Evaluating fatigue and molecular mechanisms in cancer patients undergoing combined chemotherapy and radiation therapy
An Evaluation of Changes in the Relationships Between Fatigue and Molecular Mechanisms in Cancer Patients Receiving Curative-Intent Combined Chemotherapy and Radiation Therapy (CCRT)
University of California, San Francisco · NCT06633224
This study is testing how fatigue affects cancer patients getting both chemotherapy and radiation therapy, and whether certain genes and molecules are linked to how tired they feel during treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06633224 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate cancer-related fatigue (CRF) in patients receiving standard combined chemotherapy and radiation therapy (CCRT). It will assess the relationship between molecular characteristics and CRF severity at various stages of treatment. The study will also explore the association between changes in CRF and gene expression levels, as well as circulating cytokine levels. Additionally, predictive models for CRF and chemotherapy-induced peripheral neuropathy (CIPN) severity will be developed using demographic and clinical data.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are starting CCRT and have not received prior cancer treatments in the past year.
Not a fit: Patients who have received prior systemic therapies or radiation therapy within the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for cancer-related fatigue, improving the quality of life for cancer patients.
How similar studies have performed: While studies on cancer-related fatigue exist, this specific approach focusing on molecular mechanisms and predictive modeling is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Sue Yom, MD — University of California, San Francisco
- Study coordinator: Jamese Johnson
- Email: Jamese.Johnson@ucsf.edu
- Phone: (415) 530-9805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Thoracic Cancer, Gynecologic Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Basic Science Research