Aerobic Training in Metastatic Breast Cancer (Breast Mets)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01725633
First received: July 28, 2011
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine the safety and feasibility of supervised aerobic training in women undergoing hormone therapy, chemotherapy, and/or radiation therapy for metastatic breast cancer. Previous research among persons with breast cancer has shown that breast cancer therapy is associated with side-effects that affect fitness and quality of life. Therefore, the investigators want to determine if aerobic training is appropriate for this population. To date, no study has tested this question and this is the reason for the study.


Condition Intervention
Metastatic Breast Cancer
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Trial of Aerobic Training in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Aerobic Training [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To determine the feasibility and safety of supervised aerobic training in women receiving endocrine therapy, chemotherapy, and/or radiotherapy for metastatic breast cancer. Safety and feasibility evaluated by assessing the rates of study eligibility, overall accrual, attrition, and exercise adherence. Safety will be evaluated by the type and prevalence of adverse events during study-related assessments and aerobic training sessions. Tracking and monitoring of exercise-related adverse events will be assessed using the following methods: (1) stringent monitoring and recording (in the patient case report form; case report form, this will include a detailed past medical history, complete blood count panel history from first line chemotherapy, and detailed medication information) of physiologic outcomes and vital signs (e.g., heart rate, blood pressure, etc.) prior to, during, and following every intervention session


Secondary Outcome Measures:
  • Treatment toxicities and Patient Symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    • To explore the potential effect (means and variation) on treatment toxicity, patient symptoms, and functional capacity, relative to attention control (i.e., mock exercise)
    • To explore the potential effect (means and variation) on biomarkers associated with metastatic breast cancer prognosis (i.e., inflammatory cytokines and growth factors), relative to attention control


Estimated Enrollment: 72
Study Start Date: December 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stretching
The progressive stretching program will be prescribed according the American College of Sports Medicine guidelines for older adults and aimed at increasing whole-body flexibility.98 The ultimate goal for the progressive stretching program is 3 stretching sessions/week for 30-45 minutes/session.
Behavioral: Exercise
Study interventions are aerobic training or attention-control progressive stretching. Both interventions will be matched in terms of social interaction (participants will receive one-on-one instruction), duration (30-45 mins/session), and program length (12 weeks). All intervention sessions, including attention-control stretching, will be performed in a supervised setting with one-on-one supervision by an American College of Sports Medicine (ACSM)-certified exercise physiologist
Experimental: Aerobic Exercise
Aerobic training will be prescribed according to American College of Sports Medicine guidelines.97 The ultimate goal for the aerobic training group is 3 supervised exercise sessions per week at 50% to 70% of the individually determined VO2peak for 30-45 minutes/session for 12 weeks. Participants will be able to choose between either cycling or treadmill walking to achieve the prescribed aerobic prescription.
Behavioral: Exercise
Study interventions are aerobic training or attention-control progressive stretching. Both interventions will be matched in terms of social interaction (participants will receive one-on-one instruction), duration (30-45 mins/session), and program length (12 weeks). All intervention sessions, including attention-control stretching, will be performed in a supervised setting with one-on-one supervision by an American College of Sports Medicine (ACSM)-certified exercise physiologist

Detailed Description:

Primary To determine the feasibility and safety of supervised aerobic training in women receiving endocrine therapy, chemotherapy, and/or radiotherapy for metastatic breast cancer

Secondary

  • To explore the potential effect (means and variation) on treatment toxicity, patient symptoms, and functional capacity, relative to attention control (i.e., mock exercise)
  • To explore the potential effect (means and variation) on biomarkers associated with metastatic breast cancer prognosis (i.e., inflammatory cytokines and growth factors), relative to attention control

