Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

Feasibility Study of Ultrasound to Evaluate Muscle-Glycogen Content in Patients With Cancer

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.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; Cachexia
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Physical Therapy; Procedure: Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Physical Therapy; Undergo physical therapy; Other Names: PT; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; Procedure: Ultrasound; Undergo ultrasound via MuscleSound technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ying Guo, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2019
• Primary Completion (Actual): January 13, 2024
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Thinness; Cachexia; Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: 2018-1180 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02281 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No