Life ImproVed by Exercise (LIVE Trial) (LIVE)

September 14, 2021 updated by: European Institute of Oncology

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20141
        • European Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
Usual Physical Activity
EXPERIMENTAL: Intervention Group
8-week increased physical activity program
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 8 weeks
questionnaire
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-report questionaire of principal side effects of medical treatments
Time Frame: 8 weeks
8 weeks
patients' self-reported perceptions of their cognitive abilities
Time Frame: 8 weeks
37 items consisting of 1) patients' perceived cognitive impair- ments, 2) perceived cognitive abilities, 3) noticeability or com- ments from others, and 4) impact of cognitive changes on quality of life
8 weeks
subjective response to a specific traumatic event
Time Frame: 8 weeks
administration of self-report validated questionnaire
8 weeks
body weight
Time Frame: 8 weeks
Registration of body weight at baseline and 8 weeks
8 weeks
sleep
Time Frame: 8 weeks
Registration of movements during sleep (Data registered by the pedometer device)
8 weeks
insulin
Time Frame: 8 weeks
serum analysis at baseline and 8 weeks
8 weeks
immune function (as determined by Th17 e T regulators)
Time Frame: 8 weeks
serum analysis at baseline and 8 weeks
8 weeks
IGF-1
Time Frame: 8 weeks
serum analysis at baseline and 8 weeks
8 weeks
Leptin
Time Frame: 8 weeks
serum analysis at baseline and 8 weeks
8 weeks
C Reactive Protein
Time Frame: 8 weeks
serum analysis at baseline and 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (ESTIMATE)

December 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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