Condition or disease | Intervention/treatment | Phase |
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Cachexia Malignant Solid Neoplasm | Procedure: Physical Therapy Other: Questionnaire Administration Procedure: Ultrasound | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Feasibility Study of Ultrasound to Evaluate Muscle-Glycogen Content in Patients With Cancer |
Actual Study Start Date : | April 12, 2019 |
Estimated Primary Completion Date : | December 31, 2019 |
Estimated Study Completion Date : | December 31, 2019 |
Arm | Intervention/treatment |
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Experimental: Device feasibility (MuscleSound technology)
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.
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Procedure: Physical Therapy
Undergo physical therapy
Other Names:
Other: Questionnaire Administration Ancillary studies
Procedure: Ultrasound Undergo ultrasound via MuscleSound technology
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with a biopsy-confirmed solid malignant neoplasm with at least one neurologically-intact lower extremity, who fit into one of the following groups:
Exclusion Criteria:
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Ying Guo | M.D. Anderson Cancer Center |
Tracking Information | |||||
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First Submitted Date ICMJE | April 23, 2019 | ||||
First Posted Date ICMJE | June 11, 2019 | ||||
Last Update Posted Date | July 23, 2019 | ||||
Actual Study Start Date ICMJE | April 12, 2019 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Glycogen Storage Assessment [ 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)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients | ||||
Official Title ICMJE | Feasibility Study of Ultrasound to Evaluate Muscle-Glycogen Content in Patients With Cancer | ||||
Brief Summary | 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. | ||||
Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Device Feasibility |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Device feasibility (MuscleSound technology)
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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
21 | ||||
Original Estimated Enrollment ICMJE |
30 | ||||
Estimated Study Completion Date ICMJE | December 31, 2019 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03982082 | ||||
Other Study ID Numbers ICMJE | 2018-1180 NCI-2019-02281 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-1180 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |