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Red Blood Cell Transfusion Thresholds for Improved Quality of Life for Patients Undergoing a Pancreatectomy for Pancreatic Cancer

Primary Purpose

Resectable Pancreatic Carcinoma

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)
Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)
Computed Tomography
X-Ray Imaging
Biospecimen Collection
Survey Administration
Pancreatectomy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Resectable Pancreatic Carcinoma focused on measuring pancreatectomy, Transfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female >= 18 years of age at Visit 1 Documentation of a pancreatic cancer diagnosis as evidenced by one or more clinical features meeting the following criteria: CT evidence of a mass in the pancreas consistent with cancer Tissue diagnosis of cancer either before surgery or from the resected specimen Preoperative evaluation suggestive that pancreatic resection is feasible Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Exclusion Criteria: Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data Patients who are unable to receive or who refuse blood products Patients involved in an autologous pre-donation program Patients found to have metastatic disease upon entry into abdomen-having been randomized, these patients will be removed from the study and replaced with another patient Patients found to not have cancer during the operation- If the resected lesion proves not to be cancer, the patient will remain as an enrolled patient but not evaluable and replaced by another patient Established severe cardiovascular disease with estimated 5-year survival <10% based on Framingham risk score Unstable angina or recent myocardial infarction (MI)/stroke within 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm I (Transfusion for Hgb less than 7 g/dL)

    Arm II (Transfusion for Hgb less than 9 g/dL)

    Arm Description

    Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.

    Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.

    Outcomes

    Primary Outcome Measures

    Rate of Protocol adherence
    Will be measured as the proportion of patients who are enrolled in the study and do not experience major protocol

    Secondary Outcome Measures

    Health related quality of life
    Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS)-29 v2.1. PROMIS, uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. a higher T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a higher T-score represents greater fatigue and a lower T-score represents less fatigue. For positively-worded concepts like physical function, a higher T-score reflects higher (better) physical function and a lower T-score reflects lower (worse) physical function. For NIH Toolbox performance tests of cognitive, motor, and sensory function, a higher score indicates better performance.
    Incidence of significant individual adverse events
    Will include major adverse cardiovascular events (MACE), surgical site infection (SSI), surgical site occurrence (SSO), clinically-relevant postoperative pancreatic fistula (CR-POPF), hemorrhage, pneumonia, urinary tract infection (UTI), reoperation, readmission, and mortality. Safety and tolerability data will be summarized by treatment group. Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
    Length of stay in hospital and intensive care unit (ICU)
    Proportion of patients transfused
    Number of blood products received

    Full Information

    First Posted
    April 12, 2023
    Last Updated
    August 4, 2023
    Sponsor
    Jonsson Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05841706
    Brief Title
    Red Blood Cell Transfusion Thresholds for Improved Quality of Life for Patients Undergoing a Pancreatectomy for Pancreatic Cancer
    Official Title
    Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 30, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2025 (Anticipated)
    Study Completion Date
    April 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jonsson Comprehensive Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This clinical trial tests the the feasibility of testing a red blood cell transfusion threshold for improved quality of life for patients undergoing a pancreatectomy for pancreatic cancer. Pancreatectomy can be associated with significant blood loss. Blood loss can result in clinically important anemia causing fatigue. Pancreatic cancer itself can be associated with malnutrition and fatigue. Having a red blood cell transfusion threshold that results in a more liberal use of transfusions may improve quality of life for patients undergoing a pancreatectomy for pancreatic cancer.
    Detailed Description
    PRIMARY OBJECTIVE: I. The primary objective for this pilot study is protocol adherence for the transfusion study we propose for pancreatectomy patients. SECONDARY OBJECTIVES: I. Determine the feasibility of collecting and processing of all data that will be collected in the full study. II. Specific emphasis will be given to findings from Patient Reported Outcomes Measurement Information System (PROMIS)-29 to determine its sensitivity to changes in health related quality of life (HRQOL) that occur in the perioperative period after pancreatectomy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo red blood cell transfusion if hemoglobin (Hgb) is less than 7 g/dL while on study. ARM II: Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo computed tomography (CT) scan, x ray imaging, and blood sample collection throughout the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Resectable Pancreatic Carcinoma
    Keywords
    pancreatectomy, Transfusion

