An interventional study of Nutritional counseling. No drug treatment will be administered in this study. in Breast Cancer and Breast Cancer Invasive, sponsored by Federico II University. Active, not recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Federico II University · Not applicable, Interventional, and Supportive care
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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: Visits will be set up only at the baseline, after 6 months namely at the end
Nutritional counseling. No drug treatment will be administered in this study.
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.
Time frame: 12 months
Body weight
To evaluate the effects of an intensive nutritional intervention at 6, 12 and 24 months after the beginning of systemic treatment on: \- Body weight (Kg)
Time frame: From enrollment to 6, 12 and 24 months
Body Mass Index (BMI)
Body Mass Index (BMI) Kg/m2
Time frame: From enrollment to 6, 12 and 24 months
Body composition
Body composition Body composition will be assessed with Bio-impedance analysis (BIA) at 50 kilohertz (kHz) (Human Im Plus II, Medica) at room temperature of 22-25 °C.
Time frame: From enrollment to 6, 12 and 24 months
Resting energy expenditure (REE)
Resting energy expenditure (REE) Resting Energy Expenditure will be measured (MREE) by indirect calorimetry using a canopy system (V max29, Sensor Medics, U.S.A.) at an ambient temperature of 23-25 °C.
Time frame: From enrollment to 6, 12 and 24 months
Quality of life (QoL)
Quality of life (QoL) Assessed with European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 (version 3.0) The EORTC QLQ-C30 questionnaire yields scores ranging from 0 to 100 for each domain. For functional scales and the global health status/QoL scale, higher scores indicate better functioning or quality of life, meaning a higher score represents a better outcome. In contrast, for symptom scales and single items (e.g., fatigue, pain, nausea), higher scores indicate more severe symptoms, meaning a higher score reflects a worse outcome.
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Fasting glucose
Serum metabolic variables (concentration) -Fasting glucose (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Serum insulin (mg/dl)
Serum metabolic variables (concentration) -serum insulin concentration (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of C-peptide (ng/ml)
Serum metabolic variables (concentration) * C-peptide (ng/ml)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of glycosylated haemoglobin
Serum metabolic variables (concentration) * glycosylated haemoglobin (%)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of total cholesterol
Serum metabolic variables (concentration) * total cholesterol (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of HDL cholesterol
Serum metabolic variables (concentration) -HDL cholesterol (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of LDL cholesterol
Serum metabolic variables (concentration) -LDL cholesterol (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of triglycerides
Serum metabolic variables (concentration) -triglycerides (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of urea
Serum metabolic variables (concentration) -urea (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of creatinine
Serum metabolic variables (concentration) -creatinine (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of urate
Serum metabolic variables (concentration) -urate (mg/dl)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Aspartate Amino Transaminase
Serum metabolic variables (concentration) \- Aspartate Amino Transaminase (AST) (U/L)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Alanine AminoTransferase
Serum metabolic variables (concentration) \- Alanine AminoTransferase (ALT) (U/L)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Gamma-Glutamyl Transferase
Serum metabolic variables (concentration) -Gamma-Glutamyl Transferase (GGT) (U/L)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Alkaline Phosphatase
Serum metabolic variables (concentration) \- Alkaline Phosphatase (ALP) (U/L)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of erythrocytes Sedimentation Rate
Serum metabolic variables (concentration) \- Erythrocyte Sedimentation Rate (ESR) (U/L)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of C-reactive protein
Serum metabolic variables (concentration) -C-reactive protein (PCR) (U/L)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Thyroid-stimulating hormone
Serum metabolic variables (concentration) -Thyroid-stimulating hormone (TSH) (mUI/L)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Free Triiodothyronine
Serum metabolic variables (concentration) -Free Triiodothyronine (FT3) (pg/ml)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of Free thyroxine
Serum metabolic variables (concentration) -Free thyroxine (FT4) (pg/ml)
Time frame: From enrollment to 6,12 and 24 months
Change from Baseline in the Mean concentration of vitamin D
Serum metabolic variables (concentration) -vitamin D (ng/ml)
Time frame: From enrollment to 6,12 and 24 months
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Plan to share: Yes — Past medical history, clinico-pathological informations, anthropometric variables, survival status.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Federico II University