anorexia NervosaCancer

Keywords

Auricular NeedlingMechanism StudyAnorexiaCancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Appetite Improvement

    10 weeks

  • Weight

    10 weeks

  • Acupuncture Treating Expectation Questionnaire

    10 weeks

Study Arms (2)

Auricular Needling group

EXPERIMENTAL

Patients will receive auricular needling for 4 weeks .

Other: auricular needling

control group

NO INTERVENTION

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

Interventions

auricular needlingOTHER

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.

Auricular Needling group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Anorexia NervosaNeoplasmsAnorexia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Hebin
Organization
Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences
hebinbj68@163.com
13520253895

Study Officials

  • Bin He

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

September 2, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2017-12

Locations

CN(1)