Ultrasound for Evaluating Muscle Health in Cancer Patients

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-English, Neurological compromise, Unstable condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well an ultrasound procedure, using MuscleSound technology, assesses muscle energy storage in cancer patients undergoing rehabilitation. It examines glycogen levels in muscles to understand their relationship with energy storage and exercise tolerance. This research could lead to better dietary plans to improve energy and physical function. Participants include cancer patients in rehab who have experienced weight loss due to cachexia (severe weight loss and muscle wasting) or those without it, provided they can exercise under a physical therapist's guidance. As an unphased trial, this study allows patients to contribute to innovative research that could enhance rehabilitation strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound procedure is safe for evaluating muscle health in cancer patients?

Research shows that ultrasound, a tool often used for imaging, is very safe when trained professionals use it. Patients generally tolerate it well. Studies have found that ultrasound can effectively check muscle health in cancer patients without causing harm. However, very high levels of ultrasound can potentially damage tissues. In this trial, researchers use ultrasound safely and at low levels to examine muscle energy storage in cancer patients. Similar studies have not linked this method to any significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ultrasound for evaluating muscle health in cancer patients is unique because it offers a non-invasive and quick way to assess muscle condition. Traditional methods like biopsies or imaging techniques often require more time, are invasive, or involve radiation exposure. This ultrasound approach, using MuscleSound technology, only takes a few minutes and can be performed alongside regular physical therapy sessions. Researchers are excited because it could allow for real-time monitoring of muscle health, helping to tailor treatment plans more effectively for cancer patients.

What evidence suggests that this ultrasound procedure is effective for evaluating muscle health in cancer patients?

Research shows that ultrasound is a useful tool for checking muscle health in cancer patients. Studies have found that it helps assess muscle size and condition, which are important for understanding a patient's overall health. For cancer patients, maintaining muscle mass links to a better quality of life and improved outcomes. Another study found that ultrasound can also predict nutritional health and the risk of malnutrition in these patients. In this trial, participants will undergo ultrasound using MuscleSound technology, providing a non-invasive way to monitor muscle health and assist in planning future care. ^{3 6 7 8 9}

Who Is on the Research Team?

Ying Guo, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer patients with or without cachexia, which involves significant weight loss. Participants must be able to consent and follow study procedures, have a record of their weight or BMI from the past 6 months, and be undergoing physical therapy-led rehabilitation. Excluded are those unable to understand instructions, non-English speakers, patients with unstable medical conditions that limit exercise participation, or those with neurological issues causing muscle atrophy in both lower extremities.

Inclusion Criteria

My weight or BMI has been recorded in the last 6 months.

I have a confirmed solid tumor and can move at least one of my legs.

I have lost more than 5% of my weight in the last 6 months without trying, or I've lost over 2% with a BMI under 20.

Exclusion Criteria

I can understand and follow the study's instructions.

I don't have any health conditions that stop me from doing leg exercises.

I have muscle loss in both legs due to nerve damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Baseline glycogen storage and other baseline measures are assessed using ultrasound and other tools

1 day

1 visit (in-person)

Treatment

Participants undergo ultrasound via MuscleSound technology and physical therapy sessions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound

Trial Overview The trial is testing how well ultrasound technology (MuscleSound) can measure muscle glycogen levels in cancer patients during rehab. The goal is to use this data for future research on dietary plans and exercises that could improve energy storage in muscles and enhance patient recovery.

How Is the Trial Designed?

Group I: Device feasibility (MuscleSound technology) Experimental Treatment 3 Interventions

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 Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354854/

Muscle thickness from amplitude mode ultrasound and clinical ... This study investigated the association between A-mode ultrasound -derived muscle thickness and adverse outcomes, including mortality, prolonged ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0899900725000814

Association between muscle mass assessed by an artificial ... Emerging evidence suggests that diminished skeletal muscle mass is associated with lower health-related quality of life (HRQOL) in individuals with cancer.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35851996/

The current use of ultrasound to measure skeletal muscle ... This review aims to describe the current use of skeletal muscle ultrasound (SMUS) to measure muscle mass and quality in patients with acute and chronic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325001040

Review Article Ultrasound for skeletal muscle assessment ... This review demonstrated the validity and the applications of ultrasound for skeletal muscle assessment in cancer patients during the perioperative period.

5. mdpi.com mdpi.com/2072-6643/16/3/387

Ultrasound Muscle Evaluation for Predicting the Prognosis ... This study aimed to evaluate the use of ultrasound techniques for predicting nutritional status, malnutrition, and cancer outcomes in patients with HNC. A total ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8954895/

Possible Effects on Health of Ultrasound Exposure, Risk ... The Health Protection Agency (HPA) [6] states that high levels of exposure to ultrasound can produce permanent damage to biological tissues.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11796337/

Overview of Therapeutic Ultrasound Applications and Safety ... Ultrasound is known commonly as a diagnostic imaging modality that has an excellent safety record when used as intended by a qualified sonographer. Although the ...

8. nature.com nature.com/articles/s41598-025-15995-6

Muscle thickness from amplitude mode ultrasound and ... The reduction of skeletal muscle mass in catabolic conditions, such as cancer, is linked to adverse outcomes. Assessing muscle health ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/01635581.2025.2512611?af=R

Ultrasound Measurements of Skeletal Muscle Predict ... This study investigates the relationship between muscle ultrasound measurements and chemotherapy toxicity in NSCLC patients, as well as the ability of these ...