Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633224
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None