Clinical trial NCT02637765: Life ImproVed by Exercise (LIVE 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Physical Activity
Quality of life
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: quality of life
timeFrame: 8 weeks
Secondary outcomes:
measure: self-report questionaire of principal side effects of medical treatments
timeFrame: 8 weeks
measure: patients' self-reported perceptions of their cognitive abilities
timeFrame: 8 weeks
measure: subjective response to a specific traumatic event
timeFrame: 8 weeks
measure: body weight
timeFrame: 8 weeks
measure: sleep
timeFrame: 8 weeks
measure: insulin
timeFrame: 8 weeks
measure: immune function (as determined by Th17 e T regulators)
timeFrame: 8 weeks
measure: IGF-1
timeFrame: 8 weeks
measure: Leptin
timeFrame: 8 weeks
measure: C Reactive Protein
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Oreste D Gentilini, MD
role: PRINCIPAL_INVESTIGATOR
References: