Cognitive Impact of Neoadjuvant Chemotherapy for Gynecologic Cancers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
The purpose of this research is to assess several components of cognition in patients recently diagnosed with advanced epithelial ovarian cancer and who will be undergoing neoadjuvant chemotherapy for treatment of the cancer. 18 participants will be enrolled and can expect to be on study for approximately 10 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Pathological diagnosis of suspected epithelial ovarian cancer; of note, patients with suspected epithelial ovarian cancer who are pending a pathological diagnosis/biopsy may be enrolled onto the study ahead of their biopsy. If the biopsy result is later inconsistent with epithelial ovarian cancer, they will be removed from the study and replaced
Planned to received neoadjuvant chemotherapy with carboplatin and paclitaxel; alternatives to these agents including abraxane, docetaxel, cisplatin may be used if patients have a chemotherapy reaction or otherwise cannot receive carboplatin and paclitaxel per usual standard of care
Patients may be receiving bevacizumab and may receive PARP inhibitors as a maintenance treatment; those receiving any other targeted therapy will be excluded
Disqualifiers
History of diagnosed cognitive impairment, including dementia
History of traumatic brain injury
English is not their primary language
Known hearing or visual impairment not corrected with hearing devices and glasses/contacts
Trial population
Participants scheduled to receive neoadjuvant chemotherapy for treatment of ovarian cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patient Reported Outcomes Assessment
Other interventionFunctional Assessment of Cancer Therapy - Ovarian (FACT-O) and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess patient reported outcomes.
Cognitive and General Health Assessments
Other intervention* Rey Verbal Learning Test * Trail Making Test * Patient Health Questionnaire (PHQ-2) * Mini Mental State Exam (MMSE) * Controlled Oral Word Association Test of the Multilingual Aphasia Examination
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Receiving Neoadjuvant Chemotherapy for Ovarian Cancer2 interventions
Trial outcomes
Primary outcomes
1
The Mini Mental State Exam (MMSE)
The MMSE is a common overall test of cognition used in research and clinical settings. It is an 11 item test that assesses five domains of cognition: orientation, registration, attention, recall and language. This measure takes around 5-10 minutes to complete and is scored out of 30 with scores of 18-23 representing mild cognitive impairment and scores of 17 or less representing severe cognitive impairment.
Time frame
baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)Secondary outcomes
1
Controlled Oral Word Association Test (COWAT)
Participant is asked to list as many words (other than people's names or places) beginning with a specific letter as they can in one minute. Number of unique words that qualify are counted.
Time frame
baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)2
Trail Making Test (TMT) Parts A and B
The TMT is a test of complex attention. Part A asks participants to connect circles on a page containing the numbers 1-25 in ascending order. Part B asks participants to connect circles containing the numbers 1-13 and the letters A-L in alternating ascending order (eg: 1, A, 2, B, etc). These tests are timed and a participant's score is the amount of time it takes to complete the entire task for each part; errors do not incur a score penalty but contribute to the overall time to complete the task. This takes approximately 5-10 minutes to complete
Time frame
baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)3
Patient Health Questionnaire-2 (PHQ-2)
The PHQ2 is a two item screening test that asks about the frequency of depressed mood and anhedonia over the past two weeks. Subjects whose answers receive a score of three or greater (on a scale of 0-6) are considered to be at risk for depression and should undergo further evaluation. This screening test takes around one minute to administer.
Time frame
baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)4
Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
The FACT-O is a validated and commonly used quality of life assessment utilized in many clinical research studies that assess 39 items/symptoms common amongst cancer patients generally with items included that are specifically common amongst ovarian cancer patients, including questions related to gastrointestinal symptoms and sexual health. Total scores range from 0 - 156 with higher scores indicative of better quality of life.
Time frame
baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)Sponsors and contacts
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Source ClinicalTrials.gov