Life ImproVed by Exercise (LIVE Trial)

NCT ID: NCT02637765

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2020-02-01

Brief 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.

Detailed 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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Usual Physical Activity

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

8-week increased physical activity program

Group Type: EXPERIMENTAL

Increased Physical Activity

Intervention Type: BEHAVIORAL

Patients will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks and an 8-week recreational program of brisk walking/running (3 times a week).

Interventions

Increased Physical Activity

Patients will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks and an 8-week recreational program of brisk walking/running (3 times a week).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oreste D Gentilini, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Countries

Italy

Other Identifiers

IEO 121

Identifier Type: -

Identifier Source: org_study_id