CancerNCT03539835
Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
A study testing Resistance training (RT) in people with Cancer, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Resistance training (RT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer,
- at least 6 months post breast reconstruction (if applicable),
- lack of menses for at least one year,
- BMI 20-35 kg/m2,
- fatigued (subjective reporting ≥3 on a 1-10 scale),
- untrained with regard to structured resistance training (no more than 3x/week).
Who cannot join
- plans for surgery (e.g., breast reconstruction) during the study period,
- taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban),
- allergic to lidocaine,
- orthopedic or chronic pain condition restricting exercise,
- 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),
- unable to receive physician medical clearance.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- Resistance training (RT), Cognitively-based compassion training control (CBCT)
- Keywords
- Breast Cancer Survivors, Resistance Training, Fatigue, Physical Function, Behavioral Function, Kynurenine metabolism
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training (RT)Other
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.
Cognitively-based compassion training control (CBCT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Not described Receives: Other: Resistance training (RT) |
| Cognitively-based compassion training | Active comparator | Not described Receives: Behavioral: Cognitively-based compassion training control (CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score
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 contains four items for which the person had to indicate on a seven-point scale to what extent the particular statement applies to him or her. An equal number of items is worded in a positive and in a negative direction to counteract response tendencies.
Measured: Baseline, 12 weeks follow up
Secondary outcomes (14)
Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score
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.
Measured: Baseline, 12 weeks follow up
Change in balance test score
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.
Measured: Baseline, 12 weeks follow up
Change in muscle function assessed by Isometric Handgrip test.
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 "squeeze as hard as possible" during 3-5 second efforts.
Measured: Baseline, 12 weeks follow up
Change in muscle function assessed by Lower Extremity Endurance test
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 equipment that is built to isolate single leg movement.
Measured: Baseline, 12 weeks follow up
Change in muscle function assessed by Lower Extremity Strength test
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.
Measured: Baseline, 12 weeks follow up
Change in Timed Up and Go (TUG) completion time
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.
Measured: Baseline, 12 weeks follow up
Change in 30 meter walk velocity
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."
Measured: Baseline, 12 weeks follow up
Change in Functional Gait Assessment score
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. A total score out of a maximum of 30 points will be reported.
Measured: Baseline, 12 weeks follow up
Change in 6 min walk distance
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.
Measured: Baseline, 12 weeks follow up
Change in Resting Metabolic Rate (RMR)
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 reported as a continuous variable of kilocalories/day.
Measured: Baseline, 12 weeks follow up
Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) level
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.
Measured: Baseline, 12 weeks follow up
Change in kynurenic acid level
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. .
Measured: Baseline, 12 weeks follow up
Change in interleukin-6 (IL-6) level
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.
Measured: Baseline, 12 weeks follow up
Change in tumor necrosis factor-α (TNF-α) protein level
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 sample.
Measured: Baseline, 12 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start10 Dec 2018
- Primary completion9 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Nocera, Emory University
- Investigators
- Monica Serra, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539835
- Sponsor's protocol ID
- IRB00103558
- Status last verified
- Jul 2020
- First submitted
- 16 May 2018
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03539835
- Acronym / sponsor ID
- IRB00103558
- Conditions
- Cancer
- Keywords
- Breast Cancer Survivors, Resistance Training, Fatigue, Physical Function, Behavioral Function, Kynurenine metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance training (RT) |
| Cognitively-based compassion training | Active comparator | Behavioral: Cognitively-based compassion training control (CBCT) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer,
- at least 6 months post breast reconstruction (if applicable),
- lack of menses for at least one year,
- BMI 20-35 kg/m2,
- fatigued (subjective reporting ≥3 on a 1-10 scale),
Key exclusion criteria (6 listed)
- plans for surgery (e.g., breast reconstruction) during the study period,
- taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban),
- allergic to lidocaine,
- orthopedic or chronic pain condition restricting exercise,
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance training (RT)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. | Other | Resistance training |
| Cognitively-based compassion training control (CBCT)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. | Behavioural | Cognitively-based compassion training |
Primary outcome
Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score
Time frame: Baseline, 12 weeks follow up
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 contains four items for which the person had to indicate on a seven-point scale to what extent the particular statement applies to him or her. An equal number of items is worded in a positive and in a negative direction to counteract response tendencies.
14 secondary outcomes
Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score
Time frame: Baseline, 12 weeks follow up
Change in balance test score
Time frame: Baseline, 12 weeks follow up
Change in muscle function assessed by Isometric Handgrip test.
Time frame: Baseline, 12 weeks follow up
Change in muscle function assessed by Lower Extremity Endurance test
Time frame: Baseline, 12 weeks follow up
Change in muscle function assessed by Lower Extremity Strength test
Time frame: Baseline, 12 weeks follow up
Change in Timed Up and Go (TUG) completion time
Time frame: Baseline, 12 weeks follow up
Change in 30 meter walk velocity
Time frame: Baseline, 12 weeks follow up
Change in Functional Gait Assessment score
Time frame: Baseline, 12 weeks follow up
Change in 6 min walk distance
Time frame: Baseline, 12 weeks follow up
Change in Resting Metabolic Rate (RMR)
Time frame: Baseline, 12 weeks follow up
Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) level
Time frame: Baseline, 12 weeks follow up
Change in kynurenic acid level
Time frame: Baseline, 12 weeks follow up
Change in interleukin-6 (IL-6) level
Time frame: Baseline, 12 weeks follow up
Change in tumor necrosis factor-α (TNF-α) protein level
Time frame: Baseline, 12 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Serra, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training (RT) in people with Cancer, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score (time frame: Baseline, 12 weeks follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.