Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03982082
• Other study ID #: 2018-1180
• Secondary ID: NCI-2019-0228120
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Malignant Solid Neoplasm

Intervention

Procedure:
• Physical Therapy
Undergo physical therapy

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Ultrasound
Undergo ultrasound via MuscleSound technology

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Cancer characteristics of the patient	Type of cancer, stage of cancer; past and present treatment	At baseline within 30 minutes of consent
Other	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
Other	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
Other	Body Composition	Will be accessed using the bioimpedance machine to measure body fat and muscle mass.	At baseline
Primary	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

External Links

•   MD Anderson Cancer Center