Exercise Program for Early Breast Cancer Survivors

NCT01140282 | Completed DMC

• 2 other identifiers: 1B-12-1NCI-2010-01265
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Exercise therapy may improve the quality of life of breast cancer survivors. Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.

Conditions

Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Keywords

cancer survivor

Outcome Measures

Primary Outcomes (4)

• Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c

  At week 16

• Improvement of physical fitness, cardiorespiratory fitness, and muscle strength

  At week 16

• Feasibility of a supervised exercise program for cancer survivors

  At week 16

• Maintain positive benefits of an exercise intervention

  12 weeks post-intervention

Study Arms (2)

Arm I (Control)

ACTIVE COMPARATOR

Patients refrain from increasing physical activity levels for 16 weeks.

Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications

Arm II (Exercise)

EXPERIMENTAL

Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks.

Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications; Behavioral: exercise intervention

Interventions

questionnaire administration OTHER

Administered within 3 days of baseline testing and at post-trial visit

Arm I (Control); Arm II (Exercise)

quality-of-life assessment PROCEDURE

Administered within 3 days of baseline testing and at post-trial visit

Also known as: quality of life assessment

Arm I (Control); Arm II (Exercise)

management of therapy complications PROCEDURE

Assessed within 3 days of baseline testing and at post-trial visit

Also known as: complications of therapy, management of

Arm I (Control); Arm II (Exercise)

exercise intervention BEHAVIORAL

12 week exercise intervention

Arm II (Exercise)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed (I-III) with a first primary invasive breast cancer
• Have undergone a lumpectomy or mastectomy
• Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program (if randomized to that arm) within 12 weeks of therapy completion
• Body mass index (BMI) \> 25 kg/m\^2 or body fat \> 30% (determined by Dr. Dieli-Conwright at baseline visit)
• Currently participate in less than 60 minutes of physical activity per week May use adjuvant endocrine therapy if use will be continued for duration of study period
• Nonsmokers (i.e., not smoking during previous 12 months)
• Willing to travel to the exercise facility and USC
• Able to provide physician clearance to participate in exercise program
• Women of all racial and ethnic backgrounds will be included in the study enrollment process

You may not qualify if:

• History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
• Weight reduction \>= 10% within past 6 months
• Metastatic disease
• Planned reconstructive surgery with flap repair during trial and follow-up period
• Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

Location

Related Publications (8)

• Dieli-Conwright CM, Sami N, Norris MK, Wan J, Kumagai H, Kim SJ, Cohen P. Effect of aerobic and resistance exercise on the mitochondrial peptide MOTS-c in Hispanic and Non-Hispanic White breast cancer survivors. Sci Rep. 2021 Aug 19;11(1):16916. doi: 10.1038/s41598-021-96419-z.

  PMID: 34413391 DERIVED

• Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Norris MK, Fox FS, Buchanan TA, Spicer D, Bernstein L, Tripathy D. Aerobic and resistance exercise improve patient-reported sleep quality and is associated with cardiometabolic biomarkers in Hispanic and non-Hispanic breast cancer survivors who are overweight or obese: results from a secondary analysis. Sleep. 2021 Oct 11;44(10):zsab111. doi: 10.1093/sleep/zsab111.

  PMID: 33929533 DERIVED

• Lee K, Sami N, Tripathy D, Demark-Wahnefried W, Norris MK, Courneya KS, Dieli-Conwright CM. Aerobic and resistance exercise improves Reynolds risk score in overweight or obese breast cancer survivors. Cardiooncology. 2020 Nov 24;6(1):27. doi: 10.1186/s40959-020-00084-6.

  PMID: 33292676 DERIVED

• Sweeney FC, Demark-Wahnefried W, Courneya KS, Sami N, Lee K, Tripathy D, Yamada K, Buchanan TA, Spicer DV, Bernstein L, Mortimer JE, Dieli-Conwright CM. Aerobic and Resistance Exercise Improves Shoulder Function in Women Who Are Overweight or Obese and Have Breast Cancer: A Randomized Controlled Trial. Phys Ther. 2019 Oct 28;99(10):1334-1345. doi: 10.1093/ptj/pzz096.

  PMID: 31309977 DERIVED

• Lee K, Tripathy D, Demark-Wahnefried W, Courneya KS, Sami N, Bernstein L, Spicer D, Buchanan TA, Mortimer JE, Dieli-Conwright CM. Effect of Aerobic and Resistance Exercise Intervention on Cardiovascular Disease Risk in Women With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):710-714. doi: 10.1001/jamaoncol.2019.0038.

  PMID: 30920602 DERIVED

• Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Sweeney FC, Stewart C, Buchanan TA, Spicer D, Tripathy D, Bernstein L, Mortimer JE. Aerobic and resistance exercise improves physical fitness, bone health, and quality of life in overweight and obese breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2018 Oct 19;20(1):124. doi: 10.1186/s13058-018-1051-6.

  PMID: 30340503 DERIVED

• Dieli-Conwright CM, Courneya KS, Demark-Wahnefried W, Sami N, Lee K, Buchanan TA, Spicer DV, Tripathy D, Bernstein L, Mortimer JE. Effects of Aerobic and Resistance Exercise on Metabolic Syndrome, Sarcopenic Obesity, and Circulating Biomarkers in Overweight or Obese Survivors of Breast Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Mar 20;36(9):875-883. doi: 10.1200/JCO.2017.75.7526. Epub 2018 Jan 22.

  PMID: 29356607 DERIVED

• Dieli-Conwright CM, Mortimer JE, Schroeder ET, Courneya K, Demark-Wahnefried W, Buchanan TA, Tripathy D, Bernstein L. Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods. BMC Cancer. 2014 Apr 3;14:238. doi: 10.1186/1471-2407-14-238.

  PMID: 24708832 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christina Dieli-Conwright, Ph.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 9, 2010
• Study Start: May 21, 2012
• Primary Completion: September 28, 2017
• Study Completion: October 1, 2018
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

US (1)