An Evaluation of Changes in the Relationships Between Fatigue and Molecular Mechanisms in Cancer Patients Receiving Curative-Intent Combined Chemotherapy and Radiation Therapy (CCRT)
University of California, San Francisco
Summary
Cancer-related fatigue (CRF) is a significant problem for cancer patients. This prospective, basic science, observational study will evaluate for changes in CRF associated with molecular characteristics prior to, during, and at the completion of non-investigational, standard-of-care, combined chemotherapy and radiation therapy (CCRT) and to develop and assess predictive models for CRF severity.
Description
Primary Objective For mean, morning and evening CRF: Aim 1. Evaluate for associations between phenotypic characteristics and initial levels and the trajectories of CRF. Aim 2. Evaluate for associations between changes in CRF severity and changes in gene expression levels prior to the initiation and at the end of CCRT. Aim 3. Evaluate for associations between changes in CRF severity and changes in circulating free cytokine levels prior to the initiation and at the end of CCRT. Aim 4. Develop and assess predictive models for CRF severity midway, at the end of, and at least six months post-CC…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants have not received any prior treatment (i.e., cancer systemic therapies or radiation therapy) in the month except surgery or inductive Chemotherapy (CTX). * Participants receiving \>= 15 fractions. * Participants is male or female and is \>18 years of age on the day of signing the informed consent. * Ability to understand a written informed consent document. * Able and willing to complete all of the study questionnaires and provide blood and stool samples prior to, midway, and following the completion of treatment. * Willing to have medical records reviewed f…
Interventions
- ProcedureBlood Specimen Collection
Blood samples will be obtained throughout the course of the study
- OtherStool Specimen Collection
Stool samples will be obtained throughout the course of the study
- OtherQuality of Life (QOL) Questionnaires
Surveys will be given throughout the course of the study.
Location
- University of California, San FranciscoSan Francisco, California