CancerNCT06633224
Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT
An observational study of Cancer and Thoracic Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Thoracic Cancer, Gynecologic Cancer
- What is being tested?
- Blood Specimen Collection, Stool Specimen Collection and Quality of Life (QOL) Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2024to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Contraindication to phlebotomy for removal of approximately 50 mL of peripheral blood within 6 week period (Institutional Review Board (IRB) limit).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Imani Dunn, 877-827-3222, Imani.Dunn@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official 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)
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.
Read the 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
- Being tested
- Blood Specimen Collection, Stool Specimen Collection, Quality of Life (QOL) Questionnaires
- Keywords
- Basic Science Research
- Medical subject headings
- Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Specimen CollectionProcedure or surgery
Also called Blood Specimen
Blood samples will be obtained throughout the course of the study
Stool Specimen CollectionOther
Also called Stool Specimen
Stool samples will be obtained throughout the course of the study
Quality of Life (QOL) QuestionnairesOther
Also called Quality of Life Surveys
Surveys will be given throughout the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood Specimen Collection; Other: Stool Specimen Collection; Other: Quality of Life (QOL) Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: Up to 34 weeks
Secondary outcomes (5)
Evaluate for associations between changes in chemotherapy-induced peripheral neuropathy (CIPN) and changes in gene expression
The association between phenotypic characteristics and initial levels and trajectories of CIPN severity will be evaluated using a hierarchical linear model (HLM) approach.
Measured: Up to 34 weeks
Evaluate for associations between changes in CIPN and changes in cytokine levels
The association between phenotypic characteristics and initial levels and trajectories of CIPN severity will be evaluated using a hierarchical linear model (HLM) approach.
Measured: Up to 34 weeks
Evaluate the predictive utility of gene expression and severity of CIPN
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%.
Measured: Up to 34 weeks
Evaluate the predictive utility of cytokine levels and severity of CIPN
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%.
Measured: Up to 34 weeks
Evaluate the predictive model of severity of CIPN
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
Measured: Up to 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start27 Dec 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sue Yom, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633224
- Sponsor's protocol ID
- 239814
- Other IDs
- R37CA233774, NCI-2024-08455
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06633224
- Acronym / sponsor ID
- 239814
- Conditions
- Cancer, Thoracic Cancer, Gynecologic Cancer, Head and Neck Cancer, Gastrointestinal Cancer
- Keywords
- Basic Science Research
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients | – | Procedure: Blood Specimen Collection, Other: Stool Specimen Collection, Other: Quality of Life (QOL) QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Contraindication to phlebotomy for removal of approximately 50 mL of peripheral blood within 6 week period (Institutional Review Board (IRB) limit).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Specimen CollectionAlso: Blood SpecimenBlood samples will be obtained throughout the course of the study | Procedure or surgery | Cancer Patients |
| Stool Specimen CollectionAlso: Stool SpecimenStool samples will be obtained throughout the course of the study | Other | Cancer Patients |
| Quality of Life (QOL) QuestionnairesAlso: Quality of Life SurveysSurveys will be given throughout the course of the study. | Other | Cancer Patients |
Primary outcome
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.
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%.
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%.
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.
5 secondary outcomes
Evaluate for associations between changes in chemotherapy-induced peripheral neuropathy (CIPN) and changes in gene expression
Time frame: Up to 34 weeks
Evaluate for associations between changes in CIPN and changes in cytokine levels
Time frame: Up to 34 weeks
Evaluate the predictive utility of gene expression and severity of CIPN
Time frame: Up to 34 weeks
Evaluate the predictive utility of cytokine levels and severity of CIPN
Time frame: Up to 34 weeks
Evaluate the predictive model of severity of CIPN
Time frame: Up to 34 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue Yom, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Thoracic Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imani Dunn (877-827-3222, Imani.Dunn@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time (time frame: Up to 34 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.