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

NCT ID: NCT07044791

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2026-02-02

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ARM A: intensive nutritional intervention

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).

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

ARM B: standard nutritional intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Grazia Arpino

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

A.O.U Federico II

Naples, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: English version

View Document

Other Identifiers

280/17

Identifier Type: -

Identifier Source: org_study_id