M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT03982082
This trial studies how well an ultrasound procedure (non-invasive MuscleSound technology) can be used to learn about levels of glycogen (a type of sugar) in cancer patients during inpatient rehabilitation. The ultrasound information will be processed to represent the energy storage in the muscle. The energy storage in the muscle may help future research to look for dietary plans that can help to increase energy storage, patient exercise tolerance, and functional improvement.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
PRIMARY OBJECTIVES:
I. Determine feasibility of using non-invasive MuscleSound technology to determine glycogen stores in cancer patients.
EXPLORATORY OBJECTIVES:
I. Determine the baseline glycogen storage in two different groups of cancer patients, who are undergoing inpatient rehabilitation: (1) those with cachexia; (2) those without cachexia.
II. Determine the rate of depletion of muscle-glycogen stores by calculating the "Fuel Rating" score (FRS) at baseline, after 10-min of exercise and then again after 20-min of exercise.
III. Determine if there is any correlation between muscle-glycogen (at baseline and its depletion rate over time) and other factors including cancer type, cancer stage, patient age, patient sex, current body mass index (BMI), presence or absence of cachexia, functional measures and patient reported outcomes.
OUTLINE:
Patients undergo ultrasound via MuscleSound technology over 3 minutes at baseline and immediately after each of 2 physical therapy sessions comprising cycling or walking over 10 minutes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo physical therapy
Other names: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT
Ancillary studies
Undergo ultrasound via MuscleSound technology
Time frame: Within 30 minutes of consent
Muscle-glycogen status will be assessed using ultrasound and MuscleSound® technology which generates an average FRS (Fuel Rating Score)
Time frame: At baseline
The FIM (Functional Independent Measure) score will be collected retrospectively from the patient's medical record as this is performed by a nurse or therapist. This measure provides a measurement for assessing how much assistance is required for the patient to complete activities of daily living.
Time frame: At baseline within 30 minutes of consent
Type of cancer, stage of cancer; past and present treatment
Time frame: At baseline
Patient-Generated Subjective Global Assessment (PG SGA-SF) Patient Reported Outcomes is a tool used to measure risks for malnutrition.
Time frame: At baseline
Edmonton Symptom Assessment Scale (ESAS) is a validated tool for regular assessment of symptom distress in the Rehabilitation setting. Patients are asked to grade severity of their symptoms from "no symptom" 0 to "worst symptom" 10 in the last 24 hours. ESAS has high test-retest reliability of (>0.8) and has been validated in many clinical settings including cancer patients.
Time frame: At baseline
Will be accessed using the bioimpedance machine to measure body fat and muscle mass.
M.D. Anderson Cancer Center
Other
Feasibility Study of Ultrasound to Evaluate Muscle-Glycogen Content in Patients With Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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