NCT01542216

Brief Summary

With the increased success in breast cancer therapies, survivors develop unhealthy changes in body composition, such as muscle loss and fat gains, which lead to increased risk of cardiovascular disease and diabetes in survivorship. This study will examine the effects of a nutrition, cardiovascular and strength exercise program compared with a yoga program (representing usual care) on body composition and metabolism in recently diagnosed breast cancer patients. Nutrition and exercise may improve various body composition and metabolic parameters, which may improve quality of life in survivorship, reduce risk of recurrence and reduce the risk of developing cardiovascular disease and diabetes in survivorship.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

3.3 years

First QC Date

February 20, 2012

Last Update Submit

November 4, 2015

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in glucose parameters from baseline

    Oral glucose tolerance tests will be performed at each assessment. Changes from baseline will be measured.

    Baseline, 8 weeks, 16 weeks

Secondary Outcomes (1)

  • Change in lipid profile relative to baseline

    Baseline, 8 weeks, 16 weeks

Study Arms (2)

Yoga and Stretching Group

PLACEBO COMPARATOR

Patients undergo yoga and stretching exercises

Behavioral: Yoga and Stretching Group

Nutrition and Exercise Group

ACTIVE COMPARATOR

Patients are provided with nutrition, cardiovascular exercise and strength exercise consultations

Behavioral: Nutrition and Exercise Group

Interventions

Nutrition and Exercise GroupBEHAVIORAL

Patients randomized to this arm will receive nutrition and exercise consultations. Exercise consultations will home- and institution-based.

Also known as: Nutrition and Exercise Training
Nutrition and Exercise Group
Yoga and Stretching GroupBEHAVIORAL

Patients randomized to this arm will receive consultations on yoga and stretching exercises.

Also known as: Minimal Exercise
Yoga and Stretching Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females 18 years old or older
  • Recent diagnosis of breast cancer and up to 4 weeks following the first cycle of chemotherapy or up to the first 4 weeks of radiation therapy
  • Clinical Stages I-IIIa
  • Able to communicate freely in English
  • Have sufficient cognitive ability to participate and provide informed consent

You may not qualify if:

  • Any known diagnosis of cardiovascular disease and thyroid disease that is not currently managed with medication or other therapies
  • Any known diagnosis of diabetes or HIV
  • Pre-existing injuries or health conditions that prevents the patient's safe participation in exercise
  • Any previous diagnosis of cancer within the last 5 years (other than carcinoma in situ)
  • Fasting glucose \>7.0 mM at baseline of the study
  • Pregnant individuals will be excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nutritional StatusExerciseYoga

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Marina Mourtzakis, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR
0

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

February 20, 2012

First Posted

March 2, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

CA(1)