Clinical trial · Observational
Taste Alteration, Sarcopenia, and Malnutrition in Gynecologic Cancer Patients Receiving Carboplatin-Paclitaxel Chemotherapy
Prospective Evaluation of Chemotherapy-Induced Taste Alterations, Sarcopenia, and Malnutrition in Patients With Gynecologic Malignancies Treated With Carboplatin and Paclitaxel
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-Associated Malnutrition | — | UNRESOLVED | — |
| Cancer-Associated Sarcopeni | — | UNRESOLVED | — |
| Chemotherapy-Induced Taste Alteration | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancers | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer (OvCa) | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Chemotherapy (Carboplatin-Paclitaxel) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Carboplatin-Paclitaxel Cohort
- description
- 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.
- interventionNames
- Other: Standard Chemotherapy (Carboplatin-Paclitaxel)
Primary outcomes (3)
- measure
- Incidence and severity of chemotherapy-induced taste alterations
- timeFrame
- 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).
- description
- 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.
- measure
- Change in skeletal muscle index (SMI) at L3 vertebra level
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available