AzTrials
AzTrials

Chemotherapy Side EffectsTASNCT06669416

Taste Alterations Study

A study testing Taste Alteration Self-Assessment and Taste Alternation Self-Management in people with Chemotherapy Side Effects and Taste, Altered, run by Wake Forest University Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The main questions it aims to answer are: 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy Side Effects, Taste, Altered
What is being tested?
Taste Alteration Self-Assessment and Taste Alternation Self-Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
1 Dec 2024to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mary L Hook, PhD, RN contact

414-218-0990

mary.hook@aah.org

United States1 site, 1 recruiting
  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Recruiting

Other trials in United States

About this study

Official title: Effects of Patient Education and Self-Management in Cancer Patients Who Experience Chemotherapy-Induced Taste Alterations

The main questions it aims to answer are:

  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. 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. 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?
Read more

Participants will:

Complete baseline assessment before starting their initial chemotherapy infusion (all patients) Participate in baseline patient education based on assigned intervention (usual care vs. treatment) Engage in TA management between chemotherapy infusion clinic visits based on education Visit the clinic for chemotherapy infusions as scheduled; Complete TA assessments and reporting based on intervention; Work with nurse coaches to answer questions and help with the intervention.

Complete study data collection on the 4th chemotherapy cycle (but continue intervention) Complete final data collection at 6 months

Read the detailed description

BACKGROUND/RATIONALE: Chemotherapy-induced taste alteration (TA) is a common problem for cancer patients with reported prevalence ranging from 35% to 69%. TA systems are associated with decreased dietary intake, malnutrition, and decreased quality of life with no known treatment. Researchers have demonstrated that breast cancer patients were able to control TA with the use of patient self-monitoring and self-management strategies, but these strategies are relatively untested. Research is needed to confirm the effectiveness of this nurse-led intervention when delivered by clinicians with a heterogeneous patient population.

PURPOSE To increase our understanding of the patient experience with TA during chemotherapy and test if adding steps to assess and lessen taste alterations works better than usual care. The infusion clinics will be randomly assigned and trained to provide usual care or usual care with added strategies. Patients receive care method based on clinic assignment (control/treatment). The study does not involve the use of experimental drugs, devices, or procedure.

METHOD: This prospective cluster randomized controlled trial (RCT) is designed to enroll consenting adult cancer patients (n=50/clinic x 8 clinics; N=400) who initiate chemotherapy to evaluate the effect of a nurse-led intervention to engage patients in assessing and self-managing taste alterations (TA) during the first (4) chemotherapy cycles with six months.

INTERVENTION: The nurse-led intervention involves using a single item TA assessment question and an intervention tracking process to evaluate change in outcomes for both groups. The intervention involves using a more extensive valid/reliable assessment tool (Chemotherapy-induced Taste Alterations Scale (CiTAS) teaching the patient to use the findings and the evidence-based Patient Education sheet to select assessment-driven interventions to manage TA symptoms.

OUTCOMES: TA severity (single item and scale); Interventions Used; Patient-reported Effect; Dietary Intake, and BMI.

This study will advance the science by designing and testing the effectiveness of a nurse-led intervention to support infusion clinic patients in TA self-monitoring and management for a heterogenous patient populations beyond breast cancer.

Being tested
Taste Alteration Self-Assessment, Taste Alternation Self-Management
Keywords
self-management, cluster randomized control trial
Medical subject headings
Dysgeusia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Taste Alteration Self-AssessmentBehavioural

    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.

  • Taste Alternation Self-ManagementBehavioural

    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.

Study groups in NCT06669416
Study groupRoleWhat they receive
Control/Usual CareNo interventionChemotherapy 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-managementExperimentalThe 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.
Receives: Behavioral: Taste Alteration Self-Assessment; Behavioral: Taste Alternation Self-Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Through study completion, an average of 6 months.

  2. 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.

    Measured: Through study completion, an average of 6 months.

  3. 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.

    Measured: Through study completion, an average of 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2024
  2. Study start1 Dec 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Treatment/Control (usual care)
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06669416
Sponsor's protocol ID
IRB00120499
Acronym
TAS
Status last verified
Sep 2026
First submitted
25 Oct 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23448748
  • 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.

    PubMed 33940487
  • 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.

    PubMed 32441675
  • 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.

    PubMed 34850604
  • 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.

    PubMed 32385655
  • 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.

    PubMed 36768861
  • 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.

    PubMed 33259906
  • 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.

    PubMed 31191011
  • 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.

    PubMed 29260510

Questions about this trial

What is this clinical trial studying?

A study testing Taste Alteration Self-Assessment and Taste Alternation Self-Management in people with Chemotherapy Side Effects and Taste, Altered, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mary L Hook, PhD, RN (414-218-0990, mary.hook@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Taste Alteration Severity (time frame: Through study completion, an average of 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06669416, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in