Red Blood Cell Transfusions for Pancreatic Cancer

Overseen By Melissa Arevalo

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Pregnant, Metastatic disease, Severe cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if varying levels of red blood cell transfusions can enhance the quality of life for individuals undergoing surgery to remove part of their pancreas due to cancer. Pancreatic cancer surgery often results in significant blood loss, leading to anemia (low red blood cell count) and fatigue. The trial will compare two groups: one receiving transfusions at a lower blood level and another at a slightly higher level. Individuals diagnosed with pancreatic cancer and scheduled for surgery may be suitable candidates for this trial. As an Early Phase 1 trial, this research seeks to understand how the treatment functions in people, offering participants an opportunity to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that blood transfusions during surgery for pancreatic cancer yield mixed results. Some studies suggest that patients receiving these transfusions might experience worse long-term outcomes, including a higher risk of death from any cause, as well as from cancer. However, the reasons for these outcomes remain unclear.

On the positive side, blood transfusions can alleviate anemia, a condition characterized by too few red blood cells, which can result from surgery or the cancer itself and cause fatigue and other symptoms.

This trial tests two different thresholds for transfusions. One group will receive a transfusion when hemoglobin levels fall below 7 g/dL, and the other when levels fall below 9 g/dL. The researchers aim to determine which approach might improve quality of life without increasing risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for pancreatic cancer, which typically includes chemotherapy and sometimes radiation or surgery, the red blood cell transfusion protocol being tested is unique because it focuses on addressing anemia in patients. Researchers are excited about this approach because it could improve patients' overall health and energy levels by maintaining a higher hemoglobin threshold. By comparing two different hemoglobin levels (less than 7 g/dL and less than 9 g/dL) for transfusion, this study could reveal optimal strategies for managing anemia in pancreatic cancer patients, potentially enhancing their quality of life during treatment.

What evidence suggests that this trial's red blood cell transfusion treatments could be effective for improving quality of life in pancreatic cancer patients?

This trial will compare two different thresholds for red blood cell transfusions in patients with pancreatic cancer. Research has shown that blood transfusions can affect people with pancreatic cancer in various ways. Some studies suggest that these transfusions can help treat anemia, a condition marked by low red blood cell count that often causes fatigue. This can be particularly beneficial for patients undergoing surgery, such as a pancreatectomy, where significant blood loss may occur. However, other studies have found a potential link between blood transfusions and shorter survival times for pancreatic cancer patients. The reasons for this remain unclear. Patients should carefully weigh these benefits and risks when considering participation in a trial. ^{1 6 7 8 9}

Who Is on the Research Team?

Edward Livingston, MD

Principal Investigator

University of California at Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults over 18 with CT evidence of pancreatic cancer and a tissue diagnosis confirming the disease. Candidates should be evaluated as suitable for pancreatic surgery and must provide written consent to participate.

Inclusion Criteria

My CT scan shows a mass in the pancreas that may be cancer.

You (or your legal guardian) have given permission for you to participate in the study and can follow the study rules.

My doctors think surgery to remove my pancreas is possible.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo red blood cell transfusion based on hemoglobin levels, along with CT scan, x-ray imaging, and blood sample collection

Up to 36 months

Regular visits for transfusion and monitoring

Follow-up

Participants are monitored for safety, adverse events, and quality of life using PROMIS-29

36 months

Visits at months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36

What Are the Treatments Tested in This Trial?

Interventions

• Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)
• Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)

Trial Overview

The study tests two different red blood cell transfusion strategies (using lower or higher hemoglobin levels as triggers) in patients undergoing pancreatectomy for pancreatic cancer, aiming to see which improves quality of life.

How Is the Trial Designed?

Group I: Arm II (Transfusion for Hgb less than 9 g/dL) Experimental Treatment 6 Interventions

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.

Group II: Arm I (Transfusion for Hgb less than 7 g/dL) Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Published Research Related to This Trial

In a study of 214 childhood cancer survivors, higher treatment intensity was linked to an increased need for packed red blood cell (PRBC) transfusions, which raises the risk of iron overload.

