NAVAH for Cancer

Overseen By Shearwood McClelland III, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Non-African-American, No breast/prostate cancer

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

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a more convenient radiation therapy schedule for African-American women with breast cancer. The goal is to make it easier for them to complete their treatment and improve their chances of recovery. This approach would benefit women with early breast cancer treated with breast conserving surgery.

Do I need to stop my current medications for the NAVAH for Cancer trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What safety data exists for NAVAH treatment in clinical trials?

The research articles do not provide specific safety data for NAVAH treatment. They discuss general safety monitoring and adverse event reporting in clinical trials, but there is no direct mention of NAVAH or its safety profile. ^{1 2 3 4 5}

Research Team

Shearwood McClelland III, MD

Principal Investigator

University Hospitals Cleveland Medical Center Seidman Cancer Center

Eligibility Criteria

This trial is specifically for African-American adults over 18 with confirmed breast or prostate cancer. Participants must be able to give informed consent and understand the study requirements. It's not open to individuals who are not of African-American ethnicity or those without a confirmed diagnosis.

Inclusion Criteria

Subjects must be of African-American race

My cancer in the breast or prostate has been confirmed by lab tests.

I am older than 18 years.

Exclusion Criteria

Subjects NOT of African-American ethnicity

I do not have confirmed breast or prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy Simulation

Navigator discussion with patients prior to the start of radiation therapy simulation and administration of survey after completion of simulation

1 week

1 visit (in-person)

Radiation Therapy

Participants receive navigator-assisted hypofractionation radiation therapy

4-6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including administration of post-treatment and financial toxicity surveys

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• NAVAH

Trial Overview The NAVAH intervention is being tested to see if it can improve the completion rates of radiation therapy among African-American patients with breast or prostate cancer, addressing disparities in access to optimal cancer care.

Participant Groups

Group I: Navigator-Assisted Hypofractionation (NAVAH) Experimental Treatment 1 Intervention

This pilot cohort study is designed as follows: 1. Navigator discussion with patients prior to the start of radiation therapy simulation (15-30 minutes). 2. Navigator administration of survey with patients after completion of radiation therapy simulation but before the start of radiation therapy (30-45 minutes) 3. Navigator administration of post-treatment survey and financial toxicity survey instrument after the completion of radiation therapy (60 minutes).

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Susan G. Komen Breast Cancer Foundation

Collaborator

Trials

68

Recruited

220,000+

Findings from Research

The North Central Cancer Treatment Group developed a real-time toxicity reporting system to enhance the monitoring of severe side effects in NCI-sponsored clinical trials, aiming to improve patient safety.

This system has been effective in monitoring phase II and III trials, such as the N9741 study on advanced colorectal cancer, allowing for timely modifications to ongoing clinical trials based on reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. Goldberg, RM., Sargent, DJ., Morton, RF., et al.[2016]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

In a study of 373 patients from 11 phase I clinical trials, ipilimumab-related grade 3/4 adverse events were more common in patients who responded to treatment, indicating a potential link between therapeutic response and toxicity.

The likelihood of experiencing severe adverse events increased with the number of additional agents used alongside ipilimumab, while longer treatment duration was associated with more low-grade toxicities but not high-grade ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic and predictive factors associated with ipilimumab-related adverse events: a retrospective analysis of 11 NCI-sponsored phase I clinical trials. Chauhan, A., Kabir, T., Wu, J., et al.[2023]

In a study of 66 patients with operable stage III non-small cell lung cancer (NSCLC), the combination of Camrelizumab with Docetaxel and Cisplatin showed good overall safety, with most adverse events (AEs) being mild (grade 1-2) and only 9.1% being severe (grade 3-4).

The supervision of adverse events during neoadjuvant therapy not only helped in managing complications but also led to an improvement in patients' quality of life, indicating that careful monitoring can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. Zhang, Y., Zhou, S., Tao, W., et al.[2023]

The number of post-authorization safety and effectiveness studies (PASSs/PAESs) for oncology drugs has significantly increased, from just 1 study between 2006-2010 to 47 studies from 2016-2020, indicating a growing emphasis on real-world evidence for drug safety and effectiveness.

Most of these studies (64.1%) focused on safety/risk assessment, particularly regarding adverse events, while effectiveness studies primarily aimed at measuring overall survival, highlighting the need for more comparative analyses in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulator-Requested Non-Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review. Zhang, X., Chen, L., Bracco, OL., et al.[2022]

References

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

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. [2016]

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

Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]

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

Prognostic and predictive factors associated with ipilimumab-related adverse events: a retrospective analysis of 11 NCI-sponsored phase I clinical trials. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. [2023]

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

Regulator-Requested Non-Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review. [2022]