Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by City of Hope Medical Center
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01030250
First received: December 9, 2009
Last updated: October 16, 2014
Last verified: October 2014

December 9, 2009
October 16, 2014
July 2009
July 2018   (final data collection date for primary outcome measure)
Describe longitudinal trajectory of physical functional status and quality of life and determine if the patient assessment measure predicts morbidity in adult breast cancer patients from prior to adjuvant chemotherapy to 6 months after end of treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01030250 on ClinicalTrials.gov Archive Site
Assess potential biomarkers for physiologic age, including Advanced Glycation Endproducts (AGEs) and markers for oxidative stress and inflammation (e.g. 8-OHdG). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life
Adjuvant Therapy in Older Versus Younger Women With Breast Cancer: Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life

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.

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)

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and Urine to be collected prior to commencement of chemotherapy

Non-Probability Sample

Patients with breast cancer receiving adjuvant chemotherapy at City of Hope Medical Center

Breast Cancer
Not Provided
  • Under 65 years
    Breast cancer patients receiving adjuvant chemotherapy. Those under 65 years of age will be prospectively evaluated for outcome.
  • Over 65 years
    Breast cancer patients receiving adjuvant chemotherapy. Those over 65 years of age will be prospectively evaluated for outcome.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2018
July 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with stages I-III breast cancer receiving adjuvant chemotherapy
  2. Able to understand English
  3. Able to provide informed consent
  4. Patients of any age and performance status are eligible
Both
18 Years and older
No
Contact: Arti Hurria, MD 626 256-4673 ext 64173 ahurria@coh.org
Contact: Laura Zavala 626 256-4673
United States
 
NCT01030250
08242
Yes
City of Hope Medical Center
City of Hope Medical Center
Not Provided
Principal Investigator: Arti Hurria, MD City of Hope Medical Center
City of Hope Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP