Clinical trial · Interventional
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
NCT00905658CI-TRIAL-00002501unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment. PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard follow-up care | Procedure | — | UNRESOLVED |
| therapeutic nutritional supplementation | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Arm I
- description
- Patients are monitored via standard follow-up assessments every 3 weeks.
- interventionNames
- Procedure: standard follow-up care
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
- interventionNames
- Dietary Supplement: therapeutic nutritional supplementation
- Procedure: standard follow-up care
- type
- EXPERIMENTAL
- label
- Arm III
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed gynecological cancer * Currently receiving first-line chemotherapy for metastatic disease PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-2 or Karnofsky PS 70-100% * Not pregnant or nursing * Intake \< 75% of theoretical need * Weight loss ≥ 5% within the past 6 months * No patients with dementia or altered mental status * No psychological, familial, social, or geographic situations that preclude clinical follow up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.