Taste DisordersGustiAmoNCT07317752
Incidence of Dysgeusia in Breast Cancer Patients Undergoing Chemotherapy
An observational study of Taste Disorders and Breast Cancer, run by Azienda Sanitaria Locale CN2 Alba-Bra.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Taste Disorders, Breast Cancer, Quality of Life
- What is being tested?
- Taste Assessment / Nutritional Assessment / Quality of Life Assessment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Taste Disorders, Breast Cancer, Quality of Life, Taste Perception, Dysgeusia, Chemotherapy Effects
- Being tested
- Taste Assessment / Nutritional Assessment / Quality of Life Assessment
- Keywords
- Dysgeusia, Taste disorders, Breast cancer, Quality of life, Taste perception, Chemotherapy effects, Nutritional status, Sensory testing
- Medical subject headings
- Taste Disorders, Breast Neoplasms, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taste Assessment / Nutritional Assessment / Quality of Life AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Taste Assessment / Nutritional Assessment / Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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 (7)
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.
Measured: - 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.
Measured: - 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.
Measured: - 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.
Measured: - 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).
Measured: - 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.
Measured: - 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").
Measured: - 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Taste DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-Bra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317752
- Sponsor's protocol ID
- GustiAmo
- Acronym
- GustiAmo
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36368973Turcott 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.
PubMed 26943275Epstein 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.
PubMed 30927113Nolden 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.
PubMed 31554217Landis 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.
PubMed 19221845Mueller 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.
PubMed 21774441Mueller 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.
PubMed 12677732Buttiron 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.
PubMed 36768861