NCT05978232

NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients

Completed NA Last updated 5 November 2025

What this trial tests

NA trial testing NAVAH in Breast Cancer in 30 participants. Completed in 3 November 2025.

Timeline

1 July 2023

Primary endpoint
3 November 2025

3 November 2025

Quick facts

Lead sponsor	Case Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	1 July 2023
Primary completion	3 November 2025
Estimated completion	3 November 2025
Sites	1 location across United States

Drugs / interventions tested

• NAVAH

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

African-Americans have disparately limited access to optimal cancer care. They have the highest overall cancer death rate and shortest survival time of any racial or ethnic group in the United States. Elucidation of disparities in access to cancer care are important since previous work has indicated that when equal access to RT in Radiation Therapy Oncology Group (RTOG) prospective randomized trials is granted, race does not independently affect outcomes, a finding similar to work conducted in Level I evidence-proven optimal management of curable neurologic conditions. Breast cancer is the most common cancer in African-American women and Prostate cancer is the most common cancer in African-American men. African-American breast \& prostate cancer participants are less likely to receive standard-of-care radiation therapy.

Previous work has identified that compared to Caucasian women with breast cancer, African-American women are 48% more likely to have RT omission during treatment, 167% less likely to receive timely completion of RT after breast-conserving surgery, 40% less likely to complete RT, and significantly more likely to experience RT treatment delays. Shorter course radiation therapy may reduce disparities in radiation therapy care facing African-American breast cancer participants.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Racial disparity in prostate cancer: an outlook in genetic and molecular landscape.
   Kaushal JB, Raut P, Muniyan S, Siddiqui JA, et al · · 2024 · cited 4× · PMID 38902476 · DOI 10.1007/s10555-024-10193-8
2. Medical Racism and Physician Trust Impressions of African-American Breast Cancer Patients Enrolled on the Navigator-Assisted Hypofractionation (NAVAH) Phase I Clinical Trial.
   Davis KJ, Burnette UJ, Sun Y, Stephens MJ, et al · · 2025 · cited 3× · PMID 40025854 · DOI 10.1097/coc.0000000000001183
3. Quantification of Postdiagnosis Cancer Patient Navigation.
   Posani S, Burnette UJ, McClelland S. · · 2025 · cited 1× · PMID 40525892 · DOI 10.1097/coc.0000000000001225
4. Longitudinal Impact of Adjuvant Radiation Therapy on Financial Toxicity in African-American Breast Cancer Patients: Early Findings From the Navigator-Assisted Hypofractionation (NAVAH) Program Phase I Clinical Trial.
   Stephens MJ, Burnette UJ, Kasliwal N, Onyewadume L, et al · · 2025 · PMID 41267698 · DOI 10.7759/cureus.94976
5. Impact of Patient Navigation on Radiation Therapy Completion in Black Breast Cancer Patients: Early Phase I Trial Results From the Navigator-Assisted Hypofractionation (NAVAH) Program.
   McClelland S, Burnette U, Onyewadume L, Smith TK, et al · · 2026 · PMID 41091946 · DOI 10.1097/coc.0000000000001257
6. Early Implementation of the Navigator-Assisted Hypofractionation (NAVAH) Program in Hispanic-American Breast Cancer Patients.
   McClelland Iii S, Sanchez-Feliciano A, Davila N, Smith TK, et al · · 2025 · PMID 40486385 · DOI 10.7759/cureus.83727