Exercise Training in Postmenopausal Patients With Breast Cancer

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status: Completed

Conditions: Physical Activity

Treatments: Behavioral: physical activity; Behavioral: Counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01384838

AGMT_BC_Sports

Details and patient eligibility

About

This randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program.

All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized.

All patients are to receive identical counseling for ideal nutritional, life-style and physical activity.

Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.

Enrollment: 80 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Postmenopausal women with hormone receptor positive breast cancer (as defined by HR >= ++ and/or PR >= ++) who are treated with aromatase inhibitors
• ECOG performance status <= 2
• all age groups

Exclusion criteria

• Pathologic ergometry
• Uncontrolled diabetes mellitus
• Uncontrolled hypertension
• COPD > II
• Active opportunistic infection
• NYHA heart failure III or IV

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Counseling

Other group

Description:

Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.

Treatment:

Behavioral: Counseling

Controlled physical activity

Experimental group

Description:

All patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity. Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.

Treatment:

Behavioral: physical activity