Younger age and lower hemoglobin levels at diagnosis were found to be associated with a greater iron burden, highlighting the need for monitoring iron levels in patients receiving intensive cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of projected transfusional iron burden with treatment intensity in childhood cancer survivors. Ruccione, KS., Mudambi, K., Sposto, R., et al.[2012]

An international consensus of 39 clinical experts established guidelines for packed red blood cell (PRBC) transfusion practices in cervical cancer patients undergoing radiotherapy, emphasizing a hemoglobin target of 9 g/dL or more but less than 12 g/dL to optimize treatment outcomes.

No specific hemoglobin transfusion threshold was agreed upon for different types of radiotherapy, highlighting the need for further randomized clinical trials to determine the best transfusion practices for maximizing patient benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red Blood Cell Transfusion Practices for Patients With Cervical Cancer Undergoing Radiotherapy. Zayed, S., Nguyen, TK., Lin, C., et al.[2021]

In a study of 360 children who underwent surgery for solid tumors, those who received packed red blood cell (PRBC) transfusions had a higher risk of postoperative infections and tumor recurrence, indicating potential risks associated with transfusions in this population.

Each additional unit of PRBC transfused increased the odds of postoperative infection by nearly four times, suggesting that if transfusions are necessary, they should be given in single unit increments to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Transfusion is Associated With Adverse Outcomes in Pediatric Solid Tumor Oncology Patients Following Tumor Resection. Acker, SN., Nolan, MM., Prendergast, C., et al.[2023]

In a study of 53 pediatric patients in the PICU, packed red blood cell (PRBC) transfusions significantly improved cerebral oxygenation, as indicated by increased cerebral near-infrared spectroscopy (cNIRS) values after transfusion.

The transfusions also led to a decrease in cerebral tissue fractional oxygen extraction (CTFOE) and variability in cNIRS (cNIRS-VI), suggesting enhanced oxygen delivery to the brain without being affected by the age of the PRBCs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring of near-infrared spectrum values during packed red blood cell transfusion in pediatric intensive care unit. Ceylan, G., Sandal, O., Sari, F., et al.[2021]

In a study of 1129 patients with surgically resected pancreatic neuroendocrine tumors (PNETs), 13.8% received packed red blood cell (PRBC) transfusions, which were linked to worse overall survival (OS) and recurrence-free survival (RFS).

Transfused patients had a median OS of 116 months compared to 150 months for non-transfused patients, and multivariable analysis indicated that PRBC transfusion increased the risk of worse OS by 80%, highlighting the potential negative impact of transfusions on survival outcomes in PNET patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of perioperative blood transfusion on survival in pancreatic neuroendocrine tumor patients: analysis from the US Neuroendocrine Study Group. Marincola Smith, P., Baechle, J., Solórzano, CC., et al.[2023]

Low preoperative hemoglobin levels and extended resections are significant risk factors for the need for perioperative transfusion of packed red blood cells (pRBCs) in patients undergoing pancreaticoduodenectomy, as identified in a study of 101 patients.

The study also found that preoperative BMI and the derived propensity model for pRBC transfusion are independent risk factors for survival, suggesting that improving hemoglobin levels and addressing malnutrition could enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative hemoglobin levels, extended resections and the body mass index influence survival after pancreaticoduodenectomy. Panagiotakis, E., Selzer, T., Böhm, G., et al.[2023]

In a study of 442 patients undergoing liver or pancreas surgery for cancer, those who received packed red blood cell (PRBC) transfusions had significantly worse overall survival (OS) and recurrence-free survival (RFS), especially with higher transfusion volumes.

Implementing a restrictive transfusion strategy did not improve long-term outcomes, but it may help conserve blood resources and reduce unnecessary risks associated with transfusions in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of blood transfusions and transfusion practices on long-term outcome following hepatopancreaticobiliary surgery. Ejaz, A., Spolverato, G., Kim, Y., et al.[2018]

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