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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients

Clinicaltrials.gov identifier NCT03924557

Recruitment Status Active, not recruiting

First Posted April 23, 2019

Last update posted May 11, 2021

Study Description

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.

  • Condition or Disease:Chemotherapy
    Supportive Care
    Genotyping
  • Intervention/Treatment: Diagnostic Test: Genotype-guided Supportive Care
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 148 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: This is a randomized, controlled, parallel arm study.
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: A Randomized Pragmatic Trial of Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: June 2023
Arms and interventions
Arm Intervention/treatment
Active Comparator: Genotyping Intervention Supportive Care
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
In this arm, supportive care will be administered based on the results of the genotype test.
Outcome Measures
  • Primary Outcome Measures: 1. Change in patient MDASI scoring [ Time Frame: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy. ]
    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.
  • Secondary Outcome Measures: 1. Change in patient medication use [ Time Frame: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy. ]
    Concomitant Medication Review will be collected from patients or from their electronic medical record to evaluate differences in medication use (drug and dose) based on randomized group.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts
Locations

United States, Florida
UF Health at the University of Florida
Gainesville

United States, Florida
UF Health Cancer Center
Gainesville

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Rhonda Cooper-DeHoff, Pharm D, MS University of Florida

More Information
  • Responsible Party: University of Florida
  • ClinicalTrials.gov Identifier: NCT03924557 History of Changes
  • Other Study ID Numbers: UF-ETG-002, OCR20388, IRB201901177
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: May 11, 2021
  • Last Verified: May 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No