Atlanta, Georgia 30322

  • Cancer

Purpose:

This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following Resistance Training (RT) and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.


Study summary:

Interventions that reduce pro-inflammatory cytokines with resultant stimulation of kynurenine metabolism may be increasingly important in Breast Cancer Survivors (BCS) to prevent susceptibility to cancer associated fatigue, depression, and declines in muscle mass and function. There is emerging evidence that supports exercise as a non-pharmacological therapy to prevent cancer recurrence, sedentary behaviors, and obesity during cancer survivorship . It seems that interventions that include resistance training (RT) are most efficacious at reducing fatigue in BCS This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following RT and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.


Criteria:

Inclusion Criteria: 1. within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer, 2. at least 6 months post breast reconstruction (if applicable), 3. lack of menses for at least one year, 4. BMI 20-35 kg/m2, 5. fatigued (subjective reporting ≥3 on a 1-10 scale), 6. untrained with regard to structured resistance training (no more than 3x/week). Exclusion Criteria: 1. plans for surgery (e.g., breast reconstruction) during the study period, 2. taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban), 3. allergic to lidocaine, 4. orthopedic or chronic pain condition restricting exercise, 5. Mini-Mental Status Examination (MMSE) scores below education-specific cut-points (less than 23 for more than 9th grade education and less than 17 for less than 8th grade education), 6. unable to receive physician medical clearance.


Study is Available At:


Original ID:

IRB00103558


NCT ID:

NCT03539835


Secondary ID:


Study Acronym:


Brief Title:

Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors


Official Title:

Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

50 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Emory University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Monica Serra, MD
Principal Investigator
Emory University

Study Dates

Start Date:December 10, 2018
Completion Date:March 12, 2020
Completion Type:Actual
Primary Completion Date:March 9, 2020
Primary Completion Type:Actual
Verification Date:July 2020
Last Changed Date:July 24, 2020
First Received Date:May 16, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each scale contai
Outcome Type:Secondary Outcome
Measure:Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Outcome Type:Secondary Outcome
Measure:Change in balance test score
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Berg Balance Scale is an observer rated scale developed to rate fall risk that consists of 14 items (0-4 point scale) of mobility related to balance.
Outcome Type:Secondary Outcome
Measure:Change in muscle function assessed by Isometric Handgrip test.
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Hand grip strength of both arms will be assessed using a handheld dynamometer. The subjects will be tested while seated with the shoulders adducted, the elbow flexed to 90 degrees, and the forearm in a neutral position. The subjects will be instructed to
Outcome Type:Secondary Outcome
Measure:Change in muscle function assessed by Lower Extremity Endurance test
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:The subjects will be asked to perform the leg press and leg extension exercises at 60% of maximum strength as many times as they can before fatigue, paced by a metronome set to 30. Endurance in the right and left legs will be tested separately using equip
Outcome Type:Secondary Outcome
Measure:Change in muscle function assessed by Lower Extremity Strength test
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Standardized strength assessment protocol that includes 4-6 trials with rest periods of the leg extension, leg press, and chest press exercises will be used. Strength in the right and left legs will be tested separately.
Outcome Type:Secondary Outcome
Measure:Change in Timed Up and Go (TUG) completion time
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Subjects are observed and timed while they rise from a chair, walk 3 meters, turn around, walk back, and sit down. The total time to complete this task will be recorded.
Outcome Type:Secondary Outcome
Measure:Change in 30 meter walk velocity
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Self-selected and fastest-comfortable floor walking velocity will be determined from 30 meter walks with subjects using the same assistive device and/or orthosis as normally used to "walk across the room at home."
Outcome Type:Secondary Outcome
Measure:Change in Functional Gait Assessment score
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Subjects will be asked to perform various tasks to assess functional gait including stepping onto a small stool, doing a turn, and picking a small object off the floor. Participants will be scored on their ability to perform each task without difficulty.
Outcome Type:Secondary Outcome
Measure:Change in 6 min walk distance
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Subjects will use the same assistive device typically used and will be instructed to cover as much distance as they can in six minutes over a flat walking surface.
Outcome Type:Secondary Outcome
Measure:Change in Resting Metabolic Rate (RMR)
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:RMR will be measured using the ventilated hood technique while subjects lie quietly in bed for 30-45 mins under a clear plastic hood with expired air collected through a one-way valve. RMR will be measured at rest under fasting conditions. It will be repo
Outcome Type:Secondary Outcome
Measure:Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) level
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) is a key transcription coactivator regulating energy metabolism in a tissue-specific manner. PGC-1α level will be measured by enzyme-linked immunosorbent assay in blood sample.
Outcome Type:Secondary Outcome
Measure:Change in kynurenic acid level
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:Kynurenic acid is a product of the normal metabolism of amino acid L-tryptophan. It has been shown that kynurenic acid possesses neuroactive activity. Kynurenic acid level will be measured by enzyme-linked immunosorbent assay in blood sample. .
Outcome Type:Secondary Outcome
Measure:Change in interleukin-6 (IL-6) level
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:IL-6 is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory marker in skeletal muscle. IL-6 level will be measured by enzyme-linked immunosorbent assay in blood sample.
Outcome Type:Secondary Outcome
Measure:Change in tumor necrosis factor-α (TNF-α) protein level
Time Frame:Baseline, 12 weeks follow up
Safety Issues:False
Description:tumor necrosis factor-α (TNF-α) is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction.TNF-α protein level will be measured by enzyme-linked immunosorbent assay in blood s

Study Interventions

Intervention Type:Behavioral
Name:Cognitively-based compassion training control (CBC
Description:Cognitively-based compassion training control (CBCT) classes will be performed in a group setting for 1.5-2 hours per week, and consist of didactics, class discussion, and guided meditation practice. Each class will begin with a period of meditation to calm and focus the mind, followed by analytical practices designed to challenge unexamined assumptions regarding feelings, and actions toward others with a focus on generating spontaneous empathy and compassion for themselves and others.
Arm Name:Cognitively-based compassion training
Intervention Type:Other
Name:Resistance training (RT)
Description:Resistance training (RT) will include 15 repetitions for two sets and to exhaustion on the third set for seven major muscle groups: the leg and chest press, knee extension, leg curl, row, abdominal crunch, and bicep curl. Resistance is gradually increased to account for strength gains when subjects are able to complete 20 repetitions on the third set.
Arm Name:Resistance training

Study Arms

Study Arm Type:Active Comparator
Arm Name:Cognitively-based compassion training
Study Arm Type:Experimental
Arm Name:Resistance training

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Emory University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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