Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Under 65 years
- description
- Breast cancer patients receiving adjuvant chemotherapy. Those under 65 years of age will be prospectively evaluated for outcome.
- label
- Over 65 years
- description
- Breast cancer patients receiving adjuvant chemotherapy. Those over 65 years of age will be prospectively evaluated for outcome.
Primary outcomes (1)
- 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.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Assess potential biomarkers for physiologic age, including Advanced Glycation Endproducts (AGEs) and markers for oxidative stress and inflammation (e.g. 8-OHdG).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYuan 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