Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients

NCT03924557 | Terminated DMC

• 3 other identifiers: UF-ETG-002OCR20388IRB201901177
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

Brief Summary

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

Chemotherapy; Supportive Care; Genotyping

Outcome Measures

Primary Outcomes (1)

• Change in patient MDASI scoring

  The M. D. Anderson Symptom Inventory (MDASI) is a multisymptom patient-reported outcome measure. Participants are asked to recall symptom interference and severity during the past 24 hours and rate the symptom using a numeric rating scale, 0-10. For the symptom interference questions, 10 means interfered completely and 0 is did not interfere. For the symptom severity questions, 10 means as bad as you can imagine and 0 is not present. The MDASI questionnaire will evaluate symptom distress and core symptoms of patients at four separate time points.

  At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.

Secondary Outcomes (1)

• Change in patient medication use

  At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.

Study Arms (2)

Genotyping Intervention Supportive Care

ACTIVE COMPARATOR

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.

Diagnostic Test: Genotype-guided Supportive Care

Delayed Genotyping Intervention Supportive Care

NO INTERVENTION

For those randomized to the delayed genotype intervention group, supportive care will be prescribed based on usual clinical practice.

Interventions

Genotype-guided Supportive Care DIAGNOSTIC_TEST

In this arm, supportive care will be administered based on the results of the genotype test.

Genotyping Intervention Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

UF Health Cancer Center

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Cicali 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 DERIVED

Study Officials

• Rhonda Cooper-DeHoff, Pharm D, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, parallel arm study.

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 23, 2019
• Study Start: July 9, 2019
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)