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Observational Study on Fatigue in Cancer Patients Receiving Chemotherapy and Radiation

This observational study is looking at cancer-related fatigue (CRF), a common problem for cancer patients. Researchers want to understand how CRF changes over time in patients with thoracic, gynecologic, head and neck, or gastrointestinal cancers who are receiving standard chemotherapy and radiation therapy (CCRT). They will collect blood and stool samples, and you will complete surveys about your quality of life. The goal is to find connections between changes in your fatigue and changes in your genes and cytokine levels (proteins that help cells communicate). This information will help develop ways to predict how severe fatigue might become. You may be able to join if you are over 18, have not had recent cancer treatment (except surgery or initial chemotherapy), and are receiving at least 15 sessions of radiation.

Study design
This is an observational study, meaning researchers will watch and collect information without giving new treatments. It plans to include 125 participants.
What's involved
You would provide blood and stool samples throughout the study. You would also complete quality of life questionnaires throughout the study, up to 34 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes over time, with primary endpoints measured up to 34 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06633224

Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT

Recruiting
Not specifiedAges 18+Observational
University of California, San Francisco
~125 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:Blood Specimen CollectionStool Specimen CollectionQuality of Life (QOL) Questionnaires

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time
Measured over Up to 34 weeks
+3 more outcomes measured

Conditions

Cancer
Thoracic Cancer
Gynecologic Cancer
Head and Neck Cancer
Gastrointestinal Cancer

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Malignant Digestive System NeoplasmMalignant Female Reproductive System NeoplasmMalignant Head and Neck NeoplasmMalignant NeoplasmThoracic Neoplasm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sue Yom, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Jamese Johnson
[email protected]
(415) 530-9805
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

  • Measure associations between changes in CRF and changes in cytokine levels over timeUp 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%.

  • Measure associations between changes in CRF and changes in gene expression over timeUp 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%.

  • Evaluate the predictive utility of gene expression and cytokine dataUp 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.