Evaluation of Nutrition and Metabolism in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Evaluation of Nutrition and Metabolism in Breast Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01542216
• Other study ID #: 17215
• Secondary ID: 2011-0463
• Status: Withdrawn
• Phase: N/A
• First received: February 20, 2012
• Last updated: November 4, 2015
• Start date: February 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Nutrition and Exercise Group
Patients randomized to this arm will receive nutrition and exercise consultations. Exercise consultations will home- and institution-based.
• Yoga and Stretching Group
Patients randomized to this arm will receive consultations on yoga and stretching exercises.

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Grand River Regional Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in lipid profile relative to baseline		Baseline, 8 weeks, 16 weeks	No