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Exercise training has beneficial effects in cancer survivors to minimize some of the side effects of cancer and its treatment and improve long-term prognosis, but there are numerous hurdles for individuals diagnosed with, and being treated for, cancer to participate in exercise programs. The goal of this research study is to begin to evaluate whether exercise training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal muscle size and function in cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMES | Experimental | Neuromuscular electrical stimulation (NMES) group |
|
| Control | No Intervention | Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation | Device | Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Calcium-activated Tension Single Muscle Fiber Tension | Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis | Difference between values at baseline at 2 months |
| Cross-sectional Area of Skeletal Muscle Fibers | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | Difference between values at baseline at 2 months |
| Intermyofibrillar Mitochondrial Content | Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy | Difference between values at baseline at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Single Muscle Fiber Contractile Velocity | Single muscle fiber contractile velocity assessed using isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis. The velocity of contraction is expressed relative to the length of the muscle fiber segment evaluated (as measured using a eyepiece micrometer during assessments) per second. | Difference between values at baseline at 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Toth, PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont College of Medicine | Burlington | Vermont | 05405 | United States |
Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | NMES | Neuromuscular electrical stimulation (NMES) group Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months. |
| FG001 | Control | Control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NMES | Neuromuscular electrical stimulation (NMES) group Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Calcium-activated Tension Single Muscle Fiber Tension | Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis | The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing. | Posted | Mean | Standard Error | milliNewtons per millimeter^2 | Difference between values at baseline at 2 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NMES | Neuromuscular electrical stimulation (NMES) group Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Infections and infestations | Systematic Assessment | Hospitalization for pyelonephritis. Adjudicated to be severe, unexpected and not related to study participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile episode | Infections and infestations | Systematic Assessment | Patient became febrile during testing. Adjudicated to be moderate severity, unexpected and not related to study participation/intevention. |
Our study was powered to detect effects on skeletal muscle at the cellular level over a short time period during treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J. Toth | University of Vermont | 802-656-7989 | michael.toth@med.uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2019 | Feb 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Control group
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Percentage of body fat | Mean | Standard Deviation | percent |
|
| Fat mass | Mean | Standard Deviation | kilograms |
|
| Fat-free mass | Mean | Standard Deviation | kilograms |
|
| Appendicular skeletal muscle mass | Mean | Standard Deviation | kilograms |
|
| Control |
Control group |
|
|
| Primary | Cross-sectional Area of Skeletal Muscle Fibers | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing. | Posted | Mean | Standard Error | micrometers^2 | Difference between values at baseline at 2 months |
|
|
|
| Primary | Intermyofibrillar Mitochondrial Content | Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy | The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing and the fact that electron microscopy measures could not be completed on one volunteer because of insufficient muscle tissue. | Posted | Mean | Standard Error | percentage of image area | Difference between values at baseline at 2 months |
|
|
|
| Secondary | Single Muscle Fiber Contractile Velocity | Single muscle fiber contractile velocity assessed using isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis. The velocity of contraction is expressed relative to the length of the muscle fiber segment evaluated (as measured using a eyepiece micrometer during assessments) per second. | The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing. | Posted | Mean | Standard Error | muscle lengths per second | Difference between values at baseline at 2 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control | Control group | 0 | 10 | 1 | 10 | 1 | 10 |
|
|
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| D017437 |
| Skin and Connective Tissue Diseases |