Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01080521
First received: March 3, 2010
Last updated: August 8, 2014
Last verified: August 2014
  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
Brenner Tumor
Cognitive/Functional Effects
Ovarian Carcinosarcoma
Ovarian Choriocarcinoma
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Dysgerminoma
Ovarian Embryonal Carcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mixed Germ Cell Tumor
Ovarian Mucinous Cystadenocarcinoma
Ovarian Polyembryoma
Ovarian Sarcoma
Ovarian Serous Cystadenocarcinoma
Ovarian Stromal Cancer
Ovarian Teratoma
Ovarian Undifferentiated Adenocarcinoma
Ovarian Yolk Sac Tumor
Stage IA Fallopian Tube Cancer
Stage IA Ovarian Epithelial Cancer
Stage IA Ovarian Germ Cell Tumor
Stage IA Primary Peritoneal Cavity Cancer
Stage IB Fallopian Tube Cancer
Stage IB Ovarian Epithelial Cancer
Stage IB Ovarian Germ Cell Tumor
Stage IB Primary Peritoneal Cavity Cancer
Stage IC Fallopian Tube Cancer
Stage IC Ovarian Epithelial Cancer
Stage IC Ovarian Germ Cell Tumor
Stage IC Primary Peritoneal Cavity Cancer
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Epithelial Cancer
Stage IIA Ovarian Germ Cell Tumor
Stage IIA Primary Peritoneal Cavity Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Epithelial Cancer
Stage IIB Ovarian Germ Cell Tumor
Stage IIB Primary Peritoneal Cavity Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Epithelial Cancer
Stage IIC Ovarian Germ Cell Tumor
Stage IIC Primary Peritoneal Cavity Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Ovarian Germ Cell Tumor
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Ovarian Germ Cell Tumor
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Ovarian Germ Cell Tumor
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Ovarian Germ Cell Tumor
Stage IV Primary Peritoneal Cavity Cancer
Procedure: cognitive assessment
Other: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Case Control
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 249
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080521

  Show 182 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Lisa Hess Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01080521     History of Changes
Other Study ID Numbers: GOG-0256, NCI-2011-02213, GOG-0256, CDR0000666786, GOG-0256, GOG-0256, GOG-0256, U10CA101165
Study First Received: March 3, 2010
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 23, 2014