Life ImproVed by Exercise (LIVE Trial) — LIVE  

Breast Cancer Clinical Trial

Official title: Effect of a Short Program (8 Week) of Increased Physical Activity on Quality of Life of Sedentary Women With Previous Breast Cancer. A Prospective Randomized Trial.

Status Completed

Clinical Trial Summary

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

1. Control Group of Usual Physical Activity

2. 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.

Clinical Trial Description

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

1. Control Group of Usual Physical Activity

2. 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.

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). ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02637765
• Study type: Interventional
• Source: European Institute of Oncology
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Completion date: February 1, 2020