Clinical trial · Interventional
Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
A Randomized Pragmatic Trial of Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding issues
Summary
Brief summary (as posted)
Cancer patients often require administration of multiple supportive care pharmacotherapies while receiving chemotherapy regardless the type of cancer. Supportive care therapies are commonly prescribed to nearly all cancer patients and could include antiemetics (ondansetron), pain management (opiates), GI protection (PPIs), antidepressants (select SSRIs), anticoagulation (warfarin) and antifungal prophylaxis (voriconazole). These are all are associated with known pharmacogenetic interactions, which in some cases render the drugs ineffective or toxic. This could result in negative impacts on quality of life in patients who are already undergoing complicated and costly anticancer regimens. Pharmacogenetic-guided therapy based on an individual patient's genetic profile could potentially target symptoms for which an individual is uniquely susceptible, guiding use of medications that are most likely to be effective, thereby reducing unnecessary physical complications and financial strain. It is hypothesized that patients in the genotype intervention arm will report lower scores for overall symptom distress as compared to patients in the delayed genotype intervention arm following initiation of chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Genotyping | — | UNRESOLVED | — |
| Supportive Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genotype-guided Supportive Care | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Genotyping Intervention Supportive Care
- description
- For those randomized to the genotype intervention group, genotype results will be returned in the EHR pre-emptively and supportive care will be prescribed based on genotype results.
- interventionNames
- Diagnostic Test: Genotype-guided Supportive Care
- type
- NO_INTERVENTION
- label
- Delayed Genotyping Intervention Supportive Care
- description
- For those randomized to the delayed genotype intervention group, supportive care will be prescribed based on usual clinical practice.
Primary outcomes (1)
- measure
- Change in patient MDASI scoring
- timeFrame
- At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have a clinical diagnosis of solid tumor cancer and be seeking treatment and supportive care at the UF Health Cancer Center (Medical Plaza) * Patients must plan to receive chemotherapy known to be associated with the need for supportive care within 30 days of enrollment * Life expectancy must be greater than 6 months * Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Written informed consent obtained from the patient * The ability for the patient to comply with all the study-related procedures. Exclusion Criteria: * Patients unwilling or unable to provide voluntary informed consent * Patients who are unwilling or unable to comply with protocol requirement and/or follow-up procedures * Patients planned to undergo cancer therapy other than chemotherapy (i.e., radiation, surgery or hormonal treatment alone) * Prisoners or patients who are involuntarily incarcerated. Patients who are compulsorily detained for treatment of either a psychiatric or physical illness.
References
Publications (1)
- DERIVEDCicali EJ, Eddy E, Gong Y, Elchynski AL, Pena Del Aguila K, Basha T, Daily KC, Dickson L, Fischer S, Hastings-Monari E, Jones D Jr, Ramnaraign BH, DeRemer DL, George TJ, Cooper-DeHoff RM. Implementation of a pharmacogenetic panel-based test for pharmacotherapy-based supportive care in an adult oncology clinic. Clin Transl Sci. 2024 Jul;17(7):e13890. doi: 10.1111/cts.13890. PMID 39046302