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NCT Number: NCT07154966

Taste Alteration, Sarcopenia, and Malnutrition in Gynecologic Cancer Patients Receiving Carboplatin-Paclitaxel Chemotherapy

This observational study aims to evaluate chemotherapy-induced taste alterations, sarcopenia, and malnutrition in patients with gynecologic malignancies (ovarian, fallopian tube, and endometrial cancer) treated with standard carboplatin and paclitaxel. Eligible patients will receive six cycles of chemotherapy (carboplatin area under the curve [AUC] 5 + paclitaxel 175-200 mg/m², every 21 days), and assessments will be performed at baseline (before chemotherapy), after the 3rd cycle (~9 weeks), and after the 6th cycle (~18 weeks). Validated tools will be used, including the Chemotherapy-Induced Taste Alteration Scale (CITAS, Turkish validated, range 18-90; higher scores indicate greater severity of dysgeusia), the Patient-Generated Subjective Global Assessment (PG-SGA, Turkish validated, range 0-35; higher scores indicate worse nutritional status), and Computed Tomography (CT)-based Skeletal Muscle Index (SMI) at the L3 vertebra level.

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Key information

Conditions

Ovarian Cancer (OvCa) Adnexal Diseases Atrophy Cancer-Associated Malnutrition Cancer-Associated Sarcopeni Chemotherapy-Induced Taste Alteration Dysgeusia Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Fallopian Tube Cancers Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Malnutrition Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Diseases Ovarian Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Sensation Disorders Signs and Symptoms Taste Disorders Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

About this study

Gynecologic malignancies, including ovarian, fallopian tube, and endometrial cancers, are among the leading causes of morbidity and mortality in women. Standard first-line treatment with carboplatin and paclitaxel improves survival but can cause adverse effects such as dysgeusia (taste alteration), weight loss, sarcopenia, and malnutrition. Chemotherapy-induced dysgeusia may reduce oral intake, alter dietary preferences, and worsen protein-energy malnutrition, accelerating muscle loss and functional decline. Sarcopenia and myosteatosis, assessed using CT-based SMI measurements at the L3 vertebra, have been shown to affect chemotherapy tolerance and prognosis.

This single-center observational study at Ankara Etlik City Hospital enrolled 102 female patients with non-metastatic ovarian, fallopian tube, or endometrial cancer undergoing six cycles of carboplatin-paclitaxel. Systematic evaluations included CITAS, PG-SGA, CT-based SMI, Eastern Cooperative Oncology Group (ECOG) performance status (range 0-5; higher scores indicate worse functional status), laboratory parameters, and anthropometric measures.

Primary objectives:

Incidence and severity of chemotherapy-induced taste alterations

Changes in nutritional status (PG-SGA)

Changes in skeletal muscle index (SMI)

Secondary objectives:

Correlation between CITAS and PG-SGA scores with dietary intake and chemotherapy adherence

Correlation between sarcopenia/malnutrition and chemotherapy-related toxicities (hematologic toxicities, fatigue)

Changes in ECOG performance status and functional capacity

Exploratory: correlations with inflammatory markers (C-reactive protein [CRP], albumin)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed diagnosis of non-metastatic ovarian, fallopian tube, or endometrial cancer
  • Planned to receive adjuvant or neoadjuvant carboplatin-paclitaxel regimen (carboplatin AUC 5 + paclitaxel 175-200 mg/m² every 21 days)
  • No prior chemotherapy
  • Age ≥ 18 years, female
  • Completion of 6 cycles of carboplatin-paclitaxel treatment
  • Availability of CT imaging at baseline, after third cycle, and after sixth cycle
  • Ability to provide written informed consent

Exclusion criteria

  • Metastatic disease or palliative treatment setting
  • Treatment with regimens other than carboplatin-paclitaxel or weekly protocols
  • Prior systemic therapy (e.g., immunotherapy, targeted therapy) Initial treatment discontinuation due to progression, toxicity, or patient preference
  • Missing CT imaging at required timepoints
  • Pregnancy or breastfeeding
  • Cognitive impairment or inability to provide informed consent
  • Severe comorbid conditions (e.g., uncontrolled cardiac disease, end-stage renal failure, advanced liver failure)
  • Inability to comply with study assessments or follow-up visits

Treatment and study plan

Standard Chemotherapy (Carboplatin-Paclitaxel)

Other

Standard-of-care chemotherapy with carboplatin (AUC 5, every 21 days) and paclitaxel (175-200 mg/m², every 21 days) for six cycles. No additional drugs, dose modifications, or alternative regimens introduced.

Primary outcomes

  1. Incidence and severity of chemotherapy-induced taste alterations

    Time frame: Baseline (before chemotherapy), at the end of Cycle 3 (each cycle is 21 days, ~9 weeks), and at the end of Cycle 6 (each cycle is 21 days, ~18 weeks).

    Chemotherapy-Induced Taste Alteration Scale (CITAS, Turkish validated). Range: 18-90; higher scores = greater severity of dysgeusia. Cut-offs: 18-30 = minimal, 31-60 = moderate, 61-90 = severe.

  2. Change in skeletal muscle index (SMI) at L3 vertebra level

    Time frame: Baseline (before chemotherapy), at the end of Cycle 3 (each cycle is 21 days, ~9 weeks), and at the end of Cycle 6 (each cycle is 21 days, ~18 weeks).

    CT-based skeletal muscle area at L3, normalized for height (cm²/m²). Cut-offs: Female <38.5 cm²/m², Male <52.4 cm²/m² define sarcopenia.

  3. Change in nutritional status measured by PG-SGA

    Time frame: Baseline (before chemotherapy), at the end of Cycle 3 (each cycle is 21 days, ~9 weeks), and at the end of Cycle 6 (each cycle is 21 days, ~18 weeks).

    Patient-Generated Subjective Global Assessment (PG-SGA, Turkish validated). Range: 0-35; higher = worse nutritional status. Cut-offs: 0-1 = no intervention, 2-3 = education, ≥4 = intervention, ≥9 = intensive support.

Secondary outcomes

  1. Impact of taste alterations on nutritional intake and treatment adherence

    Time frame: Baseline (before chemotherapy), at the end of Cycle 3 (each cycle is 21 days, ~9 weeks), and at the end of Cycle 6 (each cycle is 21 days, ~18 weeks).

    Correlation between CITAS scores (18-90; higher = worse dysgeusia) and PG-SGA scores (0-35; higher = worse nutritional status) with appetite changes, dietary preferences, and completion of planned chemotherapy cycles.

  2. Association between sarcopenia/malnutrition and chemotherapy-related toxicities

    Time frame: Throughout chemotherapy (baseline to end of Cycle 6, each cycle is 21 days, ~18 weeks).

    Correlation of CT-based SMI (Female <38.5, Male <52.4) and PG-SGA (0-35) with toxicities: neutropenia, anemia, thrombocytopenia, fatigue.

  3. Change in ECOG performance status and functional capacity

    Time frame: Baseline (before chemotherapy), at the end of Cycle 3 (each cycle is 21 days, ~9 weeks), and at the end of Cycle 6 (each cycle is 21 days, ~18 weeks).

    Eastern Cooperative Oncology Group (ECOG) performance status. Range: 0-5; higher = worse performance. Cut-offs: 0 = fully active, 1 = restricted, 2 = ambulatory, 3 = limited self-care, 4 = disabled, 5 = death.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Prospective Evaluation of Chemotherapy-Induced Taste Alterations, Sarcopenia, and Malnutrition in Patients With Gynecologic Malignancies Treated With Carboplatin and Paclitaxel

Acronym: GYM-TASTE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

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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