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Completed

NCT Number: NCT03539835

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score

    Time frame: Baseline, 12 weeks follow up

    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.

  2. Change in balance test score

    Time frame: Baseline, 12 weeks follow up

    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.

  3. Change in muscle function assessed by Isometric Handgrip test.

    Time frame: Baseline, 12 weeks follow up

    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.

  4. Change in muscle function assessed by Lower Extremity Endurance test

    Time frame: Baseline, 12 weeks follow up

    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.

  5. Change in muscle function assessed by Lower Extremity Strength test

    Time frame: Baseline, 12 weeks follow up

    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.

  6. Change in Timed Up and Go (TUG) completion time

    Time frame: Baseline, 12 weeks follow up

    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.

  7. Change in 30 meter walk velocity

    Time frame: Baseline, 12 weeks follow up

    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."

  8. Change in Functional Gait Assessment score

    Time frame: Baseline, 12 weeks follow up

    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.

  9. Change in 6 min walk distance

    Time frame: Baseline, 12 weeks follow up

    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.

  10. Change in Resting Metabolic Rate (RMR)

    Time frame: Baseline, 12 weeks follow up

    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.

  11. Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) level

    Time frame: Baseline, 12 weeks follow up

    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.

  12. Change in kynurenic acid level

    Time frame: Baseline, 12 weeks follow up

    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. .

  13. Change in interleukin-6 (IL-6) level

    Time frame: Baseline, 12 weeks follow up

    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.

  14. Change in tumor necrosis factor-α (TNF-α) protein level

    Time frame: Baseline, 12 weeks follow up

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 29, 2018
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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