3467 - Feasibility and Safety of Black Soybean Extract Cream on Radiation-Induced Dermatitis, Pain and Quality of Life in Head and Neck Cancer Patients: A Phase I, Single-Arm, Open-Label Prospective Study
Presenter(s)
H. H. Lee1,2, Y. H. Huang3, J. J. Huang4, and M. Y. Huang4,5; 1Kaohsiung Medical University, Kaohsiung City, Taiwan, 2Kaohsiung Medical University Hospital, Kaohsiung city, Taiwan, 3CGMH, Kaohsiung, Kaohsiung, Taiwan, 4Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan, 5Kaohsiung Medical University, Kaohsiung, Taiwan
Purpose/Objective(s): Radiation-induced dermatitis (RID) is one of the most common complications experienced by cancer patients undergoing radiotherapy (RT), particularly those with head and neck cancers. This condition not only causes physical discomfort but can also significantly impact a patient’s quality of life. In this study, we aimed to explore the feasibility, safety, and effectiveness of black soybean extract cream (BSEC) in managing RID, alleviating pain, and improving quality of life in this patient population.
Materials/Methods: A prospective, single-arm, open-label study was conducted, involving head and neck cancer patients undergoing RT. Participants applied BSEC topically twice daily over an 11-week period, starting 2 weeks before RT, continuing throughout the 7 weeks of RT, and extending 2 weeks post-RT. The severity of RID was assessed using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE). Pain outcomes were measured based on the intensity of the worst pain experienced, and the impact on quality of life was evaluated using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire.
Results: The mean grade of dermatitis showed no skin reactions in any of the 22 patients during the first three weeks. In the fourth week, grade 1 dermatitis was observed in 2 patients (9.01%). The mean grade of dermatitis in patients treated with BSEC gradually increased, peaking between Week 8 and 9 (mean = 0.9), and returned to 0.0 by the end of the study. Pain were evaluated using BPI-SF scores ranging from zero (no pain) to 10 (worst pain possible). The results showed that the mean worst pain intensity was 0.1 (SD = 2.9) at baseline and 1.7 (SD = 2.4) during the RT period. Throughout the study, the mean worst pain scores remained relatively stable, ranging from 0 to 1.2, and peaked in Week 9. Furthermore, the pain intensity was categorized as none, mild, moderate, and severe based on the worst pain scores of the BPI-SF questionnaire (0: no pain, 1-4: mild pain, 5-6: moderate pain, 7-10: severe pain). Generally, patients treated with BSEC reported no or only mild pain over time. Moderate and severe pain were observed only from Week 8 to 10, with an overall incidence of less than 10%. A responder analysis of the worst pain rating throughout the study period was conducted. A responder was defined as a patient whose highest worst pain scores were less than or equal to 4. Patients treated with BSEC had a responder rate of 81.8% (95% CI: 59.7 ~ 94.8%) for worst pain rating. From BPI-SF results, patients treated with BSEC showed mean scores of 0.4, 0.3, and 0.5 for general activity in Week 9, 10, and 11, respectively. All results revealed that patients using BSEC exhibited a lower severity of dermatitis, reduced levels of pain, and minimal disruption to their quality of life.
Conclusion: These findings suggest that BSEC is a promising adjunctive therapy for managing RT-associated skin complications and improving patient well-being.