Self-Assessment and Management for Chemotherapy-Induced Taste Changes

(TAS Trial)

Overseen By Mary L Hook, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Head/neck cancer, Dysgeusia, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of different methods for detecting and managing taste changes in individuals starting chemotherapy. It aims to determine whether a self-assessment tool (Taste Alteration Self-Assessment) identifies taste changes more effectively than standard care and whether it leads to better management, maintaining stable food intake. Participants will be divided into two groups: one will receive standard care, while the other will use the tool to track and manage taste changes. Individuals beginning chemotherapy for common cancer types who can communicate in English may be suitable for this study. As an unphased trial, this study provides a unique opportunity to enhance care for future patients experiencing taste changes during chemotherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this self-assessment and management protocol is safe for managing chemotherapy-induced taste changes?

Research shows that changes in taste commonly affect cancer patients undergoing chemotherapy. These changes can alter food perception, leading to reduced appetite and food dislikes. Studies have found that the Chemotherapy-induced Taste Alteration Scale (CiTAS) effectively identifies and manages these taste changes.

In previous studies with cancer patients, the CiTAS tool checked for taste changes without causing significant harm or discomfort. This tool helps patients notice and track taste changes and provides guidance on managing them. The process has been well-received, with no reports of serious side effects from this self-assessment and management method.

In summary, past research indicates that the taste alteration self-assessment and management approach is safe. It helps patients manage taste changes without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Taste Alteration Self-Assessment because it empowers patients to actively manage their chemotherapy-induced taste changes. Unlike the standard care that offers general advice, this new approach uses a specific assessment tool called the Chemotherapy-induced Taste Alterations Scale (CiTAS). This tool helps patients identify the severity of their taste changes and select tailored interventions based on evidence. The hands-on involvement and personalized strategies could lead to more effective management of taste alterations, enhancing patients' quality of life during chemotherapy.

What evidence suggests that this trial's treatments could be effective for managing chemotherapy-induced taste changes?

Research has shown that changes in taste are common after chemotherapy and can significantly affect patients' eating habits. One study found that 38% to 77% of cancer patients experienced noticeable taste changes following chemotherapy, which can lead to poor nutrition and other health issues. In this trial, participants in the "Treatment - TA Self-monitoring and Self-management" arm will use the Chemotherapy-induced Taste Alterations Scale (CiTAS) to identify taste changes and apply self-care strategies, such as eating milder foods or improving oral care, to manage these symptoms more effectively. By using these assessments and strategies, patients may reduce the impact of taste changes and maintain better eating habits. Meanwhile, participants in the "Control/Usual Care" arm will receive standard care with additional evaluation of taste alteration severity. ^{1 5 6 7 8}

Who Is on the Research Team?

Mary L Hook, PhD, RN

Principal Investigator

Aurora Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals experiencing taste changes due to chemotherapy. Participants must be starting their initial chemotherapy and willing to complete assessments, engage in self-management, and work with nurse coaches. Specific details on inclusion or exclusion criteria are not provided.

Inclusion Criteria

Initiating chemotherapy (first day/first cycle) at participating clinics

My cancer is one of the most common types.

English speaking/reading (without an interpreter)

Exclusion Criteria

Known eating disorder

I have a genetic condition that affects my sense of taste.

I have someone legally designated to make decisions for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment and Education

Participants complete baseline assessment and receive patient education based on assigned intervention (usual care vs. treatment) before starting chemotherapy

1 week

1 visit (in-person)

Chemotherapy and Intervention

Participants engage in TA management between chemotherapy infusion clinic visits, complete TA assessments, and work with nurse coaches

4 chemotherapy cycles

Visits as per chemotherapy schedule

Data Collection and Continued Intervention

Complete study data collection on the 4th chemotherapy cycle and continue intervention

4 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, with final data collection at 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Taste Alteration Self-Assessment
• Taste Alteration Self-Management

Trial Overview

The study tests if a standard assessment can better detect taste alterations (TA) from chemotherapy than usual care. It also examines the effectiveness of patient education and interventions in managing TA symptoms and maintaining food intake over six months.

How Is the Trial Designed?

Group I: Treatment - TA Self-monitoring and Self-management Experimental Treatment 2 Interventions

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.

