Condition category
Cancer
Date applied
03/07/2016
Date assigned
09/07/2016
Last edited
07/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Its common for women having chemotherapy and antiestrogenic treatment for breast cancer to gain weight. This can increase the risk of the cancer coming back and death due to the fact that they can aggravate insulin and leptin (a hormone produced by the body’s fat cells) resistance, , as well as dysbiosis (a term used to describe microbial imbalance in the gut) and dyslipidemia (increase through osteosarcopenia. Also, the emotional impact of either conservative surgery or mastectomy can theoretically influence these patients’ eating behavior and willingness to exercise in order to reverse this weight gain. This home-based study aims to answer three questions:
1. Is a high protein diet effective for fat loss in ER+ breast cancer patients on antiestrogenic medication?
2. Is the addition of only 4 minutes of daily isometric exercises to this high protein diet more effective to improve their body composition?
3. How does the surgery, chemotherapy and antiestrogenic medication type influences the effects of these interventions?

Who can participate?
Overweight women with breast cancer who are currently being treated with antiestrogenic treatment after surgery and chemotherapy

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 follow an at home diet based on food rich in protein, calcium, omega-3 fatty acids, probiotics and prebiotics for one year. Those in group 2 follow the same diet but also do 4’ isometric exercises for one year. All participants have their total body weight, body fat and visceral fat (belly fat) six months into the study and again at the end of the study (one year).

What are the possible benefits and risks of participating?
The diet was made up of easily affordable foods and the exercises were highly accepted. It is hoped that these will led to an improvement in body composition and general wellbeing. All participants were closely supervised for the first two months of the study so that any associated risk of taking part would be reduced to minimum.

Where is the study run from?
”Prof. Dr. Al. Trestioreanu” Institute of Oncology (Romania)

When is the study starting and how long is it expected to run for?
February 2915 to April 2016

Who is funding the study?
European Social Fund

Who is the main contact?
Mrs Diana Viorela Arterne

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Diana Viorela Artene

ORCID ID

http://orcid.org/0000-0002-7910-9572

Contact details

Ficusului street no. 1
vila 80
Balotesti
077010
Romania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Comparative results of 1-year at home diet and exercise interventions in ER+ breast cancer patients correlated with treatment type

Acronym

Study hypothesis

This home-based study aims to answer three questions:
1. Is a high protein diet effective for fat loss in ER+ breast cancer patients on antiestrogenic medication?
2. Is the addition of only 4 minutes of daily isometric exercises to this high protein diet more effective to improve their body composition?
3. How does the surgery, chemotherapy and antiestrogenic medication type influences the effects of these interventions?

Ethics approval

Ethics Committee of the ”Prof. Dr. Al. Trestioreanu” Institute of Oncology, Bucharest, Romania, ref: 4555/18.03.2016.

Study design

Single center interventional randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

ER+/PR±/HER2- breast cancer

Intervention

Overweight patients with ER+/PR±/HER2- luminal A and B breast cancer, currently under antiestrogenic treatment after surgery and chemotherapy - without diabetes, thyroid or renal disease, eating disorders, depression and osteoporosis were selected for this study. They were randomly allocated into one of two groups.
1. Participants follow an at home diet based on food high in proteins, calcium, omega-3 fatty acids, probiotics and prebiotics (D) for one year
2. Participants follow the same diet as those in group 1 in combination with 4’ isometric exercises (D+Ex) for one year
Total body weight, body and and visceral fat were measured for all participants using a multi-frequency bioelectrical impedance scale after 6 months and after 12 months. The results were then correlated with the study intervention and with the type of antiestrogenic medication, surgery and chemotherapy.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Total body weight, body and and visceral fat using a multi-frequency bioelectrical impedance scale at 6 months and 12 months

Secondary outcome measures

N/A

Overall trial start date

01/02/2015

Overall trial end date

01/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Overweight patients with ER+/PR±/HER2- luminal A and B breast cancer
2. Currently under antiestrogenic treatment after surgery and chemotherapy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

165 patients: 83 in the Diet intervention group and 82 in the D+Ex intervention group

Participant exclusion criteria

1. Diabetes
2. Thyroid or renal disease
3. Eating disorders
4. Depression
5. Osteoporosis

Recruitment start date

01/02/2015

Recruitment end date

15/02/2015

Locations

Countries of recruitment

Romania

Trial participating centre

”Prof. Dr. Al. Trestioreanu” Institute of Oncology
Șoseaua Fundeni 252
Bucharest
022328
Romania

Sponsor information

Organisation

Carol Davila Medicine University

Sponsor details

Dionisie Lupu Street no.37
District 2
Bucharest
020021
Romania

Sponsor type

University/education

Website

http://www.umf.ro

Funders

Funder type

Government

Funder name

European Social Fund

Alternative name(s)

Fonds Social Européen, Europäische Sozialfonds, Fondo Social Europeo, Fonds Social Européen, Europäische Sozialfonds, ESF

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/04/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes