ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	11 February 2019
Main ID:	ISRCTN12929438
Date of registration:	09/07/2016
Prospective Registration:	No
Primary sponsor:	Carol Davila Medicine University
Public title:	1-year at home diet and exercise interventions in ER+ breast cancer patients
Scientific title:	Comparative results of 1-year at home diet and exercise interventions in ER+ breast cancer patients correlated with treatment type
Date of first enrolment:	01/02/2015
Target sample size:	165
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN12929438
Study type:	Interventional
Study design:	Single center interventional randomised parallel trial (Prevention)
Phase:

Countries of recruitment
Romania

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Diana Viorela Artene
Address:	Ficusului street no. 1 vila 80 077010 Balotesti Romania
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

ER+/PR±/HER2- breast cancer
Cancer

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

European Social Fund

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	01/04/2016
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.