Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01030250 |
| Other study ID # |
08242 |
| Secondary ID |
R03AG050931 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 11, 2009 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
City of Hope Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this study is to increase our understanding of the adjuvant chemotherapy
experience in older and younger adults by prospectively describing the longitudinal
trajectory of functional status, comorbidity, and quality of life from before the initiation
of chemotherapy to 6 months after the completion of treatment in older (65 and older) and
younger (under 65) adults. In addition, we will determine the effect of pre-treatment
physical functioning on physical recovery after the course of adjuvant chemotherapy. The
secondary objective of this study is to explore if factors other than chronological age
(functional status, co-morbid medical conditions, nutritional status, psychological state,
cognitive function, and social support) predicts which patients are more likely to experience
morbidity (defined as grade 3-5 toxicity, hospitalization, dose reduction or delay, or
premature discontinuation of chemotherapy course) from adjuvant chemotherapy.
Description:
60% of all cancers and 70% of cancer mortality occur in people greater than 65 years of age,
defining cancer as a disease of older adults. Breast cancer is no exception to this rule
where almost half of all new breast cancers in the United States are diagnosed in women 65
years of age or older1. Despite the association between cancer and aging, treatment
recommendations and data acquired from prospective clinical trials in older women with breast
cancer are sparse. As a result, physicians and older adults have limited data to guide
treatment recommendation, make dose adjustments and manage toxicities in older adults. Aging
is invariably associated with changes in physiology which can impact the pharmacokinetics and
pharmacodynamics of cancer therapy. The potential for increased toxic effects in the older
patient becomes an important concern. Therefore, it may not be reasonable to extrapolate data
regarding toxicity from clinical trials, which primarily include younger, healthier patients.
In addition, the age-related impact of adjuvant therapy on the functional status and quality
of life of older versus younger adults has not been rigorously evaluated, and risk factors
for toxicity, other than chronological age, need to be studied among older adults receiving
anthracycline and non-anthracycline based chemotherapy regimens.
The goal of this study is to prospectively describe the longitudinal trajectory of functional
status, comorbidity, and quality of life from before the initiation of chemotherapy to 6
months after the completion of treatment in older (65 and older) and younger (under 65)
adults. We will determine the effect of pre-treatment physical functioning on physical
recovery (ie, physical function at end of chemotherapy and 6 months later) after the course
of adjuvant chemotherapy. In addition, we will explore if factors other than chronological
age (functional status, comorbid medical conditions, nutritional status, psychological state,
cognitive function, and social support) predict which patients are more likely to experience
treatment morbidity (defined as grade 3-5 toxicity, hospitalization or urgent care visits,
dose reduction or delay, or premature discontinuation of the planned chemotherapy course)
