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

Completed

Conditions studied: Cognitive Side Effects of Cancer Therapy, Malignant Ovarian Epithelial Tumor, Ovarian Brenner Tumor, Ovarian Carcinosarcoma, Ovarian Choriocarcinoma, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Dysgerminoma, Ovarian Embryonal Carcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Germ Cell Tumor, Ovarian Mucinous Cystadenocarcinoma, Ovarian Polyembryoma, Ovarian Sarcoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Teratoma, Ovarian Yolk Sac Tumor, Stage I Ovarian Cancer, Stage IA Fallopian Tube Cancer, Stage IA Ovarian Cancer, Stage IA Ovarian Germ Cell Tumor, Stage IB Fallopian Tube Cancer, Stage IB Ovarian Cancer, Stage IB Ovarian Germ Cell Tumor, Stage IC Fallopian Tube Cancer, Stage IC Ovarian Cancer, Stage IC Ovarian Germ Cell Tumor, Stage II Ovarian Cancer, Stage IIA Fallopian Tube Cancer, Stage IIA Ovarian Cancer, Stage IIA Ovarian Germ Cell Tumor, Stage IIB Fallopian Tube Cancer, Stage IIB Ovarian Cancer, Stage IIB Ovarian Germ Cell Tumor, Stage IIC Fallopian Tube Cancer, Stage IIC Ovarian Cancer, Stage IIC Ovarian Germ Cell Tumor, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Ovarian Germ Cell Tumor, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Ovarian Germ Cell Tumor, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Ovarian Germ Cell Tumor, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Primary Peritoneal Cancer, Undifferentiated Ovarian Carcinoma

In brief

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.

Key facts

Study ID

NCT01080521

Run by

Gynecologic Oncology Group

People needed

247

Starts

2010-04-01

Expected to finish

2018-01-27

Last updated by the study team

2018-04-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Roy and Patricia Disney Family Cancer Center — Burbank, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California, United States
• University of California San Diego — San Diego, California, United States
• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• John B Amos Cancer Center — Columbus, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• Elkhart Clinic — Elkhart, Indiana, United States
• Michiana Hematology Oncology PC-Elkhart — Elkhart, Indiana, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Community Howard Regional Health — Kokomo, Indiana, United States
• IU Health La Porte Hospital — La Porte, Indiana, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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