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

NCT07044791 | Active Not Recruiting

• 1 other identifier: 280/17
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Cancer Invasive

Outcome Measures

Primary Outcomes (1)

• Body weight control

  To investigate the effects of an intensive nutritional intervention on Body weight control (defined as weight changes ≤+5% of the initial body weight) at 12 months after the beginning of systemic treatment.

  12 months

Secondary Outcomes (26)

• Body weight

  From enrollment to 6, 12 and 24 months

• Body Mass Index (BMI)

  From enrollment to 6, 12 and 24 months

• Body composition

  From enrollment to 6, 12 and 24 months

• Resting energy expenditure (REE)

  From enrollment to 6, 12 and 24 months

• Quality of life (QoL)

  From enrollment to 6,12 and 24 months

Study Arms (2)

ARM A: intensive nutritional intervention

EXPERIMENTAL

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).

Behavioral: Nutritional counseling. No drug treatment will be administered in this study.

ARM B: standard nutritional intervention

NO INTERVENTION

ARM B: Visits will be set up only at the baseline, after 6 months namely at the end

Interventions

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

Nutritional counseling. No drug treatment will be administered in this study.

ARM A: intensive nutritional intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥18 years old
• BMI \< 30 kg/m2
• Caucasians
• Histological diagnosis of invasive breast cancer
• Starting an adjuvant systemic treatment for breast cancer
• Available past medical history
• Informed consent to participate to the study

You may not qualify if:

• Metastatic disease
• BMI \>30 kg/m2
• Presence of a serious medical condition that could alter food absorption or prognosis
• Refusal to provide informed consent to participate in the study

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

A.O.U Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Interventional non-pharmacological study

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 1, 2025
• Study Start: February 2, 2018
• Primary Completion: October 27, 2020
• Study Completion: February 2, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)