Incidence of Dysgeusia in Breast Cancer Patients Undergoing Chemotherapy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Sanitaria Locale CN2 Alba-Bra

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Taste Assessment / Nutritional Assessment / Quality of Life Assessment

    Other intervention

    Participants 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

40 Participants
are divided into 1 treatment group
Group A: Non-Metastatic Breast Cancer Patients Receiving Chemotherapy1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after the completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy

Secondary outcomes

1

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.

Time frame
- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy
2

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.

Time frame
- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy
3

Taster status assessment

Assessment of participants' "taster status" (ability to detect bitter compounds) to evaluate its potential correlation with the subsequent development of dysgeusia.

Time frame
- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy
4

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.

Time frame
- Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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