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

March 18, 2024 updated by: City of Hope Medical Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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)

Study Type

Observational

Enrollment (Actual)

238

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Arti Hurria, MD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2009

Primary Completion (Actual)

August 14, 2019

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimated)

December 11, 2009

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08242
  • R03AG050931 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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