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NCT Number: NCT07670221

Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer

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.

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Key information

Conditions

Chemotherapy-Related Taste Alteration Breast Diseases Breast Neoplasms Dysgeusia Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Taste Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Provincal Health Directorate Izmir City Hospital

Izmir, Turkey (Türkiye)

Location status: Recruiting

Location contact

Pinar Zorba Bahceli, PhD

CONTACT

[email protected]

+90 553 487 25 50

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nurse-led self-management Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Red Blood Cell Count

    Time frame: Baseline, Week 5, and Week 9

    Red blood cell count will be assessed using routine hematological laboratory test results. The outcome will be reported as 10⁶ cells/µL.

  2. Change in Hemoglobin Level

    Time frame: Baseline, Week 5, and Week 9

    Hemoglobin level will be assessed using routine hematological laboratory test results. The outcome will be reported as g/dL.

  3. Change in Hematocrit Level

    Time frame: Baseline, Week 5, and Week 9

    Hematocrit level will be assessed using routine hematological laboratory test results. The outcome will be reported as a percentage.

  4. Change in Serum Albumin Level

    Time frame: Baseline, Week 5, and Week 9

    Serum albumin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as g/dL.

  5. Change in Serum Prealbumin Level

    Time frame: Baseline, Week 5, and Week 9

    Serum prealbumin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as mg/dL.

  6. Change in Serum Transferrin Level

    Time frame: Baseline, Week 5, and Week 9

    Serum transferrin level will be assessed using routine biochemical laboratory test results. The outcome will be reported as mg/dL.

  7. Change in Total Cholesterol Level

    Time frame: Baseline, Week 5, and Week 9

    Total cholesterol level will be assessed using routine biochemical laboratory test results. The outcome will be reported as mg/dL.

  8. Change in Body Mass Index

    Time frame: Baseline, Week 5, and Week 9

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Ozel, RN

CONTACT

[email protected]

+90 543 227 98 13

Pinar Zorba Bahceli, PhD

CONTACT

[email protected]

+90 553 487 25 50

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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