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Breast CancerNCT07044791

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

A study testing Nutritional counseling. No drug treatment will be administered in this study. in people with Breast Cancer and Breast Cancer Invasive, run by Federico II University at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Breast Cancer Invasive
What is being tested?
Nutritional counseling. No drug treatment will be administered in this study.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteItaly
Study dates
2 Feb 2018to 2 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • A.O.U Federico II

    Naples, 80131

Other trials in Italy

About this study

Official 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

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.

Read the 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.

Being tested
Nutritional counseling. No drug treatment will be administered in this study.
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT07044791
Study groupRoleWhat they receive
ARM A: intensive nutritional interventionExperimentalARM 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).
Receives: Behavioral: Nutritional counseling. No drug treatment will be administered in this study.
ARM B: standard nutritional interventionNo interventionARM B: Visits will be set up only at the baseline, after 6 months namely at the end

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (26)

  1. 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)

    Measured: From enrollment to 6, 12 and 24 months

  2. Body Mass Index (BMI)

    Body Mass Index (BMI)

    Kg/m2

    Measured: From enrollment to 6, 12 and 24 months

  3. 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.

    Measured: From enrollment to 6, 12 and 24 months

  4. 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.

    Measured: From enrollment to 6, 12 and 24 months

  5. 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.

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    -Fasting glucose (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    -serum insulin concentration (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    • C-peptide (ng/ml)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    • glycosylated haemoglobin (%)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    • total cholesterol (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    -HDL cholesterol (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    -LDL cholesterol (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

  13. Change from Baseline in the Mean concentration of triglycerides

    Serum metabolic variables (concentration)

    -triglycerides (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

  14. Change from Baseline in the Mean concentration of urea

    Serum metabolic variables (concentration)

    -urea (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

  15. Change from Baseline in the Mean concentration of creatinine

    Serum metabolic variables (concentration)

    -creatinine (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

  16. Change from Baseline in the Mean concentration of urate

    Serum metabolic variables (concentration)

    -urate (mg/dl)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

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

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    • Alanine AminoTransferase (ALT) (U/L)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

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

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    • Alkaline Phosphatase (ALP) (U/L)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

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

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

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

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

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

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    -Free Triiodothyronine (FT3) (pg/ml)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    -Free thyroxine (FT4) (pg/ml)

    Measured: From enrollment to 6,12 and 24 months

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

    Serum metabolic variables (concentration)

    -vitamin D (ng/ml)

    Measured: From enrollment to 6,12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start2 Feb 2018
  3. Primary completion27 Oct 2020
  4. Study completion2 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Interventional non-pharmacological study
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07044791
Sponsor's protocol ID
280/17
Status last verified
Jun 2025
First submitted
30 May 2025
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Past medical history, clinico-pathological informations, anthropometric variables, survival status.

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional counseling. No drug treatment will be administered in this study. in people with Breast Cancer and Breast Cancer Invasive, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight control (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07044791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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