Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-02 @ 1:10 AM
Study NCT ID:
NCT07154966
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2025-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taste Alteration, Sarcopenia, and Malnutrition in Gynecologic Cancer Patients Receiving Carboplatin-Paclitaxel Chemotherapy
Sponsor:
Ankara Etlik City Hospital
Organization:
Study Overview
Official Title:
Prospective Evaluation of Chemotherapy-Induced Taste Alterations, Sarcopenia, and Malnutrition in Patients With Gynecologic Malignancies Treated With Carboplatin and Paclitaxel
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GYM-TASTE
Brief Summary:
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.
Detailed Description:
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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AEŞH-EK-2025-122 | OTHER | Ankara Etlik City Hospital Clinical Research Ethics Committee | View |