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NCT Number: NCT06633224

Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT

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.

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Key information

Conditions

Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Gynecologic Cancer Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Thoracic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Jamese Johnson

CONTACT

[email protected]

415-530-9805

Kord M Kober, PhD

PRINCIPAL_INVESTIGATOR

Sue Yom, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

877-827-3222

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood specimen collection

Procedure

Blood samples will be obtained throughout the course of the study

Other names: Blood Specimen

Stool Specimen Collection

Other

Stool samples will be obtained throughout the course of the study

Other names: Stool Specimen

Quality of Life (QOL) Questionnaires

Other

Surveys will be given throughout the course of the study.

Other names: Quality of Life Surveys

Primary outcomes

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

    Time frame: Up to 34 weeks

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

  2. Measure associations between changes in CRF and changes in cytokine levels over time

    Time frame: Up to 34 weeks

    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%.

  3. Measure associations between changes in CRF and changes in gene expression over time

    Time frame: Up to 34 weeks

    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%.

  4. Evaluate the predictive utility of gene expression and cytokine data

    Time frame: Up to 34 weeks

    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.

Secondary outcomes

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

    Time frame: Up to 34 weeks

    The association between phenotypic characteristics and initial levels and trajectories of CIPN severity will be evaluated using a hierarchical linear model (HLM) approach.

  2. Evaluate for associations between changes in CIPN and changes in cytokine levels

    Time frame: Up to 34 weeks

    The association between phenotypic characteristics and initial levels and trajectories of CIPN severity will be evaluated using a hierarchical linear model (HLM) approach.

  3. Evaluate the predictive utility of gene expression and severity of CIPN

    Time frame: Up to 34 weeks

    The association between changes in CIPN severity and gene expression prior to the initiation and at the end of CCRT. Linear regression will be used to evaluate for associations between CIPN changes and gene expression at baseline controlling for covariates identified in previous objectives/endpoints. Adjustments for multiple comparisons will be performed using the Benjamini-Hochberg (BH) procedure at a false discovery rate (FDR) of 10%.

  4. Evaluate the predictive utility of cytokine levels and severity of CIPN

    Time frame: Up to 34 weeks

    The association between changes in CIPN severity and cytokine levels prior to the initiation and at the end of CCRT. Linear regression will be used to evaluate for associations between CIPN changes and cytokine levels at baseline controlling for covariates identified in previous objectives/endpoints. Adjustments for multiple comparisons will be performed using the Benjamini-Hochberg (BH) procedure at a false discovery rate (FDR) of 10%.

  5. Evaluate the predictive model of severity of CIPN

    Time frame: Up to 34 weeks

    The predictive utility will be assessed through a validated prediction model of CIPN severity using machine learning (ML) methods to minimize the error between predicted and observed levels of CIPN midway through CCRT, at the completion of CCRT, and at least six months following the completion of CCRT. We will evaluate common ML algorithms for prediction accuracy and evaluate their performance as compared to simple linear regression

Study contacts

Contact information is provided by the study sponsor or research team.

Jamese Johnson

CONTACT

[email protected]

(415) 530-9805

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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