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| ID | Type | Description | Link |
|---|---|---|---|
| 2015CB554504 | Other Grant/Funding Number | National Program on Key Basic Research Project (973 Program) |
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| Name | Class |
|---|---|
| Chengdu University of Traditional Chinese Medicine | OTHER |
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This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.
Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture+Placebo | Experimental | Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days. |
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| Megestrol Acetate+Sham acupuncture | Active Comparator | Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days . |
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| Placebo+Sham acupuncture | Placebo Comparator | Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appetite Visual Analog Scale | The assessment will be done thirty minutes before meals. The participators should record the score of their appetite (0 to 100 mm) the higher scores reflect better symptom control. | Baseline, the days 8 and 15. |
| Measure | Description | Time Frame |
|---|---|---|
| Council of Nutrition appetite questionnaire (CNAQ) | Ask the subjects to complete the questionnaire by circling the correct answers and then tally the results based upon the following numerical scale: a =1, b = 2, c = 3, d = 4, e = 5. The sum of the scores for the individual items constitutes the CNAQ score. CNAQ score ≤28 indicates significant risk of at least 5% weight loss within six months. | Baseline, the days 8 and 15. |
| Measure | Description | Time Frame |
|---|---|---|
| Edmonton Symptom Assessment Scale | Edmonton Symptom Assessment Scale is a nine-item patient-rated symptom visual analogue scale developed for use in assessing the symptoms of patients receiving palliative care. | Baseline, the days 8 and 15. |
| The Questionnaire of Acupuncture-related Events(QAE) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zihui Xu, PhD | Contact | 86-023-68755615 | zihuixu@yeah.net | |
| Ye Cui, MD | Contact | 86-023-68774249 | cuiyendian@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong Tang, PhD | Chengdu University of Traditional Chinese Medicine | Study Chair |
| Chaoting Zhao, MD | Xinqiao Hospital | Study Director |
| Haiou Luo, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing TCM Hospital | Not yet recruiting | Jiangbei | Chongqing Municipality | 402760 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23439759 | Background | Del Fabbro E, Dev R, Hui D, Palmer L, Bruera E. Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: a double-blind placebo-controlled trial. J Clin Oncol. 2013 Apr 1;31(10):1271-6. doi: 10.1200/JCO.2012.43.6766. Epub 2013 Feb 25. | |
| 12506181 | Background | Bruera E, Strasser F, Palmer JL, Willey J, Calder K, Amyotte G, Baracos V. Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: a double-blind, placebo-controlled study. J Clin Oncol. 2003 Jan 1;21(1):129-34. doi: 10.1200/JCO.2003.01.101. |
| Label | URL |
|---|---|
| Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer | View source |
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| Sham Acupuncture | Other | Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders. |
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| Megestrol Acetate | Drug | Megestrol Acetate 160mg tablet |
|
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| Placebo(Megestrol Acetate) | Drug | Starch pill manufactured to mimic Megestrol Acetate 160mg tablet |
|
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| Caloric intake | The caloric intake will be assessed by the dietician. | Baseline, the days 8 and 15. |
| Functional Assessment of Anorexia/Cachexia Therapy | Functional Assessment of Anorexia/Cachexia Therapy was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns. | Baseline, the days 8 and 15. |
| Nutritional status | weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined | Baseline, the days 8 and 15. |
The side effects and their detail will be record during and after the acupuncture. |
| Baseline and the days 7 |
| Xinqiao Hospital |
| Principal Investigator |
| XinQiao Hosiptal | Recruiting | Shapingba | Chongqing Municipality | 400037 | China |
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| Donghua Hosiptal | Not yet recruiting | Shapingba | Chongqing Municipality | China |
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| Daping Hospital | Recruiting | Yuzhong | Chongqing Municipality | 400042 | China |
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| 2205358 | Background | Bruera E, Macmillan K, Kuehn N, Hanson J, MacDonald RN. A controlled trial of megestrol acetate on appetite, caloric intake, nutritional status, and other symptoms in patients with advanced cancer. Cancer. 1990 Sep 15;66(6):1279-82. doi: 10.1002/1097-0142(19900915)66:63.0.co;2-r. |
| ID | Term |
|---|---|
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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