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

Federico II University

Status: Active, not recruiting

Conditions: Breast Cancer; Breast Cancer Invasive

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07044791

280/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

ARM A: intensive nutritional intervention

Experimental group

Description:

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).

Treatment:

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

ARM B: standard nutritional intervention

No Intervention group

Description:

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