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

Resectable Pancreatic Carcinoma Clinical Trial

Official title:

Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841706
• Other study ID #: 22-001796
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 10, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: January 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: Sarahmay Sanchez
• Phone: 3107940283
• Email: sosanchez[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Resectable Pancreatic Carcinoma

Intervention

Biological:
• Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)
Receive conservative transfusion strategy (Hgb < 7 g/dL)
• Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)
Receive liberal transfusion strategy (Hgb < 9 g/dL)

Procedure:
• Computed Tomography
Undergo CT scan
• X-Ray Imaging
Undergo x-ray imaging
• Biospecimen Collection
Undergo blood sample collection

Other:
• Survey Administration
Ancillary studies

Procedure:
• Pancreatectomy
surgical removal of all or part of pancreas

Locations

Country	Name	City	State
United States	University of California at Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Protocol adherence	Will be measured as the proportion of patients who are enrolled in the study and do not experience major protocol	Up to 36 months post surgery
Secondary	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.	At preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36
Secondary	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.	Up to 36 months post operative
Secondary	Length of stay in hospital and intensive care unit (ICU)		through study completion, an average of 1 year
Secondary	Proportion of patients transfused		Up to hospital discharge or post operative day 28
Secondary	Number of blood products received		Up to hospital discharge or post operative day 28