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Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

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ClinicalTrials.gov Identifier: NCT03982082
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Cachexia Malignant Solid Neoplasm Procedure: Physical Therapy Other: Questionnaire Administration Procedure: Ultrasound Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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.
Procedure: Physical Therapy
Undergo physical therapy
Other Names:
  • Physiatric Procedure
  • Physical Medicine Procedure
  • Physical Therapeutics
  • Physical Therapy Procedure
  • Physiotherapy
  • Physiotherapy Procedure
  • PT

Other: Questionnaire Administration
Ancillary studies

Procedure: Ultrasound
Undergo ultrasound via MuscleSound technology




Primary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. Functional Independent Measure [ 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.

  2. Cancer characteristics of the patient [ Time Frame: At baseline within 30 minutes of consent ]
    Type of cancer, stage of cancer; past and present treatment

  3. Patient reported outcomes [ Time Frame: At baseline ]
    Patient-Generated Subjective Global Assessment (PG SGA-SF) Patient Reported Outcomes is a tool used to measure risks for malnutrition.

  4. Patient reported outcomes [ 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.

  5. Body Composition [ Time Frame: At baseline ]
    Will be accessed using the bioimpedance machine to measure body fat and muscle mass.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    • Group 1: Patients with cachexia, defined by loss of > 5% of body weight over the preceding 6-months (in absence of simple starvation defined as intentional weight loss) or weight loss > 2% with BMI < 20.
    • Group 2: Patients without cachexia, as defined above.
  • 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:

  • Non-English speaking patients.
  • Patient with neurological compromise of both lower extremities causing muscle atrophy.
  • Underlying unstable medical condition (i.e: cardiac, pulmonary, or hematological) or musculoskeletal injury, which in the opinion of the investigator, limits participation in exercise of the measured lower extremity.
  • Patients who are unable to understand or follow through with study instructions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982082


Contacts
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Contact: Ying Guo 713-792-6082 yguo@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ying Guo    713-792-6082      
Principal Investigator: Ying Guo         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ying Guo M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03982082     History of Changes
Other Study ID Numbers: 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 )
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cachexia
Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms