A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.

Breast Cancer Clinical Trial

Official title:

A Standardized Integral Nutritional Intervention 1 and Physical Activity Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980118
• Other study ID #: HULP 3114
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: August 2019
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.

Description:

56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain. A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures was conducted by physicians of the Nutrition Unit during one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Years: =18
• Sex: Female
• Newly diagnosed breast cáncer

Exclusion Criteria:

• Patients who have disseminated disease.
• Associated eating behavior disorders.
• Patients with dementia, mental illness or decreased cognitive function.
• Consumption of drugs or substances to lose weight (except in those cases in which it is suspended 15 days before starting the study).
• Presence of disease that may interfere with weight loss: severe psychiatric illness, uncontrolled hypothyroidism.
• Pregnant or breastfeeding women.

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Breast Cancer
• Breast Neoplasms
• Nutrition Related Cancer
• Weight Loss

Intervention

Behavioral:
• Control group
A nutritional intervention program that consisted of two individual nutritional consults.
• Nutrition and physical activity group
A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.

Locations

Country	Name	City	State
Spain	Institute for Health Research IdiPAZ	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.	To examine the frequency of food consumption	Six months