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| Name | Class |
|---|---|
| Smartfish AS | INDUSTRY |
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The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.
In this study the investigator would like to better understand how cachexia may improve or worsen, and how exercise and nutritional supplements may impact this process. The investigator would like to see whether a nutritional supplement (Remune) with or without a walking and progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with lung or gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this nutritional supplement and exercise intervention improves physical performance, day-to-day function, quality of life, and how the supplement and/or exercise may affect different markers in the blood over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remune dosed twice daily | Experimental | A nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist |
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| Remune dosed twice daily and daily exercise with EXCAP | Experimental | A nutritional supplement taken twice by day each day and a home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist |
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| Usual Care | No Intervention | Usual standard care as prescribed by your oncologist |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remune | Drug | Remune is intended for the dietary management of disease related malnutrition especially in patients with precachexia or cachexia due to cancer or COPD |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | measured by adverse event severity and quantity | 3 months |
| Adherance | Did 70% of subjects in the supplement arm consume 60% of supplement evening. Patients are asked to report the number of cartons of Remune consumed each day and how much they consumed | 3 months |
| Recruitment and Retention | Recruitment of 45 patients (15 per arm) and at least 10 evaluable patients in each arm for retention rate of 66% | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects that improve physical function- Walking | 6 minute walk test distance; Participants are given a short warm up and cool down walking protocol in the test walking area in the University. During the 6-minute walk, participants will be asked to wear a sensor that will measure movement ability. The sensor is secured by an ergonomic belt around the participant's waist and allows for free body movement and comfort. Participants walk for a total of 6 minutes and cover as much distance as they can during this time. Upon completion of the test, the total distance walked is used to measure physical performance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Dunne | University of Rochester Wilmot Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| EXCAP©® | Other | EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises |
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| 3 months |
| Proportion of subjects that improve physical function- Power | Power will be assessed by the Stair Climb Performance Test (SCPT) which is performed by having subjects safely ascend a flight of stairs (approximately 10 stairs total) as quick and as safely as possible with supervision. The subject can use the handrail as a safety precaution if deemed necessary by the patient, physician, coordinator, or exercise physiologist. Power is calculated by force (calculated by body mass and acceleration due to gravity) multiplied by the velocity (distance/time). | 3 months |
| Proportion of subjects that improve physical function- Muscle Strength | Muscular strength will be assessed objectively using The Handgrip Dynamometer Test. The Handgrip Dynamometer Test is a grip strength test used to assess the maximal voluntary contraction generated by the arm muscles. The test is administered with the patient standing with the elbow joint angle held constant at 180 degrees and the medial distal humeral epicondyle held 2 inches from the torso. Trials will be performed in an alternating bilateral sequence, for a total of six attempts (three with each arm). The best score of the three hand-grip trials will be used for right and left limbs to calculate static strength. | 3 months |
| Porportion of subjects with improved cachexia-related symptoms 3 months | The Functional Assessment of Anoreix/Cachexia Therapy subscale is a 39-item questionnaire that measures general aspects of quality of life as well as specific anorexia/cachexia-related concerns. This will be collected at pre- and post intervention. | 3 months |
| ID | Term |
|---|---|
| D002100 | Cachexia |
| D009369 | Neoplasms |
| D015431 | Weight Loss |
| D008175 | Lung Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C105086 | remune |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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