Breast CancerLIVENCT02637765
Life ImproVed by Exercise (LIVE Trial)
A study testing Increased Physical Activity in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Increased Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2014to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
This is a prospective randomized controlled trial in which patients with previous breast cancer will be randomized into two treatment arms:
- Control Group of Usual Physical Activity
- Intervention Group of Increased Physical Activity
Read more
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.
Read the detailed description
In this prospective randomized controlled trial patients with previous breast cancer will be randomized into two treatment arms:
- Control Group of Usual Physical Activity
- 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
- Being tested
- Increased Physical Activity
- Keywords
- Breast Cancer, Physical Activity, Quality of life
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased Physical ActivityBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Usual Physical Activity |
| Intervention Group | Experimental | 8-week increased physical activity program Receives: Behavioral: Increased Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
questionnaire
Measured: 8 weeks
Secondary outcomes (10)
self-report questionaire of principal side effects of medical treatments
Measured: 8 weeks
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
Measured: 8 weeks
subjective response to a specific traumatic event
administration of self-report validated questionnaire
Measured: 8 weeks
body weight
Registration of body weight at baseline and 8 weeks
Measured: 8 weeks
sleep
Registration of movements during sleep (Data registered by the pedometer device)
Measured: 8 weeks
insulin
serum analysis at baseline and 8 weeks
Measured: 8 weeks
immune function (as determined by Th17 e T regulators)
serum analysis at baseline and 8 weeks
Measured: 8 weeks
IGF-1
serum analysis at baseline and 8 weeks
Measured: 8 weeks
Leptin
serum analysis at baseline and 8 weeks
Measured: 8 weeks
C Reactive Protein
serum analysis at baseline and 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJul 2014
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oreste D Gentilini, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637765
- Sponsor's protocol ID
- IEO 121
- Acronym
- LIVE
- Status last verified
- Sep 2021
- First submitted
- 19 Jun 2015
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02637765
- Acronym / sponsor ID
- LIVE / IEO 121
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Physical Activity, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized controlled trial in which patients with previous breast cancer will be randomized into two treatment arms:
- Control Group of Usual Physical Activity
- 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:
- Control Group of Usual Physical Activity
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Usual Physical Activity |
| Intervention Group | Experimental | Behavioral: Increased Physical Activity8-week increased physical activity program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased Physical ActivityPatients 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). | Behavioural | Intervention Group |
Primary outcome
quality of life
Time frame: 8 weeks
questionnaire
10 secondary outcomes
self-report questionaire of principal side effects of medical treatments
Time frame: 8 weeks
patients' self-reported perceptions of their cognitive abilities
Time frame: 8 weeks
subjective response to a specific traumatic event
Time frame: 8 weeks
body weight
Time frame: 8 weeks
sleep
Time frame: 8 weeks
insulin
Time frame: 8 weeks
immune function (as determined by Th17 e T regulators)
Time frame: 8 weeks
IGF-1
Time frame: 8 weeks
Leptin
Time frame: 8 weeks
C Reactive Protein
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oreste D Gentilini, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased Physical Activity in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.