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
This study is currently recruiting participants.
Verified October 2011 by National Cancer Institute (NCI)
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01080521
First received: March 3, 2010
Last updated: December 7, 2011
Last verified: October 2011
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Purpose
RATIONALE: Learning about the effects of chemotherapy on brain function may help doctors plan cancer treatments.
PURPOSE: 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.
| Condition | Intervention |
|---|---|
|
Cognitive/Functional Effects Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: systemic chemotherapy Other: questionnaire administration Procedure: assessment of therapy complications Procedure: cognitive assessment Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Official Title: | A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To describe changes in cognitive function among patients with ovarian, primary peritoneal, or fallopian tube cancer receiving front-line chemotherapy as measured by a web-based assessment of cognitive function as measured by the HeadMinder Customized Research Tool (CRT).
Secondary
- To estimate the proportion of these patients who experience possible or probable acute or persistent impairment in cognitive function while receiving chemotherapy as measured by a web-based assessment of cognitive function as measured by the HeadMinder CRT.
- To explore the association between the patient-reported neurocognitive function as measured by the Patient Assessment of Own Functioning (PAF) scale and web-based assessment of cognitive function as measured by the HeadMinder CRT.
Tertiary
- To explore the relationship between patient-reported quality of life as measured by the FACT-O and cognitive function as measured by the web-based and patient-reported assessments, respectively. (Exploratory)
- To explore whether the patient-reported cognitive function or the web-based assessment of cognitive function is associated with anxiety and depression as measured by the Hospital Anxiety and Depression Scale. (Exploratory)
- To explore the changes in cognitive function using the web-assessed (CRT) and self-reported (PAF) assessments, respectively, among patients with advanced ovarian cancer (stage III-IV, optimally debulked disease at enrollment) receiving IV as compared to intraperitoneal treatment. (Exploratory)
- To explore whether the cognitive impairment as measured with web-based assessment is associated with patient age, hemoglobin, platelet count, patient-reported neurotoxicity symptoms as measured with FACT/GOG-Ntx subscale, or body weight. (Exploratory)
OUTLINE: This is a multicenter study.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy or chemotherapy
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080521
Show 164 Study Locations
Show 164 Study LocationsSponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Study Chair: | Lisa M. Hess, PhD | Indiana University School of Medicine |
| Investigator: | David S. Alberts, MD | University of Arizona |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01080521 History of Changes |
| Other Study ID Numbers: | CDR0000666786, GOG-0256 |
| Study First Received: | March 3, 2010 |
| Last Updated: | December 7, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
cognitive/functional effects ovarian sarcoma ovarian stromal cancer Brenner tumor ovarian carcinosarcoma ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma ovarian choriocarcinoma ovarian dysgerminoma ovarian embryonal carcinoma ovarian mixed germ cell tumor |
ovarian polyembryoma ovarian teratoma ovarian yolk sac tumor stage IA ovarian epithelial cancer stage IB ovarian epithelial cancer stage IC ovarian epithelial cancer stage IIA ovarian epithelial cancer stage IIB ovarian epithelial cancer stage IIC ovarian epithelial cancer stage IIIA ovarian epithelial cancer stage IIIB ovarian epithelial cancer stage IIIC ovarian epithelial cancer stage IV ovarian epithelial cancer stage IA ovarian germ cell tumor stage IB ovarian germ cell tumor |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on May 16, 2013