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Evaluation of Nutrition and Metabolism in Breast Cancer Patients

U

University of Waterloo

Status

Withdrawn

Conditions

Breast Cancer

Treatments

Behavioral: Yoga and Stretching Group
Behavioral: Nutrition and Exercise Group

Study type

Interventional

Funder types

Other

Identifiers

NCT01542216
17215
2011-0463 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups, including a placebo group

Yoga and Stretching Group
Placebo Comparator group
Description:
Patients undergo yoga and stretching exercises
Treatment:
Behavioral: Yoga and Stretching Group
Nutrition and Exercise Group
Active Comparator group
Description:
Patients are provided with nutrition, cardiovascular exercise and strength exercise consultations
Treatment:
Behavioral: Nutrition and Exercise Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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