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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080521
First Posted: March 4, 2010
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  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. Learning about the effects of chemotherapy on brain function may help doctors plan cancer treatments.

Condition Intervention
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 Procedure: Cognitive Assessment Other: Quality-of-Life Assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Gynecologic Oncology Group:

Primary Outcome Measures:
  • Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) [ Time Frame: Up to 6 months after completion of chemotherapy ]

Secondary Outcome Measures:
  • Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT [ Time Frame: Up to 6 months after completion of chemotherapy ]

Enrollment: 247
Study Start Date: April 2010
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational (cognitive function during chemotherapy)
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.
Procedure: Cognitive Assessment
Ancillary studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080521


  Show 182 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lisa Hess Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01080521     History of Changes
Other Study ID Numbers: GOG-0256
NCI-2011-02213 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000666786
GOG-0256 ( Other Identifier: Gynecologic Oncology Group )
GOG-0256 ( Other Identifier: DCP )
GOG-0256 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Submitted: March 3, 2010
First Posted: March 4, 2010
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Adenocarcinoma
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Germinoma
Teratoma
Carcinoma, Embryonal
Endodermal Sinus Tumor
Choriocarcinoma
Cystadenocarcinoma
Carcinoma, Endometrioid
Carcinosarcoma
Mixed Tumor, Mullerian
Cystadenocarcinoma, Serous
Cystadenocarcinoma, Mucinous
Brenner Tumor
Dysgerminoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases


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