Group II: Control/Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Taste changes are a common side effect for patients undergoing chemotherapy with drugs like cisplatin, carboplatin, or cyclophosphamide, and these changes can significantly impact their ability to eat.

A self-care suggestion sheet was effective in helping patients manage taste changes, with strategies such as avoiding strong flavors, maintaining good oral hygiene, and eating smaller meals being particularly beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care strategies to cope with taste changes after chemotherapy. Rehwaldt, M., Wickham, R., Purl, S., et al.[2021]

In a study of 243 adult patients undergoing chemotherapy, a majority reported experiencing taste alterations (TAs), with the most common being difficulty in tasting saltiness, followed by umami and sweetness.

The severity and characteristics of TAs varied across different chemotherapy regimens and were linked to a decrease in quality of life, highlighting the need for healthcare professionals to assess and manage these side effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence, Severity, and Self-Reported Characteristics of Taste Alterations in Patients Receiving Chemotherapy. Campagna, S., Gonella, S., Sperlinga, R., et al.[2019]

Chemotherapy often leads to taste alterations in patients, significantly affecting their quality of life.

There is a need for consistent evaluation of taste changes in clinical practice to better support patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy-Induced Taste Alteration. Penna, S.[2023]

The Chinese version of the chemotherapy-induced taste alteration scale (C-CiTAS) was found to be a reliable and valid tool for assessing taste changes in 227 cancer patients undergoing chemotherapy, demonstrating strong psychometric properties.

The C-CiTAS showed good construct, convergent, and discriminant validity, with high reliability scores, including a Cronbach's alpha of 0.900 for the overall scale, indicating it is effective for evaluating taste alterations in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Chinese version of the chemotherapy-induced taste alteration scale. Pang, D., Qian, L., Chen, ZJ., et al.[2020]

Taste changes are a common and often severe side effect for patients undergoing chemotherapy, significantly impacting their quality of life, especially with drugs like cisplatin and doxorubicin.

Despite the frequency and distress caused by taste changes, healthcare providers rarely discuss this issue with patients or offer self-management strategies, highlighting a gap in patient care and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taste changes experienced by patients receiving chemotherapy. Wickham, RS., Rehwaldt, M., Kefer, C., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6776177/

The CiTAS scale for evaluating taste alteration induced by ...

All patients enrolled had taste alteration: 10% of the severe sample, and 50% of the entire moderate sample. Such taste alterations showed a negative ...

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onf.ons.org

onf.ons.org/publications-research/onf/40/2/development-and-validation-chemotherapy-induced-taste-alteration

Development and Validation of a Chemotherapy-Induced ...

Purpose/Objectives: To develop an instrument to assess the specific symptoms of chemotherapy-induced taste alterations. Design: Cross-sectional study.

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trialx.com

trialx.com/clinical-trials/listings/295740/taste-alterations-study/

Taste Alterations Study | Clinical Research Trial Listing ...

The intervention involves using a more extensive valid/reliable assessment tool (Chemotherapy-induced Taste Alterations Scale (CiTAS) teaching ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1462388924002333

Prevalence and risk factors of chemotherapy-induced taste ...

Chemotherapy-induced taste alterations (CiTA) are significant predictors of gastrointestinal symptoms, malnutrition, and poor prognosis.

5.

researchgate.net

researchgate.net/publication/335570628_The_CiTAS_scale_for_evaluating_taste_alteration_induced_by_chemotherapy_state_of_the_art_on_its_clinical_use

(PDF) The CiTAS scale for evaluating taste alteration ...

It can be said that until now CiTAS has not been used to a large extent for evaluating taste, even at a late stage in patients undergoing chemotherapy.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3228016/

Taste Alterations in Cancer Patients Receiving ...

Taste alterations (TAs) are a frequent but under-recognized treatment side effect in cancer patients undergoing chemotherapy (CT).

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1462388925002510

Stratified Linear Regression Analysis of Factors Associated ...

The total mean score for the Chemotherapy-induced Taste Alteration Scale (CiTAS) was 25.51 (SD=9.51), with feeding disturbance showing the ...

8.

link.springer.com

link.springer.com/article/10.1007/s00520-021-06066-3

Characteristics of taste alterations in people receiving ...

This study aimed to evaluate taste alteration characteristics in patients receiving taxane-based chemotherapy and investigate the association of taste ...