Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Specimen Collection, Stool Specimen Collection, Quality of Life (QOL) Questionnaires.
- Who it may be relevant to
- Registry conditions: Cancer, Thoracic Cancer, Gynecologic Cancer, Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Evaluation of Changes in the Relationships Between Fatigue and Molecular Mechanisms in Cancer Patients Receiving Curative-Intent Combined Chemotherapy and Radiation Therapy (CCRT)
Overview
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.
Detailed 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-CCRT using demographic, clinical, and molecular characteristics collected prior the initiation of CCRT.
Secondary Objectives For the commonly co-occurring symptom of chemotherapy-induced peripheral neuropathy (CIPN):
Secondary Aim 5. Evaluate for associations between phenotypic characteristics and initial levels and the trajectories of CIPN.
Secondary Aim 6. Evaluate for associations between changes in CIPN severity and changes in gene expression levels prior to the initiation and at the end of CCRT.
Secondary Aim 7. Evaluate for associations between changes in CIPN severity and changes in circulating free cytokine levels prior to the initiation and at the end of CCRT.
Secondary Aim 8. Develop and assess predictive models for CIPN severity midway, at the end of, and at least six months post-CCRT using demographic, clinical, and molecular characteristics collected prior the initiation of CCRT.
Exploratory Aim 1 - Evaluate the feasibility of the protocol for the collection of stool samples.
Exploratory Aim 2 - Evaluate the feasibility of processing and storing stool samples.
Exploratory Aim 3 - Evaluate the feasibility of processing and storing performing blood samples and performing Cytometry by time of flight (CyTOF) assays.
Interventions
- Procedure Blood Specimen Collection
Blood samples will be obtained throughout the course of the study - Other Stool Specimen Collection
Stool samples will be obtained throughout the course of the study - Other Quality of Life (QOL) Questionnaires
Surveys will be given throughout the course of the study.
Primary outcome measures
- Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time [Time frame: Up to 34 weeks]
- Measure associations between changes in CRF and changes in cytokine levels over time [Time frame: Up to 34 weeks]
- Measure associations between changes in CRF and changes in gene expression over time [Time frame: Up to 34 weeks]
- Evaluate the predictive utility of gene expression and cytokine data [Time frame: Up to 34 weeks]
Secondary outcome measures (5)
- Evaluate for associations between changes in chemotherapy-induced peripheral neuropathy (CIPN) and changes in gene expression [Time frame: Up to 34 weeks]
- Evaluate for associations between changes in CIPN and changes in cytokine levels [Time frame: Up to 34 weeks]
- Evaluate the predictive utility of gene expression and severity of CIPN [Time frame: Up to 34 weeks]
- Evaluate the predictive utility of cytokine levels and severity of CIPN [Time frame: Up to 34 weeks]
- Evaluate the predictive model of severity of CIPN [Time frame: Up to 34 weeks]
Eligibility criteria
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 for clinical information.
- Able to read, write and understand English or Spanish.
Exclusion criteria
- Contraindication to phlebotomy for removal of approximately 50 mL of peripheral blood within 6 week period (Institutional Review Board (IRB) limit).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06633224 · 239814 · R37CA233774 · NCI-2024-08455