Clinical trial · Interventional
Metabolic Parameters and Quality of Life in Women on Neo-/Adjuvant Therapy for Breast Cancer
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
NCT07044791CI-TRIAL-00091642active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Invasive | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional counseling. No drug treatment will be administered in this study. | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A: intensive nutritional intervention
- description
- 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).
- interventionNames
- Behavioral: Nutritional counseling. No drug treatment will be administered in this study.
- type
- NO_INTERVENTION
- label
- ARM B: standard nutritional intervention
- description
- ARM B: Visits will be set up only at the baseline, after 6 months namely at the end
Primary outcomes (1)
- measure
- Body weight control
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.