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NCT Number: NCT07044791

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Cancer Invasive Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

A.O.U Federico II

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. Body weight control

    Time frame: 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 outcomes

  1. Body weight

    Time frame: 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)

  2. Body Mass Index (BMI)

    Time frame: From enrollment to 6, 12 and 24 months

    Body Mass Index (BMI)

    Kg/m2

  3. Body composition

    Time frame: 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.

  4. Resting energy expenditure (REE)

    Time frame: 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.

  5. Quality of life (QoL)

    Time frame: 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.

  6. Change from Baseline in the Mean concentration of Fasting glucose

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -Fasting glucose (mg/dl)

  7. Change from Baseline in the Mean concentration of Serum insulin (mg/dl)

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -serum insulin concentration (mg/dl)

  8. Change from Baseline in the Mean concentration of C-peptide (ng/ml)

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    • C-peptide (ng/ml)

  9. Change from Baseline in the Mean concentration of glycosylated haemoglobin

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    • glycosylated haemoglobin (%)

  10. Change from Baseline in the Mean concentration of total cholesterol

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    • total cholesterol (mg/dl)

  11. Change from Baseline in the Mean concentration of HDL cholesterol

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -HDL cholesterol (mg/dl)

  12. Change from Baseline in the Mean concentration of LDL cholesterol

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -LDL cholesterol (mg/dl)

  13. Change from Baseline in the Mean concentration of triglycerides

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -triglycerides (mg/dl)

  14. Change from Baseline in the Mean concentration of urea

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -urea (mg/dl)

  15. Change from Baseline in the Mean concentration of creatinine

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -creatinine (mg/dl)

  16. Change from Baseline in the Mean concentration of urate

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -urate (mg/dl)

  17. Change from Baseline in the Mean concentration of Aspartate Amino Transaminase

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    • Aspartate Amino Transaminase (AST) (U/L)

  18. Change from Baseline in the Mean concentration of Alanine AminoTransferase

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    • Alanine AminoTransferase (ALT) (U/L)

  19. Change from Baseline in the Mean concentration of Gamma-Glutamyl Transferase

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -Gamma-Glutamyl Transferase (GGT) (U/L)

  20. Change from Baseline in the Mean concentration of Alkaline Phosphatase

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    • Alkaline Phosphatase (ALP) (U/L)

  21. Change from Baseline in the Mean concentration of erythrocytes Sedimentation Rate

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    • Erythrocyte Sedimentation Rate (ESR) (U/L)

  22. Change from Baseline in the Mean concentration of C-reactive protein

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -C-reactive protein (PCR) (U/L)

  23. Change from Baseline in the Mean concentration of Thyroid-stimulating hormone

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -Thyroid-stimulating hormone (TSH) (mUI/L)

  24. Change from Baseline in the Mean concentration of Free Triiodothyronine

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -Free Triiodothyronine (FT3) (pg/ml)

  25. Change from Baseline in the Mean concentration of Free thyroxine

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -Free thyroxine (FT4) (pg/ml)

  26. Change from Baseline in the Mean concentration of vitamin D

    Time frame: From enrollment to 6,12 and 24 months

    Serum metabolic variables (concentration)

    -vitamin D (ng/ml)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Metabolic Parameters and Quality of Life in Women on Neo-/Adjuvant Therapy for Breast Cancer: a Randomized Controlled Trial on the Effectiveness of an Intensive Dietary Intervention

Important dates

Study start
2018
Primary completion
2020
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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