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Life ImproVed by Exercise (LIVE Trial) (LIVE)

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ClinicalTrials.gov Identifier: NCT02637765
Recruitment Status : Unknown
Verified August 2016 by European Institute of Oncology.
Recruitment status was:  Recruiting
First Posted : December 22, 2015
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Increased Physical Activity Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. quality of life [ Time Frame: 8 weeks ]
    questionnaire


Secondary Outcome Measures :
  1. self-report questionaire of principal side effects of medical treatments [ Time Frame: 8 weeks ]
  2. 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

  3. subjective response to a specific traumatic event [ Time Frame: 8 weeks ]
    administration of self-report validated questionnaire

  4. body weight [ Time Frame: 8 weeks ]
    Registration of body weight at baseline and 8 weeks

  5. sleep [ Time Frame: 8 weeks ]
    Registration of movements during sleep (Data registered by the pedometer device)

  6. insulin [ Time Frame: 8 weeks ]
    serum analysis at baseline and 8 weeks

  7. immune function (as determined by Th17 e T regulators) [ Time Frame: 8 weeks ]
    serum analysis at baseline and 8 weeks

  8. IGF-1 [ Time Frame: 8 weeks ]
    serum analysis at baseline and 8 weeks

  9. Leptin [ Time Frame: 8 weeks ]
    serum analysis at baseline and 8 weeks

  10. PCR [ Time Frame: 8 weeks ]
    serum analysis at baseline and 8 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637765


Contacts
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Contact: Claudia Sangalli, Ms +390257489840 claudia.sangalli@ieo.it

Locations
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Italy
European Institute of Oncology Recruiting
Milan, Italy, 20141
Principal Investigator: Gabriella Pravettoni         
Sub-Investigator: Ketty Mazzocco         
Sponsors and Collaborators
European Institute of Oncology
Investigators
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Principal Investigator: Oreste D Gentilini, MD European Institute of Oncology

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Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT02637765     History of Changes
Other Study ID Numbers: IEO 121
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by European Institute of Oncology:
Breast Cancer
Physical Activity
Quality of life

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases