Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102866
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Julia White, Ohio State University Comprehensive Cancer Center

Brief Summary:
This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.

Condition or disease Intervention/treatment Phase
Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Other: Best Practice Behavioral: Exercise Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (Pilot) II. To determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (Phase II)

SECONDARY OBJECTIVES:

I. Percent adherence to exercise at 1 year as measured by the International Physical Activity Questionnaire and exercise logs.

II. Subjective arm health at 1 year as measured by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4).

III. Arm lymphedema at 1 year as measured by arm circumference. IV. Arm range of motion at 1 year as measured by goniometry. V. Quality of life at 1 year as measured by FACT-B+4. VI. Percent increase in arm strength as measured by one repetition maximum at 1 year.

VII. Change in weight and body mass index (BMI) 1 year after completion of radiation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.

ARM II: Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.

After completion of study, patients are followed up at 1 year.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm I (usual care)
Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (aerobic and strength training exercise)
Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
Behavioral: Exercise Intervention
Undergo aerobic and strength training exercise

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot) [ Time Frame: Up to 1 year ]
    determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program.

  2. Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II) [ Time Frame: At 1 year ]
    Will be compared to usual care group.


Secondary Outcome Measures :
  1. Arm lymphedema as measured by arm circumference [ Time Frame: Baseline up to 1 year ]
    Lymphedema will be classified into 3 stages. Stage I edema is reversible and characterized by pitting edema, increase in arm girth, and heaviness. Stage II is characterized by a spongy consistency of the arm without pitting edema. Stage III is the most advanced stage, lymphostatic elephantiasis

  2. Arm range of motion as measured by goniometry [ Time Frame: Baseline up to 1 year ]
    Shoulder flexion, external and internal rotation, and abduction will be measured.

  3. Change in weight and BMI [ Time Frame: Baseline up to 1 year ]
    BMI will be measured to evaluate body composition using the metric formula weight (kg)/ height 2 (m2).

  4. Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs [ Time Frame: Baseline up to 1 year ]
    Generalized linear models will be utilized to model follow-up as a function of baseline and group.

  5. Percent increase in arm strength as measured by one repetition maximum [ Time Frame: Baseline up to 1 year ]
    Change in strength from baseline to post-intervention and follow-up will be obtained.

  6. Quality of life as measured by FACT-B+4 [ Time Frame: Baseline up to 1 year ]
    The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms.

  7. Subjective arm health as measured by FACT-B+4 [ Time Frame: Baseline up to 1 year ]
    The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage II-III breast cancer
  • Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection
  • Prior chemotherapy in the neoadjuvant or adjuvant setting
  • Radiation plan consisting of regional nodal radiation
  • Must be suitable for an exercise program

Exclusion Criteria:

  • Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician
  • Physical handicap that would prevent participation in program
  • Patients with metastatic breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102866


Contacts
Layout table for location contacts
Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu
Contact: Sohyun McElroy 614-685-7050 Sohyun.McElroy@osumc.edu

Locations
Layout table for location information
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Julia White, MD    614-688-7367    Julia.White@osumc.edu   
Principal Investigator: Julia White, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Julia White, MD Ohio State University Comprehensive Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: Julia White, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03102866     History of Changes
Other Study ID Numbers: OSU-16125
NCI-2017-00318 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases