Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT

NCT ID: NCT06633224

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-27
• Study Completion Date: 2027-09-01

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.

Conditions

Cancer; Thoracic Cancer; Gynecologic Cancer; Head and Neck Cancer; Gastrointestinal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer Patients

Participants will have blood and stool samples collected within 5 days of any pre or post treatment timepoint prior to, during, at completion of therapy and up to 34 weeks following non-investigational, standard of care, CCRT. Participants will also be given quality of life questionnaires to complete throughout the course of the study.

Blood Specimen Collection

Intervention Type: PROCEDURE

Blood samples will be obtained throughout the course of the study

Stool Specimen Collection

Intervention Type: OTHER

Stool samples will be obtained throughout the course of the study

Quality of Life (QOL) Questionnaires

Intervention Type: OTHER

Surveys will be given throughout the course of the study.

Interventions

Blood Specimen Collection

Blood samples will be obtained throughout the course of the study

Intervention Type: PROCEDURE

Stool Specimen Collection

Stool samples will be obtained throughout the course of the study

Intervention Type: OTHER

Quality of Life (QOL) Questionnaires

Surveys will be given throughout the course of the study.

Intervention Type: OTHER

Other Intervention Names

Blood Specimen; Stool Specimen; Quality of Life Surveys

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sue Yom, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jamese Johnson

Role: CONTACT

Jamese.Johnson@ucsf.edu

(415) 530-9805

Facility Contacts

Jamese Johnson

Role: primary

Jamese.Johnson@ucsf.edu

415-530-9805

Role: backup

cancertrials@ucsf.edu

877-827-3222

Other Identifiers

R37CA233774

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2024-08455

Identifier Type: REGISTRY

Identifier Source: secondary_id

239814

Identifier Type: -

Identifier Source: org_study_id