Incidence of Dysgeusia in Breast Cancer Patients Undergoing Chemotherapy (GustiAmo)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Breast Cancer; Nutritional Status; Taste Disorders; Dysgeusia; Chemotherapy Effects; Taste Perception; Sensory Testing
• Intervention / Treatment: Other: Taste Assessment / Nutritional Assessment / Quality of Life Assessment

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Cloè Dalla Costa, MD; Phone Number: +39.0172.1408493; Email: cdallacosta@aslcn2.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Non-Metastatic Breast Cancer Patients Receiving Chemotherapy; 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. All 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 routine care and who are willing and able to complete sensory tests, nutritional assessments, and quality-of-life questionnaires during the study period.

Other: Taste Assessment / Nutritional Assessment / Quality of Life Assessment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	- 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	- 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
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.	- 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
Taster status assessment	Assessment of participants' "taster status" (ability to detect bitter compounds) to evaluate its potential correlation with the subsequent development of dysgeusia.	- 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
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.	- 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
Nutritional status assessment	Evaluation of nutritional status using the Global Leadership Initiative on Malnutrition (GLIM) criteria and measurement of phase angle using bioelectrical impedance analysis (BIA).	- 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
Caloric and macronutrient intake	Assessment of caloric and macronutrient intake using 24-hour dietary recall interviews to determine changes during and after chemotherapy.	- 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
Quality of life assessment (FACT-G)	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").	- 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

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale CN2 Alba-Bra

Publications and helpful links

General Publications

• Mueller C, Kallert S, Renner B, Stiassny K, Temmel AF, Hummel T, Kobal G. Quantitative assessment of gustatory function in a clinical context using impregnated "taste strips". Rhinology. 2003 Mar;41(1):2-6.
• Buttiron Webber T, Briata IM, DeCensi A, Cevasco I, Paleari L. Taste and Smell Disorders in Cancer Treatment: Results from an Integrative Rapid Systematic Review. Int J Mol Sci. 2023 Jan 28;24(3):2538. doi: 10.3390/ijms24032538.
• Sawicki CM, Janal MN, Nicholson SJ, Wu AK, Schmidt BL, Albertson DG. Oral cancer patients experience mechanical and chemical sensitivity at the site of the cancer. BMC Cancer. 2022 Nov 11;22(1):1165. doi: 10.1186/s12885-022-10282-3.
• Turcott JG, Juarez-Hernandez E, De la Torre-Vallejo M, Sanchez-Lara K, Luvian-Morales J, Arrieta O. Value: Changes in the Detection and Recognition Thresholds of Three Basic Tastes in Lung Cancer Patients Receiving Cisplatin and Paclitaxel and Its Association with Nutritional and Quality of Life Parameters. Nutr Cancer. 2016;68(2):241-9. doi: 10.1080/01635581.2016.1144075. Epub 2016 Mar 4.
• Epstein JB, de Andrade E Silva SM, Epstein GL, Leal JHS, Barasch A, Smutzer G. Taste disorders following cancer treatment: report of a case series. Support Care Cancer. 2019 Dec;27(12):4587-4595. doi: 10.1007/s00520-019-04758-5. Epub 2019 Mar 29.
• Nolden AA, Hwang LD, Boltong A, Reed DR. Chemosensory Changes from Cancer Treatment and Their Effects on Patients' Food Behavior: A Scoping Review. Nutrients. 2019 Sep 24;11(10):2285. doi: 10.3390/nu11102285.
• Landis BN, Welge-Luessen A, Bramerson A, Bende M, Mueller CA, Nordin S, Hummel T. "Taste Strips" - a rapid, lateralized, gustatory bedside identification test based on impregnated filter papers. J Neurol. 2009 Feb;256(2):242-8. doi: 10.1007/s00415-009-0088-y. Epub 2009 Feb 7.
• Mueller CA, Pintscher K, Renner B. Clinical test of gustatory function including umami taste. Ann Otol Rhinol Laryngol. 2011 Jun;120(6):358-62. doi: 10.1177/000348941112000602.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Breast cancer; Nutritional status; Taste disorders; Dysgeusia; Taste perception; Chemotherapy effects; Sensory testing
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Breast Neoplasms; Dysgeusia; Taste Disorders; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: GustiAmo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No