Primary: Safety and feasibility evaluated by assessing the rates of study eligibility, overall accrual, attrition, and exercise adherence. Safety will be evaluated by the type and prevalence of adverse events during study-related assessments and aerobic training sessions. Tracking and monitoring of exercise-related adverse events will be assessed using the following methods: (1) stringent monitoring and recording (in the patient case report form; case report form, this will include a detailed past medical history, complete blood count panel history from first line chemotherapy, and detailed medication information) of physiologic outcomes and vital signs (e.g., heart rate, blood pressure, etc.) prior to, during, and following every intervention session, and (2) at the beginning of each week, the exercise physiologist will spend the first 10 minutes of every session discussing any potential negative side-effects of the intervention assignment and any injuries that may have occurred. Discussions will include topics such as sleep, depression, diet, exercise, and any other related topics that should come up. All events will be recorded in the patient CRF, (3) every two weeks all patients will complete the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 questionnaire. The CTCAE, developed by the NCI, tracks treatment toxicity and adverse events applicable to all oncology clinical trials regardless of chronicity or modality, (4) every three months a meeting of all investigators will be scheduled to review and discuss all reported non-serious and serious adverse events for early identification of negative issues and development of solutions. All serious adverse events will be immediately reported to Duke Institutional Review Board and immediately circulated to all study investigators for appropriate discussion, and (5) early stopping rules in response to a differential higher frequency of adverse events in a particular study group (Risk outweighs benefit as determined by primary investigator and oncologist).

Secondary:

  1. Treatment toxicity and complete blood count panel will be assessed after every chemotherapy cycle or every month if on hormone or radiation therapy according to the CTCAE v.4.0 as described above.
  2. Insulin sensitivity as assessed by an oral glucose tolerance test,
  3. Exercise capacity as measured by a symptom-limited cardiopulmonary exercise test,
  4. Pulmonary function as assessed by hand held spirometry,
  5. Cardiac function as assessed by echocardiography at rest and exercise,
  6. Neurocognitive function (a computerized neurocognitive test battery called Central Nervous System Vital Signs including verbal memory test, visual memory test, finger tapping test, symbol digit coding, Stroop test, shifting attention test, continuous performance test, four part continuous performance test).
  7. Autonomic function as assessed by beat-to-beat heart, blood pressure, and cerebrovascular blood flow velocity via transcranial Doppler.
  8. Patient-reported outcomes will be determined using standardized and validated questionnaires to assess quality of life, fatigue, and other common patient symptoms.
  9. Systemic Cytokines / Angiogenic Factors assessed in fasted blood and prepared for multiplex assay analysis using Luminex 100/200 System (Luminex Corp, Austin, Tx; http://www.luminexcorp.com/products/luminex_200.html).
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Consecutive women with histologically confirmed or cytologically confirmed metastatic breast cancer (MBC) presenting at Duke University Medical Center (DUMC), Durham Regional Hospital, or Duke Raleigh will be potentially eligible. Other major specific inclusion criteria are as follows:

  1. Candidates receiving hormone therapy, chemotherapy, and/or radiotherapy for MBC
  2. Complete radiology and tumor measurement within a maximum of 4 weeks prior to study entry,
  3. ≥21 years of age,
  4. Life expectancy >3 months to ensure recruited patients can complete the 3-month intervention,
  5. Performance status ≥70%, as assessed by the Karnofsky performance status (KPS) scoring system. KPS involves the subjective evaluation of patients' global physical functioning and capability of independent living and self-care as determined by oncology professionals,
  6. Sedentary (i.e., women not performing regular exercise on at least 5 days a week, for at least 30 minutes each session, at a moderate or vigorous intensity for the past month). This definition is consistent with the national exercise recommendations guidelines and will ensure that only women not currently engaging in regular exercise (i.e., those who are the most likely to benefit) are recruited,
  7. Normal cardiac function (left ventricular ejection fraction ≥50%), and
  8. Medical clearance from attending oncologist to undergo supervised exercise training.

Previous treatment with an anthracycline, taxane, angiogenesis inhibition, or hormonal therapy in the neoadjuvant or adjuvant setting is allowed.

Exclusion Criteria:

  1. Radiographic evidence of central nervous system disease, and
  2. Contraindications to aerobic training (e.g., extensive skeletal metastases, coronary artery disease, severe anemia, etc.) as recommended for cancer patients.43 Extensive skeletal metastases will be defined for purposes of this study as greater than five (5) sites of bony disease, or any symptomatic site of disease in the spine, hip, or femur. As above, all patients must additionally receive medical clearance to undergo a trial of supervised exercise for MBC from their primary attending oncologist.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725633

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01725633     History of Changes
Other Study ID Numbers: Pro00025906
Study First Received: July 28, 2011
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014