Life ImproVed by Exercise (LIVE Trial)

Breast Cancer Clinical Trial

— LIVE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637765
• Other study ID #: IEO 121
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: February 1, 2020

Study information

• Verified date: September 2021
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	questionnaire	8 weeks
Secondary	self-report questionaire of principal side effects of medical treatments		8 weeks
Secondary	patients' self-reported perceptions of their cognitive abilities	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
Secondary	subjective response to a specific traumatic event	administration of self-report validated questionnaire	8 weeks
Secondary	body weight	Registration of body weight at baseline and 8 weeks	8 weeks
Secondary	sleep	Registration of movements during sleep (Data registered by the pedometer device)	8 weeks
Secondary	insulin	serum analysis at baseline and 8 weeks	8 weeks
Secondary	immune function (as determined by Th17 e T regulators)	serum analysis at baseline and 8 weeks	8 weeks
Secondary	IGF-1	serum analysis at baseline and 8 weeks	8 weeks
Secondary	Leptin	serum analysis at baseline and 8 weeks	8 weeks
Secondary	C Reactive Protein	serum analysis at baseline and 8 weeks	8 weeks