Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

NCT03982082 | Completed

• 2 other identifiers: 2018-1180NCI-2019-02281
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cachexia; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional Independent Measure

  At baseline

• Cancer characteristics of the patient

  At baseline within 30 minutes of consent

• Patient reported outcomes

  At baseline

Study Arms (1)

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.

Procedure: Physical Therapy; Other: Questionnaire Administration; Procedure: Ultrasound

Interventions

Physical Therapy PROCEDURE

Undergo physical therapy

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Device feasibility (MuscleSound technology)

Questionnaire Administration OTHER

Ancillary studies

Device feasibility (MuscleSound technology)

Ultrasound PROCEDURE

Undergo ultrasound via MuscleSound technology

Device feasibility (MuscleSound technology)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Cachexia

Interventions

Physical Therapy Modalities; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Ying Guo, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: June 11, 2019
• Study Start: April 12, 2019
• Primary Completion: January 13, 2024
• Study Completion: January 13, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

US (1)