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Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults

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ClinicalTrials.gov Identifier: NCT01472094
Recruitment Status : Active, not recruiting
First Posted : November 16, 2011
Last Update Posted : June 15, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
The goal of this study is to develop a "bedside to bench" model of clinical and biological predictors for toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast cancer. The investigators will develop a predictive model using clinical and biological predictors of toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast cancer. The investigators will also determine the association between clinical and biological factors and reduced relative dose intensity of the prescribed chemotherapy regimen. In addition, the investigators will explore specific chemotherapy toxicities associated with reduced relative dose intensity of a prescribed regimen.

Condition or disease
Breast Cancer

Detailed Description:

Although cancer is a disease associated with aging, there is no standard tool in oncology practice that incorporates clinical and biological factors to identify older adults with cancer who may be more vulnerable to the toxicity of chemotherapy. It is generally recognized that chronological age tells relatively little about an older adult's physiological age. Oncologists allude to this when they describe an older adult as: "a 'young' 80-year-old" or "an 'old' 80-year-old," implying factors other than age contribute to the health status of an older adult. Geriatricians address this by routinely performing a "geriatric assessment," which measures independent clinical predictors of morbidity and mortality in older adults. In addition, several potential biomarkers of aging have been described that are associated with functional decline and mortality among older adults. This study will identify whether novel biomarkers of aging can predict risk of chemotherapy toxicity. The current proposal will fill this knowledge gap by melding the principles of geriatrics with those of oncology to create a tool to assess the clinical and biological risk factors for chemotherapy toxicity in older adults.

Furthermore, this study will determine the association between chemotherapy toxicity and dose reductions and/or delays that decrease chemotherapy dose intensity. Maintenance of chemotherapy dose intensity is necessary to maintain chemotherapy efficacy. Older adults are at risk for chemotherapy toxicity and if this toxicity results in decreased dose intensity, the benefits of chemotherapy will be compromised. This study will identify the association between clinical and biological predictors of grade 2-5 toxicity and relative dose intensity. Furthermore, this study will identify the specific dose-limiting toxicities. These data will provide evidence-based criteria to identify those patients whose projected risk of toxicity would limit dose intensity and compromise the efficacy of standard treatment. These data could serve as the basis for "vulnerable elderly trials" which would study an alternate therapy regimen in patients who are predicted to have a significant risk of toxicity (and compromised efficacy) with the standard regimen.

This proposal unites the fields of geriatrics and oncology, incorporating geriatric correlates of vulnerability and studying their impact in an aging oncology population. These data will be used to develop a predictive equation for the risk of chemotherapy toxicity that can be utilized in daily oncology practice. These data will facilitate decision-making regarding the risks and benefits of adjuvant chemotherapy in older adults with breast cancer and ultimately serve as a foundation on which to identify older adults at risk for chemotherapy toxicity in order to guide interventions to decrease this risk.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
Actual Study Start Date : September 9, 2011
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
All patients 65 years old with Stage I to III breast cancer who are beginning adjuvant or neo-adjuvant chemotherapy.



Primary Outcome Measures :
  1. Develop a predictive model of clinical and biological predictors for grade 2-5 toxicity to adjuvant and neoadjuvant chemotherapy. [ Time Frame: 6 months after completion of chemotherapy ]
  2. Understand the association between clinical and biological factors and reduced relative dose intensity (RDI) of the prescribed chemotherapy regimen. [ Time Frame: 6 months after completion of chemotherapy ]
  3. Identify the specific chemotherapy toxicities associated with reduced relative dose intensity of the prescribed chemotherapy regimen. [ Time Frame: 6 months after completion of chemotherapy ]
  4. Understand the association between the receipt of adjuvant chemotherapy and change in functional status from pre-chemotherapy to end of chemotherapy. [ Time Frame: 6 months after completion of chemotherapy ]

Secondary Outcome Measures :
  1. Assess potential biomarkers for physiologic age, including interleukin-6, C-reactive protein, D-dimer, and p16 expression. [ Time Frame: 6 months after completion of chemotherapy ]

Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient clinic practices (City of Hope, Memorial Sloan-Kettering Cancer Center, Yale University School of Medicine, University of Rochester, University of North Carolina, Wake Forest University, and Case Western Reserve University)
Criteria

Patients with Breast Cancer:

Inclusion Criteria:

  • Patients with stages I-III breast cancer receiving adjuvant or neoadjuvant chemotherapy
  • Able to understand English
  • Able to provide informed consent
  • Patients age ≥65 and of any performance status are eligible

Exclusion Criteria:

  • Patients with metastatic disease

Breast Cancer Controls:

Inclusion Criteria:

  • Patients with stages I-III breast cancer
  • Patient will not receive adjuvant or neoadjuvant chemotherapy
  • Patients age ≥65 and of any performance status are eligible
  • Able to understand English
  • Able to provide informed consent

Exclusion Criteria:

  • Patients with metastatic disease
  • Receipt of chemotherapy

Healthy Controls:

Inclusion Criteria:

  • Patients age ≥65 and of any performance status are eligible
  • No history of cancer (excluding non-melanoma skin cancer)
  • Able to understand English
  • Able to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472094


Locations
Show Show 17 study locations
Sponsors and Collaborators
City of Hope Medical Center
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Mina Sedrak, MD City of Hope Medical Center
Additional Information:
Publications:
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01472094    
Other Study ID Numbers: 11127
1R01AG037037-01 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021