An observational study in Ovarian Cancer (OvCa), Fallopian Tube Cancers and Endometrial Cancer, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Ankara Etlik City Hospital · Observational
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)
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's enrollment of 102 is below the median of 200 across 616 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Ankara Etlik City Hospital is the lead sponsor of 176 studies on the registry; 77 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Standard Chemotherapy (Carboplatin-Paclitaxel)
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.
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.
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).
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.
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).
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.
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).
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.
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).
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.
Time frame: 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.
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).
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Jan 2025, 9 months.
Of 216 non-industry observational studies under Ovarian Neoplasms, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 206. This study's 9 months is below that.
Counting every sponsor, half of 268 studies reached it within 61 months; a quarter within 35 and three quarters within 185.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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