Life ImproVed by Exercise (LIVE Trial)

European Institute of Oncology

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Increased Physical Activity

Study type

Interventional

Funder types

Other

Identifiers

NCT02637765

IEO 121

Details and patient eligibility

About

This is a prospective randomized controlled trial in which patients with previous breast cancer will be randomized into two treatment arms:

Control Group of Usual Physical Activity
Intervention Group of Increased Physical Activity

No specific intervention will be performed In the patients randomized in the control group.

Patients randomized in the Intervention group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week).

All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able to count the number of steps, determine a daily goal of steps, determine the covered distance (in Km), determine daily caloric consumption, and determine the movements during sleep.

Full description

In this prospective randomized controlled trial patients with previous breast cancer will be randomized into two treatment arms:

Control Group of Usual Physical Activity
Intervention Group of Increased Physical Activity

No specific intervention will be performed In the patients randomized in the control group.

Patients randomized in the Intervention Group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week).

Data will be downloaded in a specific application available online (Garmin Connect).

All the patients will receive written information on the potential benefits of physical exercise and better lifestyle.

At baseline, at the end of the study period (8 weeks) and after 1 year patients will be asked to fill out the following questionnaires:

Funcional Assessment of Cancer Therapy- Breast (FACT-B, 37 items)
Patient reported symptoms (PRS like International Breast Cancer Study Group form, 19 items)
Funcional Assessment of Cancer Therapy- Fatigue (FACT-Fatigue, 13 items)
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog; 37 items)
Impact of Event Scale (IES; 22 items)

At baseline, at the end of the study period (8 weeks) patients will be asked to undergo blood draw for serum analysis of insulin, IGF-1, leptin, PCR, cholesterol, triglycerides leucocyte count, T lymphocyte subpopulations (T regulatory and TH17).

The hypothesis of the study is that even a short course of increased physical activity may improve quality of life of non-regular exercisers women with a personal history of breast cancer who completed treatment (endocrine treatment excluded).

Enrollment

206 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women with personal history of breast cancer AND
Written informed consent AND
Willing to be randomized to either group AND
Age 18-70 years
Treatment (surgery, chemotherapy, radiotherapy, trastuzumab) completed since at least 6 months and up to 3 years (endocrine therapy allowed)
Non regular exercisers (≤150 minutes per week of moderate-intense exercise).

Exclusion criteria

Diabetes or other insulin metabolic impairment
General contraindications to regular physical activity participation
Inability to ambulate
Plan to relocate far from the study site
Presence of any severe medical condition such that the patient is not expected to adhere at the planned study protocol