A Phase 1 interventional study of Remune and EXCAP©® in Cachexia; Cancer, Weight Loss and Lung Cancer, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-15.
Sponsored by University of Rochester · Phase 1, Interventional, and Supportive care
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
A nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist
Drug: Remune
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
Drug: Remune · Other: EXCAP©®
Usual standard care as prescribed by your oncologist
Remune is intended for the dietary management of disease related malnutrition especially in patients with precachexia or cachexia due to cancer or COPD
EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises
Also known as: Exercise for Cancer Patients
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measured by adverse event severity and quantity
Time frame: 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
Time frame: 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%
Time frame: 3 months
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 3 months
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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