Chemotherapy-Related Taste AlterationNCT07670221
Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer
A study testing Nurse-led Self-Management Program in people with Chemotherapy-Related Taste Alteration, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Taste alteration is a common and distressing symptom experienced by women with breast cancer receiving taxane-based chemotherapy. This symptom may negatively affect food intake, nutritional status, psychological well-being, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-Related Taste Alteration
- What is being tested?
- Nurse-led Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to 24 Aug 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Literate
- Diagnosed with breast cancer
- Receiving taxane-based chemotherapy
- Having a score of 1 or 2 for taste alteration according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) after the first cycle of chemotherapy
- Willing to participate in the study and providing written informed consent
Who cannot join
- Having any communication barrier that prevents participation in the study
- Having a diagnosed psychiatric disorder
- Receiving radiotherapy
- Having metastasis
- Having a diagnosed physical disease that may affect food intake, such as ulcerative colitis or Crohn's disease
- Receiving enteral or parenteral nutrition support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Provincal Health Directorate Izmir City Hospital
Izmir
Pinar Zorba Bahceli, PhD, +90 553 487 25 50, pinarzorba85@gmail.com
About this study
Official title: The Effect of a Nurse-Led Self-Management Program on Taste Alteration, Nutritional Status, and Quality of Life in Women With Breast Cancer Receiving Taxane-Based Chemotherapy: A Randomized Controlled Trial
Taste alteration is a common and distressing symptom experienced by women with breast cancer receiving taxane-based chemotherapy. This symptom may negatively affect food intake, nutritional status, psychological well-being, and quality of life. Although several approaches have been suggested for the management of chemotherapy-related taste alteration, evidence regarding structured nurse-led self-management interventions in this patient group remains limited.
Read the detailed description
This parallel group randomized controlled trial aims to evaluate the effect of a nurse-led self-management program on taste alteration, nutritional status, and quality of life in women with breast cancer receiving taxane-based chemotherapy. Eligible participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a nurse-led self-management program in addition to routine care, while participants in the control group will receive routine care alone. The program is designed to support participants in recognizing, monitoring, and managing taste alteration and related nutritional problems during chemotherapy.
- Conditions
- Chemotherapy-Related Taste Alteration
- Being tested
- Nurse-led Self-Management Program
- Keywords
- Breast cancer, Taste alteration, Self-management, Nurse-led intervention, Nutritional status, Quality of life
- Medical subject headings
- Breast Neoplasms, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Self-Management ProgramBehavioural
This 8-week nurse-led self-management program is a behavioral supportive care intervention designed specifically for women with breast cancer receiving taxane-based chemotherapy. The program focuses on the self-management of taxane-related taste alteration and associated nutritional problems. It includes structured nurse-led education, regular assessment of taste-related symptoms, self-monitoring of taste changes and food-related difficulties, individualized counseling, goal setting, problem-solving support, and practical strategies to maintain food intake and quality of life during chemotherapy. The intervention is delivered in addition to routine care and differs from general chemotherapy education by specifically integrating taste alteration management, nutritional self-management, and nurse-led follow-up within a structured 8-week program.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led Self-Management Group | Experimental | Participants in this group will receive a nurse-led self-management program in addition to usual care. The program is designed to support women with breast cancer receiving taxane-based chemotherapy in recognizing, monitoring, and managing taste alteration and related nutritional problems. The intervention will include education, symptom monitoring, self-management strategies, and nurse-led supportive guidance to improve taste alteration, nutritional status, and quality of life during chemotherapy. Receives: Behavioral: Nurse-led Self-Management Program |
| Control Group | No intervention | Participants in this group will receive routine care provided during taxane-based chemotherapy. They will not receive the nurse-led self-management program during the study period. Outcome assessments will be performed according to the same schedule as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Chemotherapy-Induced Taste Alteration Scale Score
Taste alteration will be assessed using the Chemotherapy-Induced Taste Alteration Scale (CiTAS). The scale includes 18 items and four subdomains: decline in basic taste, discomfort, phantogeusia and parageusia, and general taste alterations. Scores range from 1 to 5 for each item or subdomain, with higher scores indicating greater taste alteration and taste-related discomfort. Change in CiTAS scores across baseline, Week 5, and Week 9 will be evaluated.
