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

NCT01030250 | Active Not Recruiting DMC

• 2 other identifiers: 08242R03AG050931
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Assess potential biomarkers for physiologic age, including Advanced Glycation Endproducts (AGEs) and markers for oxidative stress and inflammation (e.g. 8-OHdG).

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

Related Publications (1)

• Yuan Y, Vora N, Sun CL, Li D, Soto-Perez-de-Celis E, Mortimer J, Luu TH, Somlo G, Waisman J, Smith D, Chao J, Katheria V, Synold T, Tran V, Mi S, Levi A, Arsenyan A, Choi J, Zavala L, Yost S, Hurria A. Association of pre-chemotherapy peripheral blood pro-inflammatory and coagulation factors with reduced relative dose intensity in women with breast cancer. Breast Cancer Res. 2017 Aug 29;19(1):101. doi: 10.1186/s13058-017-0895-5.

  PMID: 28851415 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Urine to be collected prior to commencement of chemotherapy

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Arti Hurria, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 11, 2009
• Study Start: June 11, 2009
• Primary Completion: August 14, 2019
• Study Completion (Estimated): February 5, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)