Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Sue Yom, MD (ucsf)
Headshot of Sue Yom
Sue Yom

Description

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.

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)

Details

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.

Keywords

Cancer, Thoracic Cancer, Gynecologic Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Basic Science Research, Gastrointestinal Neoplasms, Blood Specimen Collection, Stool Specimen Collection

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at University of California Health

  • Sue Yom, MD (ucsf)
    I am a radiation oncologist who specializes in the treatment of head and neck, lung, and skin cancers. I serve on national guidelines committees outlining the best practices for these cancers. I design clinical trials to improve treatment of these cancers. I give lectures and design courses to help others learn more about how to best treat these cancers.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06633224
Study Type
Observational
Participants
Expecting 125 study participants
Last Updated