Clinical trial · Observational

Incidence of Dysgeusia in Breast Cancer Patients Undergoing Chemotherapy

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

NCT07317752CI-TRIAL-00100116GustiAmonot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (8)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Chemotherapy Effects	—	UNRESOLVED	—
Dysgeusia	—	UNRESOLVED	—
Nutritional Status	—	UNRESOLVED	—
Quality of Life	—	UNRESOLVED	—
Sensory Testing	—	UNRESOLVED	—
Taste Disorders	—	UNRESOLVED	—
Taste Perception	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Taste Assessment / Nutritional Assessment / Quality of Life Assessment	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Non-Metastatic Breast Cancer Patients Receiving Chemotherapy
description
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.
interventionNames
1. Other: Taste Assessment / Nutritional Assessment / Quality of Life Assessment

Primary outcomes (1)

measure
Incidence of dysgeusia during chemotherapy
timeFrame
- 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
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (8)

BACKGROUNDSawicki 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. PMID 36368973
BACKGROUNDTurcott 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. PMID 26943275
BACKGROUNDEpstein 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. PMID 30927113
BACKGROUNDNolden 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. PMID 31554217
BACKGROUNDLandis 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. PMID 19221845
BACKGROUNDMueller 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. PMID 21774441
BACKGROUNDMueller 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.