Anorexia NervosaNCT02887586
The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
A study testing auricular needling in people with Anorexia Nervosa and Cancer, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anorexia Nervosa, Cancer
- What is being tested?
- auricular needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100029
About this study
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.
Read the detailed 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.
- Conditions
- Anorexia Nervosa, Cancer
- Being tested
- auricular needling
- Keywords
- Auricular Needling, Mechanism Study, Anorexia, Cancer
- Medical subject headings
- Anorexia Nervosa, Neoplasms, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Needling group | Experimental | Patients will receive auricular needling for 4 weeks . Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (3)
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"
Measured: 10 weeks
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.
Measured: 10 weeks
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).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin He, Principal investigator, Xiyuan Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887586
- Sponsor's protocol ID
- 81573958
- Status last verified
- Dec 2017
- First submitted
- 16 Aug 2016
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
- ClinicalTrials.gov ID
- NCT02887586
- Acronym / sponsor ID
- 81573958
- Conditions
- Anorexia Nervosa, Cancer
- Keywords
- Auricular Needling, Mechanism Study, Anorexia, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Needling group | Experimental | Other: auricular needlingPatients will receive auricular needling for 4 weeks . |
| control group | No intervention | –This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular needlingPatients 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. | Other | Auricular Needling group |
Primary outcome
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.
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.
3 secondary outcomes
Appetite Improvement
Time frame: 10 weeks
Weight
Time frame: 10 weeks
Acupuncture Treating Expectation Questionnaire
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin He principal investigator
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular needling in people with Anorexia Nervosa and Cancer, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simple Appetite Questionnaire (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.