Clinical trial NCT03924557: Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
Official title: A Randomized Pragmatic Trial of Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chemotherapy
Supportive Care
Genotyping
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled, parallel arm study.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This is a single center, pilot randomized pragmatic clinical trial (PCT) of 500 cancer patients who are undergoing chemotherapy for newly diagnosed or recurrent cancers. Patients will be randomized to genotyping intervention vs delayed genotyping intervention supportive care. Supportive care regimens may include therapies for antiemesis (ondansetron), pain management (opiates), GI protection (PPIs), antidepressants (select SSRIs), and antifungal prophylaxis (voriconazole), and warfarin depending on their chemotherapy regimen.

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. For those randomized to the delayed genotype intervention group, supportive care will be prescribed based on usual clinical practice. Both groups will be followed for 3 months and undergo assessments with the MDASI questionnaire four times (pre-chemotherapy, and 2 weeks, 4 weeks and 12 weeks post initiation of chemotherapy.

Records for patients receiving outpatient care at the UF Health Cancer Center clinic at the Medical Plaza will be screened based on inclusion / exclusion criteria for participation in this study. Those that meet criteria will be offered participation. Participation is expected to last approximately 12 weeks and the study will be open for 30-36 months.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in patient MDASI scoring
timeFrame: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
Secondary outcomes:
measure: Change in patient medication use
timeFrame: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: UF Health Cancer Center
state: Florida
Study officials:
affiliation: University of Florida
name: Rhonda Cooper-DeHoff, Pharm D, MS
role: PRINCIPAL_INVESTIGATOR
References: