Clinical trial NCT06633224: Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Thoracic Cancer
Gynecologic Cancer
Head and Neck Cancer
Gastrointestinal Cancer
Keywords: Basic Science Research
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-09
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Participants have not received any prior treatment (i.e., cancer systemic therapies or radiation therapy) in the past year except surgery.
* 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).

Primary outcomes:
measure: Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time
timeFrame: Up to 34 weeks
measure: Measure associations between changes in CRF and changes in cytokine levels over time
timeFrame: Up to 34 weeks
measure: Measure associations between changes in CRF and changes in gene expression over time
timeFrame: Up to 34 weeks
measure: Evaluate the predictive utility of gene expression and cytokine data
timeFrame: Up to 34 weeks
Secondary outcomes:
measure: Evaluate for associations between changes in chemotherapy-induced peripheral neuropathy (CIPN) and changes in gene expression
timeFrame: Up to 34 weeks
measure: Evaluate for associations between changes in CIPN and changes in cytokine levels
timeFrame: Up to 34 weeks
measure: Evaluate the predictive utility of gene expression and severity of CIPN
timeFrame: Up to 34 weeks
measure: Evaluate the predictive utility of cytokine levels and severity of CIPN
timeFrame: Up to 34 weeks
measure: Evaluate the predictive model of severity of CIPN
timeFrame: Up to 34 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sue Yom, MD
role: PRINCIPAL_INVESTIGATOR
References: