NCT06633224

Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT

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: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Thoracic Cancer
• Gynecologic Cancer
• Head and Neck Cancer
• Gastrointestinal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-27
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2024-10-09
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States