Incidence of Dysgeusia in Breast Cancer Patients Undergoing Chemotherapy

NCT07317752 | Not Yet Recruiting

• 1 other identifier: GustiAmo
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Breast Cancer; Quality of Life; Taste Perception; Dysgeusia; Chemotherapy Effects; Nutritional Status; Sensory Testing; Taste Disorders

Keywords

Dysgeusia; Taste disorders; Breast cancer; Quality of life; Taste perception; Chemotherapy effects; Nutritional status; Sensory testing

Outcome Measures

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.

  - 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

  - 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

  - 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

  - 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

  - 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

  - 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

Study Arms (1)

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

Interventions

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.

Non-Metastatic Breast Cancer Patients Receiving Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale CN2 Alba-Bra: lead

Related Publications (8)

• 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.

  PMID: 36368973 BACKGROUND

• 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.

  PMID: 26943275 BACKGROUND

• 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.

  PMID: 30927113 BACKGROUND

• 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.

  PMID: 31554217 BACKGROUND

• 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.

  PMID: 19221845 BACKGROUND

• 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.

  PMID: 21774441 BACKGROUND

• 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.

  PMID: 12677732 BACKGROUND

• 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.

  PMID: 36768861 BACKGROUND

MeSH Terms

Conditions

Taste Disorders; Breast Neoplasms; Dysgeusia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Cloè Dalla Costa, MD

CONTACT

+39.0172.1408493; cdallacosta@aslcn2.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12