About this trial
The goal of this observational study is to examine how frequently changes in taste occur in people with early-stage breast cancer who receive chemotherapy. It will also look at how these taste changes affect nutrition and quality of life. The main questions this study aims to answer are:
* How many participants develop changes in taste during chemotherapy? * How do these changes affect eating habits, nutrition, and daily life?
Participants are women with non-metastatic breast cancer who are receiving chemotherapy before or after surgery.
Researchers will use standardized taste tests to measure how well participants can perceive different flavors. These tests are designed to provide accurate and reproducible results.
Participants will:
* Take part in taste tests during their chemotherapy treatment * Have their nutritional status evaluated * Answer questions about their quality of life
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Diagnosis of non-metastatic breast cancer
Indication for neoadjuvant or adjuvant chemotherapy as part of standard clinical practice
Chemotherapy-naïve patients (no chemotherapy received in the previous 12 months)
Disqualifiers
Terminal or metastatic disease
Pre-existing taste or smell disorders (e.g., anosmia, dysgeusia, neurological syndromes, etc.)
Known allergies to any substances used in taste and chemesthetic function tests (e.g., quinine dihydrochloride, monosodium L-glutamate, capsaicin, etc.)
Receiving neoadjuvant or adjuvant chemotherapy within research protocols
Trial population
This group includes male and female participants diagnosed with non-metastatic breast cancer who are receiving neoadjuvant or adjuvant chemotherapy according to standard clinical practice. Participants are treated at the Oncology Unit of Michele and Pietro Ferrero Hospital in Verduno. Eligible participants are those for whom chemotherapy is indicated as part of their routine care, and who are willing and able to complete sensory tests, nutritional assessments, and quality of life questionnaires during the study period.
Trial design
Case-control
Prospective
Treatments tested in this trial
Taste Assessment / Nutritional Assessment / Quality of Life Assessment
Other interventionParticipants will undergo additional procedures as part of the study to assess taste function, nutritional status, and quality of life. These procedures include: * Taste assessment using standardized taste strips to measure recognition thresholds for the five basic tastes (sweet, sour, salty, bitter, umami) and chemesthetic sensitivity using strips impregnated with capsaicin. * Questionnaires to evaluate chemotherapy-induced taste alterations (CiTAS) and general quality of life (FACT-G). * Nutritional assessment, including evaluation of caloric and macronutrient intake using 24-hour dietary recalls, assessment of nutritional status according to GLIM criteria, and measurement of phase angle through bioelectrical impedance analysis (BIA). All procedures are non-invasive and performed in addition to the participants' standard chemotherapy treatment.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of dysgeusia during chemotherapy
The primary endpoint is the incidence of dysgeusia after the start of chemotherapy in participants with non-metastatic breast cancer. Taste perception will be evaluated using standardized taste strips to determine recognition thresholds for four basic tastes (sweet, sour, salty, and bitter). Dysgeusia will be considered present if the total taste strip score is lower than 9 at any of the evaluated time points.
Secondary outcomes
Quantitative changes in taste recognition thresholds
Quantitative evaluation of recognition thresholds for the five basic tastes (sweet, sour, salty, bitter, and umami) to assess changes in taste perception during and after chemotherapy.
Chemesthetic sensitivity assessed by capsaicin strips
Evaluation of chemesthetic function using strips impregnated with capsaicin at four increasing concentrations to assess oral sensitivity to chemical stimuli.
Taster status assessment
Assessment of participants' "taster status" (ability to detect bitter compounds) to evaluate its potential correlation with the subsequent development of dysgeusia.
Chemotherapy-induced taste alteration (CiTAS) questionnaire
Evaluation of participant-reported taste alterations using the Chemotherapy-Induced Taste Alteration Scale (CiTAS) and comparison with objective sensory test findings. Score range: 1 to 5. Higher scores indicate more severe taste alterations.
Locations
Sponsors and contacts
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