Evaluation of Nutrition and Metabolism in Breast Cancer Patients

This study is currently recruiting participants.
Verified February 2012 by University of Waterloo
Sponsor:
Collaborator:
Grand River Regional Cancer Centre
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT01542216
First received: February 20, 2012
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Nutrition and Exercise Group
Behavioral: Yoga and Stretching Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Nutrition and Metabolism in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Change in glucose parameters from baseline [ Time Frame: Baseline, 8 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Oral glucose tolerance tests will be performed at each assessment. Changes from baseline will be measured.


Secondary Outcome Measures:
  • Change in lipid profile relative to baseline [ Time Frame: Baseline, 8 weeks, 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Yoga and Stretching Group
Patients undergo yoga and stretching exercises
Behavioral: Yoga and Stretching Group
Patients randomized to this arm will receive consultations on yoga and stretching exercises.
Other Name: Minimal Exercise
Active Comparator: Nutrition and Exercise Group
Patients are provided with nutrition, cardiovascular exercise and strength exercise consultations
Behavioral: Nutrition and Exercise Group
Patients randomized to this arm will receive nutrition and exercise consultations. Exercise consultations will home- and institution-based.
Other Name: Nutrition and Exercise Training

Detailed Description:

Despite the increased success of novel anti-neoplastic therapies, breast cancer patients receiving chemotherapy develop unfavourable changes in body composition, including lean tissue loss and fat gains (1,2). These detrimental changes associate with poor quality of life (3,4) and may lead to treatment complications (5,6) during the cancer trajectory. In non-malignant populations, fat gain and muscle loss associate with increased risk of cardiovascular disease and diabetes (7). Cancer survivors who gain fat and lose lean mass are not only predisposed to these diseases but also have an increased risk of cancer recurrence (3). Proper nutrition as well as exercise can independently improve metabolic profiles (i.e. immune function, lipid and glucose metabolism) and overall health outcomes in non-malignant populations (7-9). While exercise has enhanced quality of life in breast cancer patients (4), overall nutritional needs and the metabolic benefits of exercise are unclear in this patient group. Understanding the effects of nutrition and exercise interventions in breast cancer patients will form the basis for future studies and programs that integrate nutrition, exercise, and metabolism to reduce cancer recurrence and other morbidities in survivorship. This study will examine the effects of nutrition and exercise intervention on body composition and metabolism in recently diagnosed breast cancer patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542216

Contacts
Contact: Marina Mourtzakis, PhD 519-888-4567 ext 38459 mmourtza@uwaterloo.ca

Locations
Canada, Ontario
University of Waterloo Recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Marina Mourtzakis, PhD    519-888-4567 ext 38459    mmourtza@uwaterloo.ca   
Principal Investigator: Marina Mourtzakis, PhD         
Sponsors and Collaborators
University of Waterloo
Grand River Regional Cancer Centre
Investigators
Principal Investigator: Marina Mourtzakis, PhD University of Waterloo
  More Information

No publications provided

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01542216     History of Changes
Other Study ID Numbers: 17215, 2011-0463
Study First Received: February 20, 2012
Last Updated: February 24, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on April 15, 2014