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

NCT ID: NCT03539835

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2020-03-12

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Resistance training

Group Type: EXPERIMENTAL

Resistance training (RT)

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Cognitively-based compassion training control (CBCT)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Joe Nocera

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Serra, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00103558

Identifier Type: -

Identifier Source: org_study_id