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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular Needling group | Experimental | Patients 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin He | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100029 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Auricular Needling Group | Patients will receive auricular needling for 4 weeks . 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 Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner. |
| FG001 | Control Group | This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Fall off in 5 cases, fall off reason : active request exit in 1 case, disease progression can not complete treatment in 1 case, 3 cases of loss rate 8.3 %.
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| ID | Title | Description |
|---|---|---|
| BG000 | Auricular Needling Group | Patients will receive auricular needling for 4 weeks . 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 Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The mean age of these 55 participants was 65±11 (range, 31 to 80) years old. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
ten weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auricular Needling Group | Patients will receive auricular needling for 4 weeks . 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 Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hebin | Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences | 13520253895 | hebinbj68@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2016 | Jan 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2016 | Jan 24, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2016 | Feb 17, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D009369 | Neoplasms |
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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|
| 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. | 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). | 10 weeks |
| BG001 | Control Group | This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | The mean age of these 55 participants was 65±11 (range, 31 to 80) years old. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 15 males and 13 females in control group and 10 males and 17 females in ear acupuncture group . | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All participants are from China. | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
| OG001 | Control Group | This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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" | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | kg | 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). | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control Group | This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Treatment for 4 weeks |
|
| Stop treatment for 4 weeks |
|
| Treatment for 4 weeks |
|
| Stop treatment for 4 weeks |
|
| Treatment for 4 weeks |
|
| Stop treatment for 4 weeks |
|
| Treatment for 4 weeks |
|
| Stop treatment for 4 weeks |
|