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Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

Primary Purpose

Cachexia, Malignant Solid Neoplasm

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Therapy

Questionnaire Administration

Ultrasound

About this trial

This is an interventional device feasibility trial for Cachexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device feasibility (MuscleSound technology)

Arm Description

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.

Outcomes

Primary Outcome Measures

Glycogen Storage Assessment

Muscle-glycogen status will be assessed using ultrasound and MuscleSound® technology which generates an average FRS (Fuel Rating Score)

Secondary Outcome Measures

Full Information

NCT ID

NCT03982082

First Posted

April 23, 2019

Last Updated

October 2, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03982082

Brief Title

Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 12, 2019 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cachexia, Malignant Solid Neoplasm

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device feasibility (MuscleSound technology)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Physical Therapy

Other Intervention Name(s)

Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Intervention Description

Undergo physical therapy

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Procedure

Intervention Name(s)

Ultrasound

Intervention Description

Undergo ultrasound via MuscleSound technology

Primary Outcome Measure Information:

Title

Glycogen Storage Assessment

Description

Muscle-glycogen status will be assessed using ultrasound and MuscleSound® technology which generates an average FRS (Fuel Rating Score)

Time Frame

Within 30 minutes of consent

Other Pre-specified Outcome Measures:

Title

Functional Independent Measure

Description

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.

Time Frame

At baseline

Title

Cancer characteristics of the patient

Description

Type of cancer, stage of cancer; past and present treatment

Time Frame

At baseline within 30 minutes of consent

Title

Patient reported outcomes

Description

Patient-Generated Subjective Global Assessment (PG SGA-SF) Patient Reported Outcomes is a tool used to measure risks for malnutrition.

Time Frame

At baseline

Title

Patient reported outcomes

Description

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.

Time Frame

At baseline

Title

Body Composition

Description

Will be accessed using the bioimpedance machine to measure body fat and muscle mass.

Time Frame

At baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ying Guo, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

MD Anderson Cancer Center

Learn more about this trial

Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

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