Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT

NCT06633224 | Recruiting

• 3 other identifiers: 239814R37CA233774NCI-2024-08455
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Basic Science Research

Outcome Measures

Primary Outcomes (4)

• Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time

  Association between phenotypic characteristics and initial levels and trajectories of CRF severity will be assessed using a hierarchical linear model (HLM) approach.

  Up to 34 weeks

• Measure associations between changes in CRF and changes in cytokine levels over time

  Association between changes in CRF severity and biomarker levels prior to the initiation and at the end of CCRT. Linear regression will be used to evaluate for associations between fatigue changes and biomarker levels at baseline controlling for covariates identified in the initial primary outcome. Adjustments for multiple comparisons will be conducted using the Benjamini-Hochberg (BH) procedure at a false discovery rate (FDR) of 10%.

  Up to 34 weeks

• Measure associations between changes in CRF and changes in gene expression over time

  Association between changes in CRF severity and gene expression prior to the initiation and at the end of CCRT. Linear regression will be used to evaluate for associations between fatigue changes and biomarker levels at baseline controlling for covariates identified in the initial primary outcome. Adjustments for multiple comparisons will be conducted using the Benjamini-Hochberg (BH) procedure at a false discovery rate (FDR) of 10%.

  Up to 34 weeks

• Evaluate the predictive utility of gene expression and cytokine data

  A validated prediction model of CRF severity will be generated using machine learning (ML) methods to minimize the error between predicted and observed levels of fatigue midway through CCRT, at the completion of CCRT, and at least six months following the completion of CCRT. Evaluation of common ML algorithms for prediction accuracy and evaluation of model performance as compared to simple linear regression. Separate training and testing sets will be created, cross-validated, and repeated and impact of each variable will be determined.

  Up to 34 weeks

Secondary Outcomes (5)

• Evaluate for associations between changes in chemotherapy-induced peripheral neuropathy (CIPN) and changes in gene expression

  Up to 34 weeks

• Evaluate for associations between changes in CIPN and changes in cytokine levels

  Up to 34 weeks

• Evaluate the predictive utility of gene expression and severity of CIPN

  Up to 34 weeks

• Evaluate the predictive utility of cytokine levels and severity of CIPN

  Up to 34 weeks

• Evaluate the predictive model of severity of CIPN

  Up to 34 weeks

Study Arms (1)

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.

Procedure: Blood Specimen Collection; Other: Stool Specimen Collection; Other: Quality of Life (QOL) Questionnaires

Interventions

Blood Specimen Collection PROCEDURE

Blood samples will be obtained throughout the course of the study

Also known as: Blood Specimen

Cancer Patients

Stool Specimen Collection OTHER

Stool samples will be obtained throughout the course of the study

Also known as: Stool Specimen

Cancer Patients

Quality of Life (QOL) Questionnaires OTHER

Surveys will be given throughout the course of the study.

Also known as: Quality of Life Surveys

Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cancer patients willing to travel to San Francisco, receiving CCRT at University of California, San Francisco (UCSF) for cancers of the head and neck, gynecological, gastrointestinal, or thoracic sites.

You may qualify if:

• 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.

You may not qualify if:

• Contraindication to phlebotomy for removal of approximately 50 mL of peripheral blood within 6 week period (Institutional Review Board (IRB) limit).

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 16 mL of blood and a stool sample will be obtained at each visit.

MeSH Terms

Conditions

Neoplasms; Head and Neck Neoplasms; Gastrointestinal Neoplasms

Interventions

Blood Specimen Collection; Quality of Life; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Sue Yom, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamese Johnson

CONTACT

(415) 530-9805; Jamese.Johnson@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: December 27, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)