Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98

Breast Cancer Clinical Trial

Official title:

Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343616
• Other study ID #: CDR0000482396
• Secondary ID: IBCSG-18-98-CFSI
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2006
• Last updated: July 26, 2012
• Start date: April 2005
• Est. completion date: May 2009

Study information

• Verified date: July 2012
• Source: International Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer.

PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.

Description:

OBJECTIVES:

Primary

• Compare cognitive function in postmenopausal women with breast cancer who have received 5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98.

Secondary

• Compare cognitive function in patients who have received a single hormonal therapy for 5 years vs those who have received that same hormonal therapy for 3 years, having previously received an alternate hormonal therapy for 2 years.

• Compare improvement in cognitive function 1 year after cessation of adjuvant hormonal therapy.

• Compare changes in cognitive function in patients who have received prior adjuvant chemotherapy vs those who have not received adjuvant chemotherapy.

• Assess the relationship between objective and subjective measures of cognitive function, including specific cognitive domains.

• Assess the relationship between cognitive function and psychological distress, fatigue, and quality of life.

OUTLINE: This is a longitudinal, multicenter study.

Patients undergo cognitive function testing and complete self-reported questionnaires regarding cognitive ability, quality of life, fatigue, and psychosocial status during the fifth year of adjuvant hormonal therapy on protocol IBCSG-1-98 and then during the sixth year* (post randomization on protocol IBCSG-1-98) (i.e., after completion of adjuvant hormonal therapy).

NOTE: *Patients who receive extended letrozole, hormone replacement therapy, or other endocrine therapy beyond 5 years do not undergo the 6-year assessment.

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Enrolled in protocol IBCSG-1-98

• Must be in the fifth year of study treatment (i.e., still receiving tamoxifen or letrozole)

• No breast cancer recurrence or second malignancy

• Patients who received 2-4½ years of tamoxifen and have chosen to switch to letrozole to complete 5 years of treatment on protocol IBCSG-1-98 are not eligible

• Hormone receptor status

• Estrogen receptor- and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

• Female

• Postmenopausal

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No concurrent hormone replacement therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cognitive/Functional Effects
• Fatigue
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
• fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
• psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
• quality-of-life assessment
Quality of life will be assessed using global linear analogue self-assessment (LASA) indicators for physical well-being, mood, coping effort (PACIS), perceived social support and subjective health estimation.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	St. Vincent's Hospital - Melbourne	Fitzroy	Victoria
Australia	Cabrini Hospital	Malvern	Victoria
Australia	Institute of Oncology at Prince of Wales Hospital	Randwick	New South Wales
Belgium	Institut Jules Bordet	Brussels
Italy	European Institute of Oncology	Milan
New Zealand	Auckland City Hospital	Auckland
Switzerland	Universitaetsspital-Basel	Basel
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona
Switzerland	International Breast Cancer Study Group	Bern
Switzerland	Kantonsspital - St. Gallen	St. Gallen
United Kingdom	Ninewells Hospital	Dundee	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
International Breast Cancer Study Group

Countries where clinical trial is conducted

Australia,  Belgium,  Italy,  New Zealand,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective cognitive function as measured by the CogState battery		6 years after randomization	No
Secondary	Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)		6 years after randomization	No
Secondary	Psychological distress as measured by the General Health Questionnaire (GHQ)		6 years after randomization	No
Secondary	Fatigue as measured by the Brief Fatigue Inventory (BFI)		6 years after randomization	No
Secondary	Quality of life as measured by the IBCSG QL Core Form		6 years after randomization	No