Clinical trial · Observational
Changes in Brain Function in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy
A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer
NCT01080521CI-TRIAL-00032495completedClinicalTrials.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)
This clinical trial is studying changes in brain function in patients with stage I, stage II, stage III, or stage IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy. Learning about the effects of chemotherapy on brain function may help doctors plan cancer treatments.
Conditions
Conditions (54)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Side Effects of Cancer Therapy | — | UNRESOLVED | — |
| Malignant Ovarian Epithelial Tumor | Malignant Ovarian Epithelial Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Brenner Tumor | Ovarian Brenner Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Carcinosarcoma | Ovarian Carcinosarcoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Choriocarcinoma | Ovarian Choriocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Clear Cell Cystadenocarcinoma | Ovarian Clear Cell Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Dysgerminoma | Ovarian Dysgerminoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Embryonal Carcinoma | Ovarian Embryonal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Endometrioid Adenocarcinoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Assessment | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (cognitive function during chemotherapy)
- description
- Patients receive standard chemotherapy. Treatment repeats for 6 courses. Patients complete neurocognitive evaluations (Patient Assessment and Own Functioning scale and HeadMinder Custom Research Tool) and quality-of-life assessments (Hospital Anxiety and Depression Scale, FACT-O, and FACT/GOG-Ntx subscale) at baseline, before the fourth course of chemotherapy, at 3 weeks after the sixth course of chemotherapy, and at 6 months after the sixth course of chemotherapy.
- interventionNames
- Procedure: Cognitive Assessment
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
- Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
- timeFrame
- Up to 6 months after completion of chemotherapy
Secondary outcomes (1)
- measure
- Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or pathologically confirmed primary diagnosis of stage I-IV ovarian, primary peritoneal, or fallopian tube cancer (any cell type) * Planning to receive ≥ 6 courses of front-line chemotherapy * Have not yet received the first course of chemotherapy * GOG performance status 0-2 * Able to read and understand English * No uncontrolled or severe cardiovascular disease, including any of the following: * Myocardial infarction within the past year * Uncontrolled hypertension * Congestive heart failure * No history of head injury with GCS \< 13 * No severe hemiparesis or other condition preventing bimanual keyboard operation * No distal neuropathy, action tremor, or other motor dysfunction that would substantially decrease keyboard accuracy * No severe motor or mental slowing (i.e., patient who is disoriented/level C on any criterion as assessed by the person-place-time criteria) * No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer * More than 6 months since prior epoetin alfa, darbepoetin, or any investigational forms of erythropoietin * Patients may receive these agents during chemotherapy treatment as needed * No prior radiotherapy or chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.