Overview

This trial is active, not recruiting.

Conditions breast cancer, fatigue, sleep disorders
Treatments cognitive assessment, fatigue assessment and management, psychological distress, quality of life and insomnia
Phase phase 3
Sponsor International Breast Cancer Study Group
Collaborator National Cancer Institute (NCI)
Start date December 2007
End date June 2016
Trial size 357 participants
Trial identifier NCT00659373, ANZ0701, CALGB-IBCSG-24-02-ANZ0701, CDR0000594003, IBCSG-24-02-ANZ0701

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients treated with tamoxifen for 5 years after randomization.
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.
(Experimental)
Patients receiving triptorelin for ovarian function suppression and treated with tamoxifen for 5 years after randomization.
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.
(Experimental)
Patients receiving triptorelin for ovarian function suppression and treated with exemestane for 5 years after randomization.
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.

Primary Outcomes

Measure
Changes in cognitive function over 1 year in premenopausal breast cancer patients who receive adjuvant tamoxifen with or without ovarian function suppression (OFS)
time frame: 1 year after patient randomization

Secondary Outcomes

Measure
The effect of tamoxifen with OFS versus exemestane with OFS on cognitive function over 1 year
time frame: 1 year after patient randomization
The effect of tamoxifen alone versus exemestane with OFS on cognitive function over 1 year
time frame: 1 year after patient randomization
Comparison of changes in cognitive function over 5 years and 6 years
time frame: 5 and 6 years after patient randomization
Impact of receiving prior chemotherapy or not on changes in cognitive function
time frame: 6 years after patient randomization
The relationship between subjective and objective cognitive function
time frame: 6 years after patient randomization
The relationship between cognitive function, psychological distress, fatigue, insomnia, and quality of life
time frame: 6 years after patient randomization

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by International Breast Cancer Study Group.