Measured: Baseline, Week 5, and Week 9
Change in Nutritional Risk Score
Nutritional risk will be assessed using the Nutritional Risk Screening 2002 (NRS-2002) form. The NRS-2002 evaluates nutritional status and disease severity, with an additional age-related score for participants aged 70 years or older. A total score of 3 or higher indicates nutritional risk or malnutrition risk. Change in NRS-2002 scores across baseline, Week 5, and Week 9 will be evaluated.
Measured: Baseline, Week 5, and Week 9
Change in Quality of Life Score
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, version 3.0 (EORTC QLQ-C30 v3.0). The questionnaire includes global health status, functional status, and symptom status domains. Scores are transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores for global health status and functional status indicate better quality of life, whereas higher symptom scores indicate greater symptom burden. Change in EORTC QLQ-C30 scores across baseline, Week 5, and Week 9 will be evaluated.
Measured: Baseline, Week 5, and Week 9
Secondary outcomes (8)
Change in Red Blood Cell Count
Red blood cell count will be assessed using routine hematological laboratory test results. The outcome will be reported as 10⁶ cells/µL.
Measured: Baseline, Week 5, and Week 9
Change in Hemoglobin Level
Hemoglobin level will be assessed using routine hematological laboratory test results. The outcome will be reported as g/dL.
Measured: Baseline, Week 5, and Week 9
Change in Hematocrit Level
Hematocrit level will be assessed using routine hematological laboratory test results. The outcome will be reported as a percentage.
Measured: Baseline, Week 5, and Week 9
Change in Serum Albumin Level
Serum albumin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as g/dL.
Measured: Baseline, Week 5, and Week 9
Change in Serum Prealbumin Level
Serum prealbumin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as mg/dL.
Measured: Baseline, Week 5, and Week 9
Change in Serum Transferrin Level
Serum transferrin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as mg/dL.
Measured: Baseline, Week 5, and Week 9
Change in Total Cholesterol Level
Total cholesterol level will be assessed using routine biochemical laboratory test results. The outcome will be reported as mg/dL.
Measured: Baseline, Week 5, and Week 9
Change in Body Mass Index
Body mass index will be calculated as body weight in kilograms divided by height in meters squared. The outcome will be reported as kg/m².
Measured: Baseline, Week 5, and Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start16 Feb 2026
- Primary completion19 Jul 2026 (estimated)
- Study completion24 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Related Taste AlterationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Zorba Bahceli, PhD RN, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670221
- Sponsor's protocol ID
- 2025/3
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse-Led Self-Management Program on Taste Alteration, Nutritional Status, and Quality of Life in Women With Breast Cancer Receiving Taxane-Based Chemotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07670221
- Acronym / sponsor ID
- 2025/3
- Conditions
- Chemotherapy-Related Taste Alteration
- Keywords
- Breast cancer, Taste alteration, Self-management, Nurse-led intervention, Nutritional status, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 19 Jul 2026 (estimated)
- Study completion
- 24 Aug 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Taste alteration is a common and distressing symptom experienced by women with breast cancer receiving taxane-based chemotherapy. This symptom may negatively affect food intake, nutritional status, psychological well-being, and quality of life. Although several approaches have been suggested for the management of chemotherapy-related taste alteration, evidence regarding structured nurse-led self-management interventions in this patient group remains limited.
