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Completed

NCT Number: NCT01080521

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 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.

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Key information

Conditions

Cognitive Side Effects of Cancer Therapy Adnexal Diseases Brenner Tumor Dysgerminoma Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Germinoma Gonadal Disorders Malignant Ovarian Epithelial Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Ovarian Brenner Tumor Ovarian Carcinosarcoma Ovarian Choriocarcinoma Ovarian Clear Cell Cystadenocarcinoma Ovarian Diseases Ovarian Dysgerminoma Ovarian Embryonal Carcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mixed Germ Cell Tumor Ovarian Mucinous Cystadenocarcinoma Ovarian Neoplasms 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 Teratoma, Ovarian Undifferentiated Ovarian Carcinoma Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive assessment

Procedure

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

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

    Time frame: Up to 6 months after completion of chemotherapy

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2018
First posted
Mar 4, 2010
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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