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I (Transfusion for Hgb less than 7 g/dL)
    Arm Type
    Experimental
    Arm Description
    Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
    Arm Title
    Arm II (Transfusion for Hgb less than 9 g/dL)
    Arm Type
    Experimental
    Arm Description
    Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
    Intervention Type
    Biological
    Intervention Name(s)
    Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)
    Other Intervention Name(s)
    PRBC Transfusion
    Intervention Description
    Receive conservative transfusion strategy (Hgb < 7 g/dL)
    Intervention Type
    Biological
    Intervention Name(s)
    Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)
    Other Intervention Name(s)
    PRBC Transfusion
    Intervention Description
    Receive liberal transfusion strategy (Hgb < 9 g/dL)
    Intervention Type
    Procedure
    Intervention Name(s)
    Computed Tomography
    Other Intervention Name(s)
    CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, computed tomography
    Intervention Description
    Undergo CT scan
    Intervention Type
    Procedure
    Intervention Name(s)
    X-Ray Imaging
    Other Intervention Name(s)
    Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Radiographic Imaging, Radiography, RG, Static X-Ray, X-RAY, X-Ray, X-Ray, X-Ray, X-Ray
    Intervention Description
    Undergo x-ray imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    Biospecimen Collection
    Other Intervention Name(s)
    Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
    Intervention Description
    Undergo blood sample collection
    Intervention Type
    Other
    Intervention Name(s)
    Survey Administration
    Intervention Description
    Ancillary studies
    Intervention Type
    Procedure
    Intervention Name(s)
    Pancreatectomy
    Intervention Description
    surgical removal of all or part of pancreas
    Primary Outcome Measure Information:
    Title
    Rate of Protocol adherence
    Description
    Will be measured as the proportion of patients who are enrolled in the study and do not experience major protocol
    Time Frame
    Up to 36 months post surgery
    Secondary Outcome Measure Information:
    Title
    Health related quality of life
    Description
    Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS)-29 v2.1. PROMIS, uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. a higher T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a higher T-score represents greater fatigue and a lower T-score represents less fatigue. For positively-worded concepts like physical function, a higher T-score reflects higher (better) physical function and a lower T-score reflects lower (worse) physical function. For NIH Toolbox performance tests of cognitive, motor, and sensory function, a higher score indicates better performance.
    Time Frame
    At preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36
    Title
    Incidence of significant individual adverse events
    Description
    Will include major adverse cardiovascular events (MACE), surgical site infection (SSI), surgical site occurrence (SSO), clinically-relevant postoperative pancreatic fistula (CR-POPF), hemorrhage, pneumonia, urinary tract infection (UTI), reoperation, readmission, and mortality. Safety and tolerability data will be summarized by treatment group. Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
    Time Frame
    Up to 36 months post operative
    Title
    Length of stay in hospital and intensive care unit (ICU)
    Time Frame
    through study completion, an average of 1 year
    Title
    Proportion of patients transfused
    Time Frame
    Up to hospital discharge or post operative day 28
    Title
    Number of blood products received
    Time Frame
    Up to hospital discharge or post operative day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female >= 18 years of age at Visit 1 Documentation of a pancreatic cancer diagnosis as evidenced by one or more clinical features meeting the following criteria: CT evidence of a mass in the pancreas consistent with cancer Tissue diagnosis of cancer either before surgery or from the resected specimen Preoperative evaluation suggestive that pancreatic resection is feasible Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Exclusion Criteria: Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data Patients who are unable to receive or who refuse blood products Patients involved in an autologous pre-donation program Patients found to have metastatic disease upon entry into abdomen-having been randomized, these patients will be removed from the study and replaced with another patient Patients found to not have cancer during the operation- If the resected lesion proves not to be cancer, the patient will remain as an enrolled patient but not evaluable and replaced by another patient Established severe cardiovascular disease with estimated 5-year survival <10% based on Framingham risk score Unstable angina or recent myocardial infarction (MI)/stroke within 6 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarahmay Sanchez
    Phone
    3107940283
    Email
    sosanchez@mednet.ucla.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward Livingston, MD
    Organizational Affiliation
    University of California at Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Red Blood Cell Transfusion Thresholds for Improved Quality of Life for Patients Undergoing a Pancreatectomy for Pancreatic Cancer

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