Clinical trial NCT03539835: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Breast Cancer Survivors
Resistance Training
Fatigue
Physical Function
Behavioral Function
Kynurenine metabolism
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 28
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score
timeFrame: Baseline, 12 weeks follow up
Secondary outcomes:
measure: Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score
timeFrame: Baseline, 12 weeks follow up
measure: Change in balance test score
timeFrame: Baseline, 12 weeks follow up
measure: Change in muscle function assessed by Isometric Handgrip test.
timeFrame: Baseline, 12 weeks follow up
measure: Change in muscle function assessed by Lower Extremity Endurance test
timeFrame: Baseline, 12 weeks follow up
measure: Change in muscle function assessed by Lower Extremity Strength test
timeFrame: Baseline, 12 weeks follow up
measure: Change in Timed Up and Go (TUG) completion time
timeFrame: Baseline, 12 weeks follow up
measure: Change in 30 meter walk velocity
timeFrame: Baseline, 12 weeks follow up
measure: Change in Functional Gait Assessment score
timeFrame: Baseline, 12 weeks follow up
measure: Change in 6 min walk distance
timeFrame: Baseline, 12 weeks follow up
measure: Change in Resting Metabolic Rate (RMR)
timeFrame: Baseline, 12 weeks follow up
measure: Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) level
timeFrame: Baseline, 12 weeks follow up
measure: Change in kynurenic acid level
timeFrame: Baseline, 12 weeks follow up
measure: Change in interleukin-6 (IL-6) level
timeFrame: Baseline, 12 weeks follow up
measure: Change in tumor necrosis factor-α (TNF-α) protein level
timeFrame: Baseline, 12 weeks follow up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University
name: Monica Serra, MD
role: PRINCIPAL_INVESTIGATOR
References: