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| ID | Type | Description | Link |
|---|---|---|---|
| AEÅžH-EK-2025-122 | Other Identifier | Ankara Etlik City Hospital Clinical Research Ethics Committee |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin-Paclitaxel Cohort | Patients with histologically confirmed non-metastatic ovarian, fallopian tube, or endometrial cancer receiving six cycles of standard carboplatin-paclitaxel chemotherapy (carboplatin AUC 5 + paclitaxel 175-200 mg/m² every 21 days). Assessments at baseline (before chemotherapy), after Cycle 3 (~9 weeks), and after Cycle 6 (~18 weeks). Evaluations: CITAS, PG-SGA, CT-based SMI, ECOG performance status, laboratory parameters, anthropometrics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of chemotherapy-induced taste alterations | 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. | 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). |
| Change in skeletal muscle index (SMI) at L3 vertebra level | 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. | 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). |
| Change in nutritional status measured by PG-SGA | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of taste alterations on nutritional intake and treatment adherence | 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult female patients (≥18 years) with histologically confirmed non-metastatic ovarian, fallopian tube, or endometrial cancer who are receiving adjuvant or neoadjuvant carboplatin-paclitaxel chemotherapy at Ankara Etlik City Hospital. A total of 102 patients will be enrolled. Participants must have completed six cycles of standard chemotherapy and have available CT imaging at baseline, after the third cycle, and after the sixth cycle to allow prospective evaluation of taste alterations, nutritional status, and sarcopenia.
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| Name | Affiliation | Role |
|---|---|---|
| Galip Can Uyar, MD | Ankara Etlik City Hospital Medical Oncology Department | Principal Investigator |
| Osman Sütcüoğlu, MD | Gazi University Medical Oncology Department, Ankara | Principal Investigator |
| Ömür Berna Öksüzoğlu, MD | Ankara Etlik City Hospital Medical Oncology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Ankara | Yenimahalle | 06210 | Turkey (Türkiye) |
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| Association between sarcopenia/malnutrition and chemotherapy-related toxicities | Correlation of CT-based SMI (Female <38.5, Male <52.4) and PG-SGA (0-35) with toxicities: neutropenia, anemia, thrombocytopenia, fatigue. | Throughout chemotherapy (baseline to end of Cycle 6, each cycle is 21 days, ~18 weeks). |
| Change in ECOG performance status and functional capacity | 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. | 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). |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D016889 | Endometrial Neoplasms |
| D004408 | Dysgeusia |
| D044342 | Malnutrition |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D013651 | Taste Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| C053518 | CP protocol |
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