NCT02592070

Brief Summary

This study addresses an important public health concern; impoverished cognitive function associated with treatment of breast cancer. Due to increased awareness of breast cancer combined with advances in medical care, there are over 2.8 million women living with a history of breast cancer in the U.S. alone. Chemotherapy and adjuvant therapy to remove cancerous tissue can result in deficits in attention, speed of processing, memory, and quality of life. Physical activity has been associated with a number of health benefits for breast cancer survivors including improvements in cognitive function. However, most of the literature is cross-sectional and it is unclear whether acute (single) bouts of physical activity affect cognition and, if they do, how long this effect lasts. This study will be the first, to the investigators' knowledge, to examine the effects of an acute bout of aerobic exercise on cognitive functioning in breast cancer survivors. Specifically, the investigators will determine the effects of a 30-minute moderate intensity aerobic exercise session (treadmill walking) on immediate and one hour follow up changes in measures of processing speed, memory, and executive function. Additionally, accelerometer cut-points for physical activity intensities in breast cancer survivors will be assessed. Finally, the investigators will examine the association of cardiorespiratory fitness and physical activity with changes in cognitive function. Findings from this study will allow researchers to determine whether any acute effects of exercise on cognition are retained over time and therefore have real meaning in the context of one's daily life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

August 25, 2015

Last Update Submit

February 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in cognitive function in breast cancer survivors immediately and one hour after an acute bout of exercise as assessed by a battery of cognitive functioning measures.

    Participants will complete cognitive tasks, then exercise on a treadmill for 30 minutes before completing the same cognitive tasks again. Participants will then rest before completing the cognitive tasks one more time one hour after the end of the exercise period.

    1 year

Secondary Outcomes (4)

  • Change in relationship between exercise and cognitive function in breast cancer survivors as assessed by physical activity and fitness levels.

    1 year

  • Physical activity guidelines in breast cancer survivors as assessed by graded exercise test.

    60 minutes

  • Change from baseline in anxiety levels after one bout of exercise as assessed by HADS questionnaire.

    30 minutes

  • Change in relationship between exercise and cognitive function in breast cancer survivors as assessed by psychosocial questionnaires.

    1 year

Study Arms (1)

30 minute treadmill walking

EXPERIMENTAL

All participants will walk on the treadmill for 30 minutes and perform a battery of cognitive tasks immediately prior, immediately after, and one hour after completion of the 30 minute walking period.

Behavioral: Walking

Interventions

WalkingBEHAVIORAL

Participants will walk on the treadmill for 30 minutes at a moderate intensity.

30 minute treadmill walking

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women between 30 and 60 years of age
  • diagnosis of breast cancer
  • no longer undergoing treatment
  • fluent in English
  • no history of dementia or organic brain syndrome
  • not currently pregnant
  • able to walk unassisted
  • no health reasons that would prevent ability to exercise
  • not currently enrolled in another exercise research study
  • reported trouble with memory/concentration
  • physician's consent

You may not qualify if:

  • male
  • no diagnosis of breast cancer
  • outside of 30-60 years of age
  • currently undergoing treatment for breast cancer
  • inability to communicate in English
  • history of dementia or organic brain syndrome
  • pregnant
  • unable to walk unassisted
  • other health reasons that may prevent ability to exercise
  • enrolled in another exercise research study
  • no reported trouble with memory or concentration
  • non-consent of physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freer Hall, University of Illinois

Urbana, Illinois, 61801, United States

Location

Related Publications (15)

  • Bray F, McCarron P, Parkin DM. The changing global patterns of female breast cancer incidence and mortality. Breast Cancer Res. 2004;6(6):229-39. doi: 10.1186/bcr932. Epub 2004 Aug 26.

    PMID: 15535852BACKGROUND
  • Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) Research Data (2004-2010), National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2014, based on the November 2013 submission.

    BACKGROUND
  • van Harten WH, van Noort O, Warmerdam R, Hendricks H, Seidel E. Assessment of rehabilitation needs in cancer patients. Int J Rehabil Res. 1998 Sep;21(3):247-57. doi: 10.1097/00004356-199809000-00001.

