RecruitingNCT06633224

Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT

An Evaluation of Changes in the Relationships Between Fatigue and Molecular Mechanisms in Cancer Patients Receiving Curative-Intent Combined Chemotherapy and Radiation Therapy (CCRT)


Sponsor

University of California, San Francisco

Enrollment

125 participants

Start Date

Dec 27, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria1

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

Interventions

PROCEDUREBlood Specimen Collection

Blood samples will be obtained throughout the course of the study

OTHERStool Specimen Collection

Stool samples will be obtained throughout the course of the study

OTHERQuality of Life (QOL) Questionnaires

Surveys will be given throughout the course of the study.


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06633224


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