ChemotherapyNCT03924557
Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
A study testing Genotype-guided Supportive Care in people with Chemotherapy and Supportive Care, run by University of Florida at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy, Supportive Care, Genotyping
- What is being tested?
- Genotype-guided Supportive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2019to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health at the University of Florida
Gainesville, Florida, 32610
UF Health Cancer Center
Gainesville, Florida, 32610
About this study
Official title: A Randomized Pragmatic Trial of Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
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.
Read the 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.
- Conditions
- Chemotherapy, Supportive Care, Genotyping
- Being tested
- Genotype-guided Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotype-guided Supportive CareDiagnostic test
In this arm, supportive care will be administered based on the results of the genotype test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
Secondary outcomes (1)
Change in patient medication use
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.
Measured: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start9 Jul 2019
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Why it stopped: funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChemotherapyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, parallel arm study.
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rhonda Cooper-DeHoff, Pharm D, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924557
- Sponsor's protocol ID
- UF-ETG-002
- Other IDs
- OCR20388, IRB201901177
- Status last verified
- Jan 2023
- First submitted
- 19 Apr 2019
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39046302
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pragmatic Trial of Genotype-guided Supportive Care in Symptom Treatment of Cancer Patients
- ClinicalTrials.gov ID
- NCT03924557
- Acronym / sponsor ID
- UF-ETG-002
- Conditions
- Chemotherapy, Supportive Care, Genotyping
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding issues
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, parallel arm study.
| Arm | Type | Receives |
|---|---|---|
| Genotyping Intervention Supportive Care | Active comparator | Diagnostic Test: Genotype-guided Supportive CareFor 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genotype-guided Supportive CareIn this arm, supportive care will be administered based on the results of the genotype test. | Diagnostic test | Genotyping Intervention Supportive Care |
Primary outcome
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.
1 secondary outcome
Change in patient medication use
Time frame: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.
Results and safety
The study was stopped early (reason given: funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Derived from this study: PubMed 39046302Cicali 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhonda Cooper-DeHoff, Pharm D, MS principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genotype-guided Supportive Care in people with Chemotherapy and Supportive Care, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: funding issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient MDASI scoring (time frame: At pre-chemotherapy (baseline), 2 weeks, 4 weeks, and 12 weeks post initiation of chemotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.