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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02281 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-1180 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device feasibility (MuscleSound technology) | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Procedure | Undergo physical therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Glycogen Storage Assessment | Muscle-glycogen status will be assessed using ultrasound and MuscleSound® technology which generates an average FRS (Fuel Rating Score) | Within 30 minutes of consent |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Independent Measure | 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. | At baseline |
Inclusion Criteria:
Participants are willing and able to give written informed consent and to comply with study procedures.
Patients with a biopsy-confirmed solid malignant neoplasm with at least one neurologically-intact lower extremity, who fit into one of the following groups:
Patients who have a record of weight or BMI over preceding 6-months.
Patients must be receiving rehabilitation that includes exercise under the direction of a physical therapist.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Guo, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2019 | Oct 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
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| Questionnaire Administration | Other | Ancillary studies |
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| Ultrasound | Procedure | Undergo ultrasound via MuscleSound technology |
|
| Cancer characteristics of the patient |
Type of cancer, stage of cancer; past and present treatment |
| At baseline within 30 minutes of consent |
| Patient reported outcomes | Patient-Generated Subjective Global Assessment (PG SGA-SF) Patient Reported Outcomes is a tool used to measure risks for malnutrition. | At baseline |
| Patient reported outcomes | 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. | At baseline |
| Body Composition | Will be accessed using the bioimpedance machine to measure body fat and muscle mass. | At baseline |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D011840 |
| Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |