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Clinical Trials/NCT01080521
NCT01080521
Completed
N/A

A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Gynecologic Oncology Group182 sites in 1 country247 target enrollmentApril 2010
ConditionsCognitive Side Effects of Cancer TherapyMalignant Ovarian Epithelial TumorOvarian Brenner TumorOvarian CarcinosarcomaOvarian ChoriocarcinomaOvarian Clear Cell CystadenocarcinomaOvarian DysgerminomaOvarian Embryonal CarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mixed Germ Cell TumorOvarian Mucinous CystadenocarcinomaOvarian PolyembryomaOvarian SarcomaOvarian Seromucinous CarcinomaOvarian Serous CystadenocarcinomaOvarian TeratomaOvarian Yolk Sac TumorStage I Ovarian CancerStage IA Fallopian Tube CancerStage IA Ovarian CancerStage IA Ovarian Germ Cell TumorStage IB Fallopian Tube CancerStage IB Ovarian CancerStage IB Ovarian Germ Cell TumorStage IC Fallopian Tube CancerStage IC Ovarian CancerStage IC Ovarian Germ Cell TumorStage II Ovarian CancerStage IIA Fallopian Tube CancerStage IIA Ovarian CancerStage IIA Ovarian Germ Cell TumorStage IIB Fallopian Tube CancerStage IIB Ovarian CancerStage IIB Ovarian Germ Cell TumorStage IIC Fallopian Tube CancerStage IIC Ovarian CancerStage IIC Ovarian Germ Cell TumorStage IIIA Fallopian Tube CancerStage IIIA Ovarian CancerStage IIIA Ovarian Germ Cell TumorStage IIIA Primary Peritoneal CancerStage IIIB Fallopian Tube CancerStage IIIB Ovarian CancerStage IIIB Ovarian Germ Cell TumorStage IIIB Primary Peritoneal CancerStage IIIC Fallopian Tube CancerStage IIIC Ovarian CancerStage IIIC Ovarian Germ Cell TumorStage IIIC Primary Peritoneal CancerStage IV Fallopian Tube CancerStage IV Ovarian CancerStage IV Ovarian Germ Cell TumorStage IV Primary Peritoneal CancerUndifferentiated Ovarian Carcinoma

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognitive Side Effects of Cancer Therapy
Sponsor
Gynecologic Oncology Group
Enrollment
247
Locations
182
Primary Endpoint
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE: I. 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 OBJECTIVES: I. 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. II. 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 OBJECTIVES: I. 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) II. 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) III. 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) IV. 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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
January 27, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)

Time Frame: Up to 6 months after completion of chemotherapy

Secondary Outcomes

  • Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT(Up to 6 months after completion of chemotherapy)

Study Sites (182)

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