Autologous Blood Patch for Lung Cancer

Overseen By Abigail Goerge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Pneumonectomy, Sleeve lobectomy, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 days

60 Participants Needed

Trial Summary

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 coordinators or your doctor.

Is the autologous blood patch generally safe for humans?

The autologous blood patch has been used to treat air leaks after lung surgery and is considered to have minimal risk based on available studies. It has been applied successfully in many cases with few complications reported, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does the Autologous Blood Patch treatment for lung cancer differ from other treatments?

The Autologous Blood Patch treatment is unique because it uses the patient's own blood to create a patch, which is different from standard treatments like chemotherapy or targeted therapies that use drugs to attack cancer cells. This approach may offer a novel way to manage lung cancer by potentially sealing air leaks in the lungs, which is not addressed by conventional treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

A postoperative autologous blood patch (ABP) intervention trial for patients who underwent lung resection for cancer to examine its effectiveness in preventing a prolonged air leak. AIM 1: To determine the safety and efficacy of autologous blood patch (ABP) as a means to reduce the rate of prolonged air leak (PAL) after lung cancer resection AIM 2: To prospectively examine variation in morbidity and quality of life between patients with and without a PAL

Research Team

Christopher W Seder, MD

Principal Investigator

Rush University Medical Center

Sebastien Gilbert, MD

Principal Investigator

University of Ottawa

Eligibility Criteria

This trial is for adults over 18 who had lung cancer surgery and have an air leak on the third day after their operation. It's not for those who had more extensive surgeries like pneumonectomy, or women who are pregnant.

Inclusion Criteria

I had surgery to remove part of my lung for suspected lung cancer.

Patients that have reviewed and signed the Informed Consent Form, had an opportunity to ask questions, and consent to have their de-identified data included in the study

I have an air leak from my surgery site on the third day after surgery.

Exclusion Criteria

I am currently pregnant.

I have had surgery to remove a lung, part of a lung, chest wall, diaphragm, or had surgery on both sides of my chest.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous blood patch intervention on postoperative day 3 and possibly day 4

2 days

In-person visits on postoperative days 3 and 4

Follow-up

Participants are monitored for safety and effectiveness after treatment, including questionnaire completion

30 days

Follow-up in clinic or via telephone

Treatment Details

Interventions

• Autologous Blood Patch
• Standard of Care

Trial Overview The study tests if using a patient's own blood to create a patch (ABP) can prevent leaks in the lungs after cancer surgery. Patients will either get this new treatment or the usual care, and researchers will compare how well each works.

Participant Groups

Group I: Autologous Blood Patch Experimental Treatment 1 Intervention

60-120ml of patient's blood will be drawn and inserted into patient's chest tube. A minimum of 60ml of blood is required, with the optimal amount of blood being 120ml.

Group II: Standard of Care (Per physician) Active Control 1 Intervention

Chest tube remains intact without blood patch.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Findings from Research

In a study involving 987 patients with advanced non-small-cell lung cancer (NSCLC), bevacizumab combined with platinum-based chemotherapy showed a median progression-free survival of 7.4 months and an overall response rate of 45.6%, confirming its effectiveness as a first-line treatment.

The safety profile of bevacizumab was consistent with previous studies, with 33.6% of patients experiencing grade ≥3 adverse drug reactions, primarily leukopenia, neutropenia, and hypertension, but no new safety concerns were identified, indicating it is well tolerated even after more than 20 treatment cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVAiLABLE NIS - AVASTIN® in lung cancer treatment in routine oncology practice in Germany. Zahn, MO., Linck, D., Losem, C., et al.[2020]

In a phase 3 trial involving 1501 patients with early-stage non-small-cell lung cancer (NSCLC), the addition of bevacizumab to standard adjuvant chemotherapy did not improve overall survival compared to chemotherapy alone, with a median follow-up of 50.3 months.

While bevacizumab was associated with higher rates of grade 3-5 toxicities, including hypertension and neutropenia, the overall survival rates were similar between the two treatment groups, indicating that bevacizumab should not be used as an adjuvant therapy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial. Wakelee, HA., Dahlberg, SE., Keller, SM., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Dataset of a study investigating autologous blood patch pleurodesis in postoperative prolonged air leaks after lung resection. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Autologous Blood Patching to Mitigate Persistent Air Leaks Following Pulmonary Resection: A Novel Approach. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Autologous Blood Patch Pleurodesis: A Large Retrospective Multicenter Cohort Study. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Autologous Blood Pleurodesis: What Is the Optimal Time Interval and Amount of Blood? [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of an Autologous Blood Patch for Prolonged Air Leak: A Systematic Review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

AVAiLABLE NIS - AVASTIN® in lung cancer treatment in routine oncology practice in Germany. [2020]

7. France pubmed.ncbi.nlm.nih.gov

[Treatment of metastatic non small cell lung cancer]. [2009]

8. France pubmed.ncbi.nlm.nih.gov

[Recent development of the standards of treatment of lung cancer]. [2007]

9. England pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Multimodality therapy for non-small-cell lung cancer. [2005]