Taste Alteration, Sarcopenia, and Malnutrition in Gynecologic Cancer Patients Receiving Carboplatin-Paclitaxel Chemotherapy (GYM-TASTE)

Ankara Etlik City Hospital

Status: Completed

Conditions: Endometrial Cancer; Fallopian Tube Cancers; Ovarian Cancer (OvCa); Cancer-Associated Sarcopeni; Cancer-Associated Malnutrition; Chemotherapy-Induced Taste Alteration

Treatments: Other: Standard Chemotherapy (Carboplatin-Paclitaxel)

Study type: Observational

Funder types: Other

Identifiers

NCT07154966

AEŞH-EK-2025-122 (Other Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 102 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

102 participants in 1 patient group

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.

Treatment:

Other: Standard Chemotherapy (Carboplatin-Paclitaxel)