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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Australian New Zealand Breast Cancer Trials Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00659373
First received: April 15, 2008
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Fatigue
Sleep Disorders
Procedure: cognitive assessment
Procedure: fatigue assessment and management
Procedure: Psychological distress
Procedure: Quality of Life and insomnia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers

Resource links provided by NLM:


Further study details as provided by International Breast Cancer Study Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effect of tamoxifen with OFS versus exemestane with OFS on cognitive function over 1 year [ Time Frame: 1 year after patient randomization ] [ Designated as safety issue: No ]
  • The effect of tamoxifen alone versus exemestane with OFS on cognitive function over 1 year [ Time Frame: 1 year after patient randomization ] [ Designated as safety issue: No ]
  • Comparison of changes in cognitive function over 5 years and 6 years [ Time Frame: 5 and 6 years after patient randomization ] [ Designated as safety issue: No ]
  • Impact of receiving prior chemotherapy or not on changes in cognitive function [ Time Frame: 6 years after patient randomization ] [ Designated as safety issue: No ]
  • The relationship between subjective and objective cognitive function [ Time Frame: 6 years after patient randomization ] [ Designated as safety issue: No ]
  • The relationship between cognitive function, psychological distress, fatigue, insomnia, and quality of life [ Time Frame: 6 years after patient randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 357
Study Start Date: December 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tamoxifen without OFS
Patients treated with tamoxifen for 5 years after randomization.
Procedure: cognitive assessment
Cognitive function will be evaluated using the CogState Questionnaire, the Cognitive Failures Questionnaire (subjective cognitive function) and the General Health Questionnaire.
Procedure: fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
Procedure: Psychological distress
Psychological distress will be evaluated using the General Health Questionnaire.
Procedure: 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: OFS plus tamoxifen
Patients receiving triptorelin for ovarian function suppression and treated with tamoxifen for 5 years after randomization.
Procedure: cognitive assessment
Cognitive function will be evaluated using the CogState Questionnaire, the Cognitive Failures Questionnaire (subjective cognitive function) and the General Health Questionnaire.
Procedure: fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
Procedure: Psychological distress
Psychological distress will be evaluated using the General Health Questionnaire.
Procedure: 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: OFS plus exemestane
Patients receiving triptorelin for ovarian function suppression and treated with exemestane for 5 years after randomization.
Procedure: cognitive assessment
Cognitive function will be evaluated using the CogState Questionnaire, the Cognitive Failures Questionnaire (subjective cognitive function) and the General Health Questionnaire.
Procedure: fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
Procedure: Psychological distress
Psychological distress will be evaluated using the General Health Questionnaire.
Procedure: 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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659373

Locations
United States, California
Mercy General Hospital
Sacramento, California, United States, 95819
United States, Colorado
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
United States, New York
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Sponsors and Collaborators
International Breast Cancer Study Group
Australian New Zealand Breast Cancer Trials Group
Cancer and Leukemia Group B
Investigators
Study Chair: Juerg Bernhard, PhD International Breast Cancer Study Group
Study Chair: Kelly-Anne Phillips Peter MacCallum Cancer Centre, Australia
Study Chair: Timothy Ahles, MD Cancer and Leukemia Group B
  More Information

Additional Information:
No publications provided

Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00659373     History of Changes
Other Study ID Numbers: CDR0000594003, IBCSG-24-02-ANZ0701, ANZ0701, CALGB-IBCSG-24-02-ANZ0701
Study First Received: April 15, 2008
Last Updated: November 1, 2013
Health Authority: United States: Federal Government
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: The Italian Medicines Agency
Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by International Breast Cancer Study Group:
cognitive/functional effects
psychosocial effects of cancer and its treatment
fatigue
sleep disorders
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Sleep Disorders
Parasomnias
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 23, 2014