Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Specimen Collection | Procedure | — | UNRESOLVED |
| Quality of Life (QOL) Questionnaires | Other | — | UNRESOLVED |
| Stool Specimen Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer Patients
- description
- 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.
- interventionNames
- Procedure: Blood Specimen Collection
- Other: Stool Specimen Collection
- Other: Quality of Life (QOL) Questionnaires
Primary outcomes (4)
- measure
- Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time
- timeFrame
- Up to 34 weeks
- description
- Association between phenotypic characteristics and initial levels and trajectories of CRF severity will be assessed using a hierarchical linear model (HLM) approach.
- measure
- Measure associations between changes in CRF and changes in cytokine levels over time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available