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| ID | Type | Description | Link |
|---|---|---|---|
| OCR14647 | Other Identifier | University of Florida |
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Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. An intervention with acupuncture may slow down or stop the progression of cancer-related anorexia and weight loss.
The purpose of this research study is to investigate if acupuncture helps to improve appetite and slow down unintentional weight loss. The participants will be randomly divided into two groups and receive 8 sessions of acupuncture (two groups will receive different acupuncture points) for 8 weeks. During the study period, participants will be asked various questions about appetite, physical functioning, cancer-related symptoms and quality of life to understand changes related to body weight, as well as blood samples. The research team members will collect data regarding changes in appetite, body weight, body composition, and physical functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cachexia Acupuncture-A | Experimental | Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points that are selected based on the potential mechanisms of cachexia. Intervention will be done by a licensed acupuncturist who has over 5 years of experience as an independent clinician and has experience particularly in the management of cancer related symptoms. Acupuncture treatment will consist of 8 sessions over 8 week period. Acupuncture needles: Single-use, sterile stainless steel and disposable [acupuncture needles-Peace Classic Needles®, Acu-Market] Other name: Mechanism based acupuncture |
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| General Acupuncture-B | Sham Comparator | General Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points. These points are the real acupuncture points; however, these points are not specific to cachexia management. Participants will receive the acupuncture treatment over 8 weeks (total of 8 sessions) in the same manner as the experimental group; the only difference will be the place(type) and number of points targeted. Acupuncture needles: single-use, sterile stainless steel and disposable needles [Peace Classic Needles®, Acu-Market] Other name: General acupuncture |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cachexia Acupuncture-A (Peace Classic Needles® ) | Device | Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage weight change over 8 weeks between two arms | Weight will be measured each visit (pounds). | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite change between two arms | Three different short survey forms will be used to measure appetite change. Visual analogue scale (0 indicates no appetite and 10 is the best appetite). Simplified Nutritional Appetite Questionnaire score (min-max: 4-20 and the higher the better appetite) Patient Generated Subjective Global Assessment: 0-1, no intervention is needed. 9 or higher score indicates critical intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life between two arms | Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much") . | up to 8 weeks |
| biomarkers | Small amounts of blood will be drawn. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saunjoo Yoon, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Clinical Research Center (CRC) | Gainesville | Florida | 32610-0219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29971962 | Derived | Yoon SL, Grundmann O, Williams JJ, Gordan L, George TJ Jr. Body composition changes differ by gender in stomach, colorectal, and biliary cancer patients with cachexia: Results from a pilot study. Cancer Med. 2018 Aug;7(8):3695-3703. doi: 10.1002/cam4.1665. Epub 2018 Jul 3. |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D000855 | Anorexia |
| D002100 | Cachexia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| General Acupuncture-B (Peace Classic Needles®) | Device | Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points. |
|
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| up to 8 weeks |
| physical functioning | survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning). | up to 8 weeks |
| body composition | Small, non-invasive device (bioelectrical impedance analysis) like a miniature version of EKG will measure changes in body composition (numeric scale). | up to 8 weeks |
| weeks 1, 4 and 8 (three measurements) |
| symptom experience | Survey format: 13 areas related to the symptom experience and patient's concerns will be assessed (4 points scale; 0 means 'not at all' and 3 means 'very much'). | up to 8 weeks |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D013851 | Thinness |