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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional counseling. No drug treatment will be administered in this study. | Behavioral | Nutritional counseling. No drug treatment will be administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to 6, 12 and 24 months |
| Body Mass Index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U Federico II | Naples | 80131 | Italy |
Past medical history, clinico-pathological informations, anthropometric variables, survival status.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2017 | May 29, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: English version | Oct 10, 2017 | Jun 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Interventional non-pharmacological study
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Body Mass Index (BMI)
Kg/m2
| 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. | 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. | 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. | 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) | 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) | From enrollment to 6,12 and 24 months |
| Change from Baseline in the Mean concentration of C-peptide (ng/ml) | Serum metabolic variables (concentration)
| From enrollment to 6,12 and 24 months |
| Change from Baseline in the Mean concentration of glycosylated haemoglobin | Serum metabolic variables (concentration)
| From enrollment to 6,12 and 24 months |
| Change from Baseline in the Mean concentration of total cholesterol | Serum metabolic variables (concentration)
| 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) | 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) | From enrollment to 6,12 and 24 months |
| Change from Baseline in the Mean concentration of triglycerides | Serum metabolic variables (concentration) -triglycerides (mg/dl) | From enrollment to 6,12 and 24 months |
| Change from Baseline in the Mean concentration of urea | Serum metabolic variables (concentration) -urea (mg/dl) | From enrollment to 6,12 and 24 months |
| Change from Baseline in the Mean concentration of creatinine | Serum metabolic variables (concentration) -creatinine (mg/dl) | From enrollment to 6,12 and 24 months |
| Change from Baseline in the Mean concentration of urate | Serum metabolic variables (concentration) -urate (mg/dl) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | From enrollment to 6,12 and 24 months |
| D017437 |
| Skin and Connective Tissue Diseases |