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Completed

NCT Number: NCT03982082

Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

physical therapy

Procedure

Undergo physical therapy

Other names: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Questionnaire Administration

Other

Ancillary studies

Ultrasound

Procedure

Undergo ultrasound via MuscleSound technology

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jun 11, 2019
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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