NCT07044791

Metabolic Parameters and Quality of Life in Women on Neo-/Adjuvant Therapy for Breast Cancer

Metabolic Parameters and Quality of Life in Women on Neo-/Adjuvant Therapy for Breast Cancer: a Randomized Controlled Trial on the Effectiveness of an Intensive Dietary Intervention

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present trial aims to compare the effectiveness of an "intensive" vs a "standard" nutritional intervention on body weight regulation and some metabolic parameters in women on adjuvant/neoadjuvant therapy for breast cancer.

Detailed description

The effectiveness of an "intensive" versus "non-intensive" dietary intervention will be assessed in 120 patients on adjuvant therapy for breast cancer (BC) in a prospective, randomized controlled study for a total of 3 years. The eligibility of participants will be verified according to the inclusion/exclusion criteria at the screening visit; therefore, after a detailed explanation of the study protocol, Informed Consent will be signed. After the recruitment, subjects will be randomized into an "intensive" (ARM A) and "non-intensive" (ARM B) dietary intervention group. After the 6 month treatment period, patients will be followed up for the following 18 months. ARM A: Visits will be set up monthly in order to assess body weight, waist circumference, diet compliance (etc...) for all period of the BC adjuvant treatment (6 months). ARM B: Visits will be set up only at the baseline, after 6 months namely at the end. No drug treatment will be given to patients during the trial.

Conditions

• Breast Cancer
• Breast Cancer Invasive

Interventions

Type	Name	Description
BEHAVIORAL	Nutritional counseling. No drug treatment will be administered in this study.	Nutritional counseling. No drug treatment will be administered in this study.

Timeline

• Start date: 2018-02-02
• Primary completion: 2020-10-27
• Completion: 2026-02-02
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: Italy