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Evaluation of Nutrition and Metabolism in Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nutrition and Exercise Group
Yoga and Stretching Group
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Yoga and Stretching Group

Nutrition and Exercise Group

Arm Description

Patients undergo yoga and stretching exercises

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

Outcomes

Primary Outcome Measures

Change in glucose parameters from baseline
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

Full Information

First Posted
February 20, 2012
Last Updated
November 4, 2015
Sponsor
University of Waterloo
Collaborators
Grand River Regional Cancer Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01542216
Brief Title
Evaluation of Nutrition and Metabolism in Breast Cancer Patients
Official Title
Evaluation of Nutrition and Metabolism in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment challenges
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
Collaborators
Grand River Regional Cancer Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga and Stretching Group
Arm Type
Placebo Comparator
Arm Description
Patients undergo yoga and stretching exercises
Arm Title
Nutrition and Exercise Group
Arm Type
Active Comparator
Arm Description
Patients are provided with nutrition, cardiovascular exercise and strength exercise consultations
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and Exercise Group
Other Intervention Name(s)
Nutrition and Exercise Training
Intervention Description
Patients randomized to this arm will receive nutrition and exercise consultations. Exercise consultations will home- and institution-based.
Intervention Type
Behavioral
Intervention Name(s)
Yoga and Stretching Group
Other Intervention Name(s)
Minimal Exercise
Intervention Description
Patients randomized to this arm will receive consultations on yoga and stretching exercises.
Primary Outcome Measure Information:
Title
Change in glucose parameters from baseline
Description
Oral glucose tolerance tests will be performed at each assessment. Changes from baseline will be measured.
Time Frame
Baseline, 8 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Change in lipid profile relative to baseline
Time Frame
Baseline, 8 weeks, 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Mourtzakis, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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Evaluation of Nutrition and Metabolism in Breast Cancer Patients

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