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NCT Number: NCT07317752

Incidence of Dysgeusia in Breast Cancer Patients Undergoing Chemotherapy

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

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Key information

Conditions

Taste Disorders Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy Effects Dysgeusia Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Nutritional Status Pathological Conditions, Signs and Symptoms Quality of Life Sensation Disorders Sensory Testing Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Taste Perception

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Dysgeusia, defined as an altered perception of taste, is a frequent but understudied adverse effect of several chemotherapy regimens used for the treatment of breast cancer. Taste alterations may arise from direct cytotoxic effects on taste receptor cells, changes in saliva composition, mucosal inflammation, altered signal transduction, or central nervous system effects. These disturbances can lead to reduced food enjoyment, alterations in dietary patterns, and potential deterioration of nutritional and functional status.

Although dysgeusia is commonly reported in clinical practice, estimates of its prevalence vary widely due to heterogeneous methodologies and the predominant reliance on self-reported symptoms rather than standardized sensory testing. Studies that objectively quantify changes in taste recognition thresholds during chemotherapy are limited, and little is known about specific aspects such as umami perception or chemesthetic sensitivity. Furthermore, factors that may predispose individual patients to developing dysgeusia-such as baseline taster status, nutritional condition, or specific treatment characteristics-remain poorly characterized.

This observational pilot study was designed to provide objective, reproducible data on taste function in patients with non-metastatic breast cancer receiving standard neoadjuvant or adjuvant chemotherapy. A combination of validated sensory tools, including taste strips and chemesthetic tests, is used to measure changes in taste perception over the course of treatment. Standardized methods were selected to ensure high sensitivity and repeatability and to allow quantitative comparison across different time points.

The study also integrates nutritional assessment and quality-of-life evaluation to explore the broader clinical implications of dysgeusia. Particular attention is given to potential associations between objective taste alterations, patient-reported symptoms, and parameters such as nutritional status, dietary intake, and functional well-being. Given the scarcity of comprehensive, methodologically rigorous studies in this area, the data generated may help clarify the clinical burden of dysgeusia and inform strategies to mitigate its impact on patients undergoing chemotherapy for breast cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)
  • Signed written informed consent

Exclusion criteria

  • 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
  • Lack of signed written informed consent

Treatment and study plan

Taste Assessment / Nutritional Assessment / Quality of Life Assessment

Other

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.

Primary outcomes

  1. Incidence of dysgeusia during 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 the completion of chemotherapy - Follow-up: 2 months after the end of 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

  1. Quantitative changes in taste recognition thresholds

    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

    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.

  2. Chemesthetic sensitivity assessed by capsaicin strips

    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

    Evaluation of chemesthetic function using strips impregnated with capsaicin at four increasing concentrations to assess oral sensitivity to chemical stimuli.

  3. Taster status assessment

    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

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

  4. Chemotherapy-induced taste alteration (CiTAS) questionnaire

    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

    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.

  5. Nutritional status assessment

    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

    Evaluation of nutritional status using the Global Leadership Initiative on Malnutrition (GLIM) criteria and measurement of phase angle using bioelectrical impedance analysis (BIA).

  6. Caloric and macronutrient intake

    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

    Assessment of caloric and macronutrient intake using 24-hour dietary recall interviews to determine changes during and after chemotherapy.

  7. Quality of life assessment (FACT-G)

    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

    Evaluation of quality of life using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire.

    The total score is derived by summing scores from four domains (physical, social/family, emotional, and functional well-being). Each item is scored on a 5-point scale from 0 ("Not at all") to 4 ("Very much").

Study contacts

Contact information is provided by the study sponsor or research team.

Cloè Dalla Costa, MD

CONTACT

[email protected]

+39.0172.1408493

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale CN2 Alba-Bra

Other

Registry information

Official study title

Incidenza Della Disgeusia Nei Pazienti Affetti da Carcinoma Mammario in Trattamento Chemioterapico: Uno Studio Pilota Prospettico

Acronym: GustiAmo

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

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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