Cognitive Changes in Adult Cancer Survivors

NCT01569932 | Completed

• 1 other identifier: 201105082
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study will document the cognitive (mental) and functional abilities of newly diagnosed cancer patients. The study will also examine the changes in cognitive and functional abilities during and after chemotherapy (your cancer treatment). A comprehensive set of questionnaires and tasks, or assessments, have been put together in order for doctors and nurses to learn more about the day to day functioning of newly diagnosed adult cancer patients. The investigators would also like to follow up with the same adult patients, during and following completion of their cancer treatment, to learn about the kinds of treatments they received and how their cognitive status and level of participation in activities of daily living has changed. With follow-up assessments, doctors and nurses can learn more about the complications or health problems that adult patients may experience as a result of undergoing cancer therapy. This is a study involving two visits. The first visit occurs within two weeks before starting your cancer therapy, specifically chemotherapy. The second visit occurs within two weeks of completing your chemotherapy.

Conditions

Effects of Chemotherapy; Cognitive Impairment

Keywords

chemobrain, chemotherapy, cognitive impairments, fcMRI, neurocognitive Assessments

Outcome Measures

Primary Outcomes (1)

• Change in fcMRI

  Baseline and post-chemotherapy fcMRI maps will be compared for changes in degree of activation within the cognition-associated cortical networks. To compute statistical significance, correlation co-efficients from the fcMRI will be converted to a normal distribution using Fischer's r-to-z transformation.

  before and after chemotherapy

Secondary Outcomes (1)

• Correlation of change in fcMRI with change in neurocognitive test scores.

  Baseline and at the completion of chemotherapy. Baseline visit must be no more than 2 weeks prior to start of chemotherapy. 2nd visit must occur within 2 weeks of last dose of chemotherapy.

Study Arms (1)

chemotherapy

Patients will be assessed both before and after they undergo treatment with chemotherapy.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The final study population will include sixteen adults over the age of 40 years with newly-diagnosed locally-advanced breast, head and neck, ovarian, primary peritoneal, bladder , and urethral cancer although up to 25 patients will be approached for enrollment to account for losses to attrition.

You may qualify if:

• Subjects must be 40 years of age or older
• Subjects must be able to read, write and speak English fluently
• Treatment with a chemotherapy regimen that contains 5-fluorouracil or a platinum-based drug.
• Breast cancer subjects must be newly diagnosed with invasive lobular or ductal cancer (stages II and III)
• Head and Neck cancer subjects must be newly diagnosed with locally-advanced squamous cell carcinoma of the head and neck in oropharyngeal, hypopharyngeal and laryngeal sites (stages III and IV)
• Ovarian, fallopian tube, or primary peritoneal cancer subjects must be newly diagnosed with epithelial ovarian cancer (stages II - IV), fallopian tube cancer with pelvic extension (stages II-IV), or primary peritoneal cancer (stages III-IV)
• Bladder, renal pelvis, or ureteral cancer subjects must be newly-diagnosed with muscle-invasive cancer (stages II - IV).
• Urethral cancer subjects must be newly diagnosed with cancer invading the corpus spongiosum, prostate, or periurethral muscle (stages II-IV)
• Subjects must be anticipated to receive chemotherapy without the concomitant treatment use of hormonal therapy or immunomodulators.

You may not qualify if:

• Subjects with other prior cancer diagnoses who have evidence of active disease
• Subjects who have received chemotherapy or radiation treatment within the past year (for any disease state)
• Subjects with melanoma or other non-squamous cell carcinoma of the head and neck
• Subjects with nasopharyngeal, sinonasal or lateral skull base tumors. Unintentional cranial irradiation can occur with treatment to these sites and could therefore not be completely eliminated from being associated with any cognitive deficits observed.
• Subjects with implanted non-MRI compatible metal objects, electrodes, pacemakers, intracardiac lines, or medication pumps
• Subjects with weight over 350 pounds (weight limit on MRI machine)
• Subjects with a history of claustrophobia
• Subjects with an inability to lie flat for 20 minutes (for fcMRI scan)
• Life expectancy of less than 6 months
• Any medical condition the Principal Investigator (PI) determines would not make the study safe or in the best interest of the potential subject to participate in.
• Subjects who receive hormonal therapy therapy or immunomodulators as part of their cancer therapy.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Jay F Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology, Director of Clinical Outcomes Research Office

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: April 3, 2012
• Study Start: February 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

US (1)