Ovarian Cancer (OvCa)GYM-TASTENCT07154966
Taste Alteration, Sarcopenia, and Malnutrition in Gynecologic Cancer Patients Receiving Carboplatin-Paclitaxel Chemotherapy
An observational study of Ovarian Cancer (OvCa) and Fallopian Tube Cancers, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer (OvCa), Fallopian Tube Cancers, Endometrial Cancer
- What is being tested?
- Standard Chemotherapy (Carboplatin-Paclitaxel)
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06210
About this study
Official title: Prospective Evaluation of Chemotherapy-Induced Taste Alterations, Sarcopenia, and Malnutrition in Patients With Gynecologic Malignancies Treated With Carboplatin and Paclitaxel
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.
Read the 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)
- Conditions
- Ovarian Cancer (OvCa), Fallopian Tube Cancers, Endometrial Cancer, Chemotherapy-Induced Taste Alteration, Cancer-Associated Malnutrition, Cancer-Associated Sarcopeni
- Being tested
- Standard Chemotherapy (Carboplatin-Paclitaxel)
- Keywords
- Gynecologic malignancies, Ovarian cancer, Fallopian tube cancer, Endometrial cancer, Chemotherapy, Taste alteration (dysgeusia), Malnutrition, Sarcopenia, PG-SGA, CITAS, Supportive oncology
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Endometrial Neoplasms, Dysgeusia, Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard Chemotherapy (Carboplatin-Paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start15 Mar 2024
- Primary completion10 Jan 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer (OvCa)Studies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
- Investigators
- Galip Can Uyar, MD, Principal investigator, Ankara Etlik City Hospital Medical Oncology DepartmentOsman Sütcüoğlu, MD, Principal investigator, Gazi University Medical Oncology Department, AnkaraÖmür Berna Öksüzoğlu, MD, Principal investigator, Ankara Etlik City Hospital Medical Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154966
- Sponsor's protocol ID
- AEŞH-EK-2025-122
- Other IDs
- AEŞH-EK-2025-122
- Acronym
- GYM-TASTE
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Chemotherapy-Induced Taste Alterations, Sarcopenia, and Malnutrition in Patients With Gynecologic Malignancies Treated With Carboplatin and Paclitaxel
- ClinicalTrials.gov ID
- NCT07154966
- Acronym / sponsor ID
- GYM-TASTE / AEŞH-EK-2025-122
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin-Paclitaxel Cohort | – | Other: Standard Chemotherapy (Carboplatin-Paclitaxel)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Carboplatin-Paclitaxel Cohort |
Primary outcome
Incidence and severity of chemotherapy-induced taste alterations
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).
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.
Change in skeletal muscle index (SMI) at L3 vertebra level
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).
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.
Change in nutritional status measured by PG-SGA
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).
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.
3 secondary outcomes
Impact of taste alterations on nutritional intake and treatment adherence
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
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galip Can Uyar, MD principal investigator
Ankara Etlik City Hospital Medical Oncology Department
Osman Sütcüoğlu, MD principal investigator
Gazi University Medical Oncology Department, Ankara
Ömür Berna Öksüzoğlu, MD principal investigator
Ankara Etlik City Hospital Medical Oncology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer (OvCa) and Fallopian Tube Cancers, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of chemotherapy-induced taste alterations (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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.