Clinical trial NCT05841706: 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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Resectable Pancreatic Carcinoma
Keywords: pancreatectomy, Transfusion
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rate of Protocol adherence
timeFrame: Up to 36 months post surgery
Secondary outcomes:
measure: Health related quality of life
timeFrame: At preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36
measure: Incidence of significant individual adverse events
timeFrame: Up to 36 months post operative
measure: Length of stay in hospital and intensive care unit (ICU)
timeFrame: through study completion, an average of 1 year
measure: Proportion of patients transfused
timeFrame: Up to hospital discharge or post operative day 28
measure: Number of blood products received
timeFrame: Up to hospital discharge or post operative day 28
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
Study officials:
affiliation: University of California at Los Angeles
name: Edward Livingston, MD
role: PRINCIPAL_INVESTIGATOR
References: