Taste Alterations Study

NCT06669416 | Recruiting

• 1 other identifier: IRB00120499
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The main questions it aims to answer are:

1. 1.Does completing a standard assessment increase the detection of chemotherapy induced taste changes compared with usual care (no assessment)? What TA are experienced? Are there any patterns in TA symptom occurrence based on age, sex, race/ethnicity, cancer type, chemotherapy agent, etc.
2. 2.Do patients take action to deal with the TA? What strategies are used? Do patients in the intervention group use the assessments to select interventions?
3. 3.Do the interventions lessen TA symptoms and maintain food intake? Is the treatment (in-depth assessment and education) more effective in lessening the intensity of TA than usual care? Which level of assessment is needed to support symptom management to reduce symptom severity?

Conditions

Chemotherapy Side Effects; Taste, Altered

Keywords

self-management; cluster randomized control trial

Outcome Measures

Primary Outcomes (3)

• Taste Alteration Severity

  A single item question with ordinal rating will be used to confirm taste alterations and evaluate severity of TA (control) The CiTAS tool (18 item ordinal rating tool) will be used to confirm taste alterations and evaluate severity of TA (treatment)

  Through study completion, an average of 6 months.

• Body mass index (BMI)

  BMI is measured to monitor for changes in weight relative to height; It is used to monitor for changes in weight that may indicate that patient is experiencing weight loss during chemotherapy treatment.

  Through study completion, an average of 6 months.

• Dietary intake

  All patients will be asked to report number of meals/day, number of snacks/day, and number of supplements per day as an estimate of food intake during chemotherapy.

  Through study completion, an average of 6 months.

Study Arms (2)

Control/Usual Care

NO INTERVENTION

Chemotherapy infusion clinics deliver infusion services based on the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) Chemotherapy Administration Safety Standards (2020) including standard toxicity screening and providing standard chemotherapy patient education with general information for managing nausea and other gastrointestinal side effects and nutrition tips. Usual care patients will be supplemented with a single-item question to evaluate taste alteration severity and to gather information about what they are doing and their diet intake.

Treatment - TA Self-monitoring and Self-management

EXPERIMENTAL

The nurse-led intervention involves using a valid/reliable TA assessment tool (Chemotherapy-induced Taste Alterations Scale (CiTAS) and teaching the patient to use the assessments and the evidence-based Patient Education Sheet to select assessment-driven interventions to manage TA symptoms. Data is collected about the specific actions prescribed in the teaching tool to identify which interventions were used and their overall impact.

Behavioral: Taste Alteration Self-Assessment; Behavioral: Taste Alternation Self-Management

Interventions

Taste Alteration Self-Assessment BEHAVIORAL

The nurse-led intervention involves using a valid/reliable TA assessment tool (Chemotherapy-induced Taste Alterations Scale (CiTAS) and teaching the patient to select assessment-driven interventions to manage TA symptoms.

Treatment - TA Self-monitoring and Self-management

Taste Alternation Self-Management BEHAVIORAL

The nurse-led intervention involves teaching the patient to use the assessments and the evidence-based Patient Education Sheet to select assessment-driven interventions to manage their symptoms. Data will be collected about the specific actions prescribed in the teaching tool and to identify which interventions were used and their overall impact.

Treatment - TA Self-monitoring and Self-management

Eligibility Criteria

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

You may qualify if:

• Medical diagnosis of cancer with types limited to the top cancer types \[Note: Cancer types that are rare will be excluded\]
• Initiating chemotherapy (first day/first cycle) at participating clinics
• English speaking/reading (without an interpreter)

You may not qualify if:

• Substitute decision-maker (activated)
• History of head/neck cancer or irradiation
• Known genetic/metabolic disorder impacting taste (preexisting dysgeusia)
• Known eating disorder
• Receiving enteral or parenteral nutrition (special nutritional needs)
• Pregnant women (unique needs)
• Patients with medical orders for end of life/hospice care

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

RECRUITING

Related Publications (9)

• Kano T, Kanda K. Development and validation of a chemotherapy-induced taste alteration scale. Oncol Nurs Forum. 2013 Mar;40(2):E79-85. doi: 10.1188/13.ONF.E79-E85.

  PMID: 23448748 BACKGROUND

• Kinjo T, Kanda K, Fujimoto K. Effects of a self-monitoring intervention in breast cancer patients suffering from taste alterations induced by chemotherapy: A randomized, parallel-group controlled trial. Eur J Oncol Nurs. 2021 Jun;52:101956. doi: 10.1016/j.ejon.2021.101956. Epub 2021 Apr 14.

  PMID: 33940487 BACKGROUND

• Asano S, Sawatari H, Mentani H, Shimada Y, Takahashi M, Fudano K, Sasaki K, Niitani M, Tanabe K, Kataoka T. Taste Disorders: Effect of Education in Patients With Breast Cancer Receiving Chemotherapy. Clin J Oncol Nurs. 2020 Jun 1;24(3):265-271. doi: 10.1188/20.CJON.265-271.

  PMID: 32441675 BACKGROUND

• Barlow LA. The sense of taste: Development, regeneration, and dysfunction. WIREs Mech Dis. 2022 May;14(3):e1547. doi: 10.1002/wsbm.1547. Epub 2021 Nov 30.

  PMID: 34850604 BACKGROUND

• Braud A, Boucher Y. Taste disorder's management: a systematic review. Clin Oral Investig. 2020 Jun;24(6):1889-1908. doi: 10.1007/s00784-020-03299-0. Epub 2020 May 8.

  PMID: 32385655 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

• Joseph PV, Nolden A, Kober KM, Paul SM, Cooper BA, Conley YP, Hammer MJ, Wright F, Levine JD, Miaskowski C. Fatigue, Stress, and Functional Status are Associated With Taste Changes in Oncology Patients Receiving Chemotherapy. J Pain Symptom Manage. 2021 Aug;62(2):373-382.e2. doi: 10.1016/j.jpainsymman.2020.11.029. Epub 2020 Nov 28.

  PMID: 33259906 BACKGROUND

• von Grundherr J, Koch B, Grimm D, Salchow J, Valentini L, Hummel T, Bokemeyer C, Stein A, Mann J. Impact of taste and smell training on taste disorders during chemotherapy - TASTE trial. Cancer Manag Res. 2019 May 16;11:4493-4504. doi: 10.2147/CMAR.S188903. eCollection 2019.

  PMID: 31191011 BACKGROUND

• Kumbargere Nagraj S, George RP, Shetty N, Levenson D, Ferraiolo DM, Shrestha A. Interventions for managing taste disturbances. Cochrane Database Syst Rev. 2017 Dec 20;12(12):CD010470. doi: 10.1002/14651858.CD010470.pub3.

  PMID: 29260510 BACKGROUND

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary L Hook, PhD, RN

  Aurora Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary L Hook, PhD, RN

CONTACT

414-218-0990; mary.hook@aah.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment/Control (usual care)

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 1, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)