Breast Cancer, Breast Cancer Invasive
Conditions
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.
Interventions
BEHAVIORALNutritional counseling. No drug treatment will be administered in this study.
Nutritional counseling. No drug treatment will be administered in this study.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Interventional non-pharmacological study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight control | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | From enrollment to 6, 12 and 24 months | Body Mass Index (BMI) Kg/m2 |
| Body composition | From enrollment to 6, 12 and 24 months | 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. |
| Resting energy expenditure (REE) | From enrollment to 6, 12 and 24 months | 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. |
| Quality of life (QoL) | From enrollment to 6,12 and 24 months | 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. |
| Change from Baseline in the Mean concentration of Fasting glucose | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -Fasting glucose (mg/dl) |
| Change from Baseline in the Mean concentration of Serum insulin (mg/dl) | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -serum insulin concentration (mg/dl) |
| Change from Baseline in the Mean concentration of C-peptide (ng/ml) | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) * C-peptide (ng/ml) |
| Change from Baseline in the Mean concentration of glycosylated haemoglobin | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) * glycosylated haemoglobin (%) |
| Change from Baseline in the Mean concentration of total cholesterol | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) * total cholesterol (mg/dl) |
| Change from Baseline in the Mean concentration of HDL cholesterol | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -HDL cholesterol (mg/dl) |
| Change from Baseline in the Mean concentration of LDL cholesterol | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -LDL cholesterol (mg/dl) |
| Change from Baseline in the Mean concentration of triglycerides | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -triglycerides (mg/dl) |
| Body weight | From enrollment to 6, 12 and 24 months | 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) |
| Change from Baseline in the Mean concentration of creatinine | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -creatinine (mg/dl) |
| Change from Baseline in the Mean concentration of urate | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -urate (mg/dl) |
| Change from Baseline in the Mean concentration of Aspartate Amino Transaminase | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) \- Aspartate Amino Transaminase (AST) (U/L) |
| Change from Baseline in the Mean concentration of Alanine AminoTransferase | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) \- Alanine AminoTransferase (ALT) (U/L) |
| Change from Baseline in the Mean concentration of Gamma-Glutamyl Transferase | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -Gamma-Glutamyl Transferase (GGT) (U/L) |
| Change from Baseline in the Mean concentration of Alkaline Phosphatase | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) \- Alkaline Phosphatase (ALP) (U/L) |
| Change from Baseline in the Mean concentration of erythrocytes Sedimentation Rate | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) \- Erythrocyte Sedimentation Rate (ESR) (U/L) |
| Change from Baseline in the Mean concentration of C-reactive protein | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -C-reactive protein (PCR) (U/L) |
| Change from Baseline in the Mean concentration of Thyroid-stimulating hormone | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -Thyroid-stimulating hormone (TSH) (mUI/L) |
| Change from Baseline in the Mean concentration of Free Triiodothyronine | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -Free Triiodothyronine (FT3) (pg/ml) |
| Change from Baseline in the Mean concentration of Free thyroxine | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -Free thyroxine (FT4) (pg/ml) |
| Change from Baseline in the Mean concentration of vitamin D | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -vitamin D (ng/ml) |
| Change from Baseline in the Mean concentration of urea | From enrollment to 6,12 and 24 months | Serum metabolic variables (concentration) -urea (mg/dl) |
Countries
Italy
Outcome results
None listed