Detailed description
This parallel group randomized controlled trial aims to evaluate the effect of a nurse-led self-management program on taste alteration, nutritional status, and quality of life in women with breast cancer receiving taxane-based chemotherapy. Eligible participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a nurse-led self-management program in addition to routine care, while participants in the control group will receive routine care alone. The program is designed to support participants in recognizing, monitoring, and managing taste alteration and related nutritional problems during chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led Self-Management Group | Experimental | Behavioral: Nurse-led Self-Management ProgramParticipants in this group will receive a nurse-led self-management program in addition to usual care. The program is designed to support women with breast cancer receiving taxane-based chemotherapy in recognizing, monitoring, and managing taste alteration and related nutritional problems. The intervention will include education, symptom monitoring, self-management strategies, and nurse-led supportive guidance to improve taste alteration, nutritional status, and quality of life during chemotherapy. |
| Control Group | No intervention | –Participants in this group will receive routine care provided during taxane-based chemotherapy. They will not receive the nurse-led self-management program during the study period. Outcome assessments will be performed according to the same schedule as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Literate
- Diagnosed with breast cancer
- Receiving taxane-based chemotherapy
- Having a score of 1 or 2 for taste alteration according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) after the first cycle of chemotherapy
Key exclusion criteria (6 listed)
- Having any communication barrier that prevents participation in the study
- Having a diagnosed psychiatric disorder
- Receiving radiotherapy
- Having metastasis
- Having a diagnosed physical disease that may affect food intake, such as ulcerative colitis or Crohn's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led Self-Management ProgramThis 8-week nurse-led self-management program is a behavioral supportive care intervention designed specifically for women with breast cancer receiving taxane-based chemotherapy. The program focuses on the self-management of taxane-related taste alteration and associated nutritional problems. It includes structured nurse-led education, regular assessment of taste-related symptoms, self-monitoring of taste changes and food-related difficulties, individualized counseling, goal setting, problem-solving support, and practical strategies to maintain food intake and quality of life during chemotherapy. The intervention is delivered in addition to routine care and differs from general chemotherapy education by specifically integrating taste alteration management, nutritional self-management, and nurse-led follow-up within a structured 8-week program. | Behavioural | Nurse-led Self-Management Group |
Primary outcome
Change in Chemotherapy-Induced Taste Alteration Scale Score
Time frame: Baseline, Week 5, and Week 9
Taste alteration will be assessed using the Chemotherapy-Induced Taste Alteration Scale (CiTAS). The scale includes 18 items and four subdomains: decline in basic taste, discomfort, phantogeusia and parageusia, and general taste alterations. Scores range from 1 to 5 for each item or subdomain, with higher scores indicating greater taste alteration and taste-related discomfort. Change in CiTAS scores across baseline, Week 5, and Week 9 will be evaluated.
Change in Nutritional Risk Score
Time frame: Baseline, Week 5, and Week 9
Nutritional risk will be assessed using the Nutritional Risk Screening 2002 (NRS-2002) form. The NRS-2002 evaluates nutritional status and disease severity, with an additional age-related score for participants aged 70 years or older. A total score of 3 or higher indicates nutritional risk or malnutrition risk. Change in NRS-2002 scores across baseline, Week 5, and Week 9 will be evaluated.
Change in Quality of Life Score
Time frame: Baseline, Week 5, and Week 9
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, version 3.0 (EORTC QLQ-C30 v3.0). The questionnaire includes global health status, functional status, and symptom status domains. Scores are transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores for global health status and functional status indicate better quality of life, whereas higher symptom scores indicate greater symptom burden. Change in EORTC QLQ-C30 scores across baseline, Week 5, and Week 9 will be evaluated.
8 secondary outcomes
Change in Red Blood Cell Count
Time frame: Baseline, Week 5, and Week 9
Change in Hemoglobin Level
Time frame: Baseline, Week 5, and Week 9
Change in Hematocrit Level
Time frame: Baseline, Week 5, and Week 9
Change in Serum Albumin Level
Time frame: Baseline, Week 5, and Week 9
Change in Serum Prealbumin Level
Time frame: Baseline, Week 5, and Week 9
Change in Serum Transferrin Level
Time frame: Baseline, Week 5, and Week 9
Change in Total Cholesterol Level
Time frame: Baseline, Week 5, and Week 9
Change in Body Mass Index
Time frame: Baseline, Week 5, and Week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Self-Management Program in people with Chemotherapy-Related Taste Alteration, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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 26 Jun 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 Turkey (Türkiye). 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 Pinar Zorba Bahceli, PhD (+90 553 487 25 50, pinarzorba85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Chemotherapy-Induced Taste Alteration Scale Score (time frame: Baseline, Week 5, and Week 9). 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?
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 26 Jun 2026.