Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02

Breast Cancer Clinical Trial

— Co-SOFT  

Official title:

Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00659373
• Other study ID #: CDR0000594003
• Secondary ID: IBCSG-24-02-ANZ0
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 15, 2008
• Last updated: November 1, 2013
• Start date: December 2007
• Est. completion date: June 2016

Study information

• Verified date: November 2013
• Source: International Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentSpain: Agencia Española de Medicamentos y Productos SanitariosItaly: The Italian Medicines AgencySwitzerland: SwissmedicGermany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Learning about the long-term effects of tamoxifen and ovarian function suppression on brain function may help doctors plan cancer treatment.

PURPOSE: This study is looking at brain function in premenopausal women who are receiving tamoxifen with or without ovarian function suppression for early-stage breast cancer on clinical trial IBCSG-2402.

Description:

OBJECTIVES:

Primary:

• To evaluate and compare changes in cognitive function over 1 year in premenopausal breast cancer patients who receive adjuvant tamoxifen with or without ovarian function suppression (OFS).

Secondary:

• To compare the effect of tamoxifen with OFS versus exemestane with OFS on cognitive function over 1 year.

• To compare the effect of tamoxifen alone versus exemestane with OFS on cognitive function over 1 year.

• To evaluate and compare changes in cognitive function over 5 years and 6 years between the 3 treatment groups (pending funding becoming available for the year 5 and 6 measures) on clinical trial IBCSG-2402.

• To explore the impact of receiving or not receiving prior chemotherapy on changes in cognitive function.

• To explore the relationship between subjective and objective cognitive function.

• To explore the relationship between cognitive function, psychological distress, fatigue, insomnia, and quality of life.

OUTLINE: This is a multicenter study.

Patients undergo objective cognitive function assessment over 20-25 minutes, using the CogState computerized test battery, which consists of five tasks that measure the speed of psychomotor function, visual attention, working memory and the accuracy of working memory, learning and memory and executive function (all non-verbal). They undergo subjective cognitive function assessment, using the Cognitive Failures Questionnaire (CFQ), a 25-item self-report measure that assesses a person's failures in memory, perception, and motor function over the past 6 months. Patients also complete General Health Questionnaire -12 (measuring psychologic distress), Brief Fatigue Inventory, NCI Common Terminology Criteria for Adverse Events, and a patient-rated linear analogue self-assessment (LASA) scale measuring insomnia. Patients complete these assessments at baseline (after registration to clinical trial IBCSG-2402, but before beginning protocol therapy) and at 1, 5, and 6 years after randomization on IBCSG-2402.

Relevant clinical factors, such as age, adjuvant chemotherapy, co-morbidity and concomitant medications are assessed. In addition, language, education, psychiatric and neurological history, alcohol consumption and right/left handedness are also assessed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 357
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Completely resected disease

• Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy

• Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:

• Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist

• Ovarian irradiation

• Bilateral oophorectomy

• Hormone receptor status:

• Estrogen and/or progesterone receptor positive

• Each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

• Premenopausal

• Can speak and read the local language(s) fluently

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue
• Parasomnias
• Sleep Disorders

Intervention

Procedure:
• cognitive assessment
Cognitive function will be evaluated using the CogState Questionnaire, the Cognitive Failures Questionnaire (subjective cognitive function) and the General Health Questionnaire.
• fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
• Psychological distress
Psychological distress will be evaluated using the General Health Questionnaire.
• Quality of Life and insomnia
QL and insomnia will be assessed using the QL Form, the QL module, NCI CATCAE version 3 and a patient-rated linear analogue self-assessment (LASA) scale.

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
Canada	Ottawa Hospital Regional Cancer Centre - General Campus	Ottawa	Ontario
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Northside Hospital Cancer Center	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Batte Cancer Center at Northeast Medical Center	Concord	North Carolina
United States	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	New York
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mercy General Hospital	Sacramento	California
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
International Breast Cancer Study Group	Australian New Zealand Breast Cancer Trials Group, Cancer and Leukemia Group B, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cognitive function over 1 year in premenopausal breast cancer patients who receive adjuvant tamoxifen with or without ovarian function suppression (OFS)		1 year after patient randomization	No
Secondary	The effect of tamoxifen with OFS versus exemestane with OFS on cognitive function over 1 year		1 year after patient randomization	No
Secondary	The effect of tamoxifen alone versus exemestane with OFS on cognitive function over 1 year		1 year after patient randomization	No
Secondary	Comparison of changes in cognitive function over 5 years and 6 years		5 and 6 years after patient randomization	No
Secondary	Impact of receiving prior chemotherapy or not on changes in cognitive function		6 years after patient randomization	No
Secondary	The relationship between subjective and objective cognitive function		6 years after patient randomization	No
Secondary	The relationship between cognitive function, psychological distress, fatigue, insomnia, and quality of life		6 years after patient randomization	No