    PMID: 9812254BACKGROUND
  • Goodwin JS, Samet JM, Hunt WC. Determinants of survival in older cancer patients. J Natl Cancer Inst. 1996 Aug 7;88(15):1031-8. doi: 10.1093/jnci/88.15.1031.

    PMID: 8683633BACKGROUND
  • Pinto AC, de Azambuja E. Improving quality of life after breast cancer: dealing with symptoms. Maturitas. 2011 Dec;70(4):343-8. doi: 10.1016/j.maturitas.2011.09.008. Epub 2011 Oct 19.

    PMID: 22014722BACKGROUND
  • Kesler S, Hadi Hosseini SM, Heckler C, Janelsins M, Palesh O, Mustian K, Morrow G. Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. Clin Breast Cancer. 2013 Aug;13(4):299-306. doi: 10.1016/j.clbc.2013.02.004. Epub 2013 May 4.

    PMID: 23647804BACKGROUND
  • Koppelmans V, Breteler MM, Boogerd W, Seynaeve C, Gundy C, Schagen SB. Neuropsychological performance in survivors of breast cancer more than 20 years after adjuvant chemotherapy. J Clin Oncol. 2012 Apr 1;30(10):1080-6. doi: 10.1200/JCO.2011.37.0189. Epub 2012 Feb 27.

    PMID: 22370315BACKGROUND
  • Hillman CH, Erickson KI, Kramer AF. Be smart, exercise your heart: exercise effects on brain and cognition. Nat Rev Neurosci. 2008 Jan;9(1):58-65. doi: 10.1038/nrn2298.

    PMID: 18094706BACKGROUND
  • Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.

    PMID: 20559064BACKGROUND
  • Galantino ML, Greene L, Daniels L, Dooley B, Muscatello L, O'Donnell L. Longitudinal impact of yoga on chemotherapy-related cognitive impairment and quality of life in women with early stage breast cancer: a case series. Explore (NY). 2012 Mar-Apr;8(2):127-35. doi: 10.1016/j.explore.2011.12.001.

    PMID: 22385567BACKGROUND
  • Baumann, F. T., Drosselmeyer, N., Leskaroski, A., Knicker, A., Krakowski-Roosen, H., Zopf, E. M., & Bloch, W. (2011). 12-week resistance training with breast cancer patients during chemotherapy: Effects on cognitive abilities. Breast Care, 6(2), 142-143.

    BACKGROUND
  • Irwin ML, McTiernan A, Bernstein L, Gilliland FD, Baumgartner R, Baumgartner K, Ballard-Barbash R. Physical activity levels among breast cancer survivors. Med Sci Sports Exerc. 2004 Sep;36(9):1484-91.

    PMID: 15354027BACKGROUND
  • Mackenzie, M., Zuniga, K., & McAuley, E. (in press). Cognitive impairment in breast cancer survivors: The protective role of physical activity, cardiorespiratory fitness, and exercise training. Exercise-Cognition Interaction: Neuroscience Perspectives.

    BACKGROUND
  • Blacklock R, Rhodes R, Blanchard C, Gaul C. Effects of exercise intensity and self-efficacy on state anxiety with breast cancer survivors. Oncol Nurs Forum. 2010 Mar;37(2):206-12. doi: 10.1188/10.ONF.206-212.

    PMID: 20189926BACKGROUND
  • Salerno EA, Rowland K, Kramer AF, McAuley E. Acute aerobic exercise effects on cognitive function in breast cancer survivors: a randomized crossover trial. BMC Cancer. 2019 Apr 23;19(1):371. doi: 10.1186/s12885-019-5589-1.

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCognitive DysfunctionMotor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCognition DisordersNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Edward McAuley, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shahid and Ann Carlson Khan Professor in Applied Health Sciences

Study Record Dates

First Submitted

August 25, 2015

First Posted

October 30, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations