Taste Alteration, Sarcopenia, and Malnutrition in Gynecologic Cancer Patients Receiving Carboplatin-Paclitaxel Chemotherapy

NCT07154966 | Completed

• 1 other identifier: AEŞH-EK-2025-122
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gynecologic malignancies; Ovarian cancer; Fallopian tube cancer; Endometrial cancer; Chemotherapy; Taste alteration (dysgeusia); Malnutrition; Sarcopenia; PG-SGA; CITAS; Supportive oncology

Outcome Measures

Primary Outcomes (3)

• 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).

Secondary Outcomes (3)

• Impact of taste alterations on nutritional intake and treatment adherence

  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

  Throughout chemotherapy (baseline to end of Cycle 6, each cycle is 21 days, ~18 weeks).

• Change in ECOG performance status and functional capacity

  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).

Study Arms (1)

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.

Other: Standard Chemotherapy (Carboplatin-Paclitaxel)

Interventions

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.

Carboplatin-Paclitaxel Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Endometrial Neoplasms; Dysgeusia; Malnutrition; Sarcopenia

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Uterine Neoplasms; Uterine Diseases; Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Atrophy; Pathological Conditions, Anatomical

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 4, 2025
• Study Start: March 15, 2024
• Primary Completion: January 10, 2025
• Study Completion: July 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)