Evaluation of Nutrition and Metabolism in Breast Cancer Patients

NCT ID: NCT01542216

Last Updated: 2015-11-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Yoga and Stretching Group

Patients undergo yoga and stretching exercises

Group Type: PLACEBO_COMPARATOR

Yoga and Stretching Group

Intervention Type: BEHAVIORAL

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

Nutrition and Exercise Group

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

Group Type: ACTIVE_COMPARATOR

Nutrition and Exercise Group

Intervention Type: BEHAVIORAL

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

Interventions

Nutrition and Exercise Group

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

Intervention Type: BEHAVIORAL

Yoga and Stretching Group

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Nutrition and Exercise Training; Minimal Exercise

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Grand River Regional Cancer Centre

OTHER

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Mourtzakis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

2011-0463

Identifier Type: OTHER

Identifier Source: secondary_id

17215

Identifier Type: -

Identifier Source: org_study_id