scholarly journals Comparative Efficacy of Jaungo, A Traditional Herbal Ointment, and the Water-in-Oil Type Non-Steroidal Moisturizer for Radiation-Induced Dermatitis in Patients With Breast Cancer: A Study Protocol for a Prospective, Randomized, Single-Blinded, Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Eun Hye Kim ◽  
Jee-Hyun Yoon ◽  
Su Bin Park ◽  
Jee Young Lee ◽  
Weon Kuu Chung ◽  
...  

Background: Radiation-induced dermatitis (RID) is a common complication of radiation therapy (RT). Although it has a high prevalence and can even trigger the premature end of conventional cancer therapies, there is no standard management. This study aims to evaluate whether topical use of Jaungo (Shiunko), a traditional herbal ointment mainly composed of Lithospermi radix and Angelica sinensis, could reduce RID compared to the water-in-oil type non-steroidal moisturizer in patients with breast cancer.Methods: This is a prospective, single-blinded, randomized controlled pilot trial that investigates the effect of topical application of Jaungo for the prevention of RID in postoperative breast cancer patients scheduled for RT, in comparison with the non-steroidal moisturizer, with a random distribution of 50 patients across the two groups. RT will be administered for 5–7 weeks with a biological equivalent dose (BED10) of 60 Gy or more, and the interventions will be applied 3 times a day during RT duration. Participants will be assessed a total of nine times, including eight visits during the period of RT and one visit at a 2-week follow-up period after the end of treatment. The incidence and severity of RID, quality of life, skin reaction symptoms, and maximum pain related to RID will be measured. The incidence rate of grade 2 or higher RID using the Radiation Therapy Oncology Group (RTOG) in the two groups will be statistically compared as the primary outcome. The types and frequencies of adverse events will be also collected and evaluated. All assessments will be performed by independent radiology oncologists.Discussion: This trial is currently ongoing and is recruiting. This study will determine the preventive efficacy of Jaungo in RID with postoperative breast cancer patients and provide evidence in traditional Korean medicine clinical practice.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12567-e12567
Author(s):  
Hao Yu ◽  
Fang Chen ◽  
Li Yang ◽  
Jian-Yue Jin ◽  
Feng-Ming Spring Kong

e12567 Background: Radiation-induced lymphopenia accompanied with radiation therapy is associated with inferior clinical outcomes in a wide variety of solid malignancies. This study aimed to examine the potential determines of radiation-induced lymphocyte decrease and radiation-induced lymphopenia in breast cancer patients who underwent radiotherapy. Methods: Patients with breast cancer treated who underwent radiotherapy were enrolled in University of Hong Kong-Shenzhen Hospital (our cohort). Circulating lymphocyte levels were evaluated within 7 days prior to and end of radiation therapy. Feature groups including clinical data, tumor characteristics, radiotherapy dosimetrics, treatment regiments were also collected. We applied machine learning algorithms (Extreme Gradient Boosting, XGboost) to predict the ratio of lymphocyte level after radiotherapy to baseline lymphocyte level and the event of lymphopenia and compared with Lasso regression approaches. Next, we used Shapley additive explanation (SHAP) to explore the directional contribution of each feature for lymphocyte decrease and lymphopenia. For the purpose of model validation and proof-of-concept validation, an independent cohort of patients enrolled in prospective trial was eligible (IP cohort). Results: A total of 589 patients were enrolled in our cohort and 203 patients in IP cohort. XGboost models which trained in our cohort with performances of a mean RMSE: 0.157 and R2: 53.9% for the ratio of lymphocyte levels; a mean accuracy: 0.757 and ROC-AUC: 0.733 for the lymphopenia events, separately. These models can predict the ratio of lymphocyte levels with a mean RMSE: 0.175 and R2: 47%; predict the lymphopenia events with a mean accuracy: 0.739 and ROC-AUC: 0.737 in the totally independent IP cohort. The feature group of dosimetrics had the largest predictive power with RMSE: 0.192, R2: 29.8%, accuracy: 0.678 and ROC-AUC: 0.667; followed by the group of baseline blood cells with predictive power as RMSE: 0.207, R2: 18.9%, accuracy: 0.669 and ROC-AUC: 0.645. Next, by SHAP value analysis, we investigated that integral dose of the total body, V5 dose, mean lung dose and V20 dose of ipsilateral lung/bilateral lungs were in consequence important promote factors for lymphocyte decrease and for the event of lymphopenia, while the features of baseline monocyte, mean heart dose and tumor size played a role of protection at some extend. Conclusions: In this study, we constructed robust XGboost models for predicting the lymphocyte decrease and the event of lymphopenia in breast cancer patients who underwent radiation therapy. We also applied SHAP analysis for revealing the directional contribution of features. These results are important either for the understanding the contributions of dosimetrics on immune response or for the refine of radiation dosimetrics before treatment in future clinical usages.


2018 ◽  
Vol 17 (5) ◽  
pp. 37-44
Author(s):  
G. V. Afonin ◽  
Y. A. Ragulin ◽  
I. А. Gulidov ◽  
Е. E. Beketov ◽  
A. D. Kaprin

The purpose of the studywas to evaluate the efficacy and safety of hypofractionated postoperative radiation therapy (2.7 Gy per fraction in 15 fractions to a total dose of 40.5 Gy) in comparison with the standard fractionation regimen.Material and methods.The study included 321 patients diagnosed with stage I–IIIA breast cancer treated in the A. Tsyb Medical Radiological Research Center from 2013 to 2017. The patients were divided into two groups. Group I patients received hypofractionated postoperative radiotherapy at a total dose of 40.5 Gy in 15 fractions with Gy 2.7 Gy/fraction (n=223). Group II patients received conventional radiotherapy at a total dose of 50 Gy in 25 fractions with 2 Gy/fraction (n=98). Both groups were comparable in terms of the stage of the disease and molecular subtype of the tumor. The statistical analysis of the main characteristics of the studied regimens was carried out.Results.The analysis revealed no significant differences in the overall survival (OS) and disease-free survival (DFS) between two groups. The frequency of acute radiation-induced complications (grade 1 and 2) in Groups I and II were 79 % and 84 %, respectively. Late radiation-induced side effects were observed less frequently in patients treated with hypofractionated postoperative radiotherapy than in the control group patients (23 % versus 43 %, p<0.01). Severe post-radiation damage to normal tissues was not found. The extent of surgery did not affect the long-term treatment outcomes.Conclusion.Comparison of hypofractionated radiotherapy with conventional radiotherapy in breast cancer patients demonstrated the superiority of hypofractionated radiotherapy regimen in terms of late toxicity and economic profitability. Further studies of accelerated fractionated postoperative radiotherapy are required to improve the treatment outcomes in breast cancer patients.


2020 ◽  
Vol 6 (2) ◽  
pp. 138-148 ◽  
Author(s):  
Afrin Sultana Chowdhury ◽  
Saheda Tamanna

Breast cancer is the most frequent malignancy and the leading cause of cancer morbidity and mortality in women worldwide. Radiation therapy (RT) is a widely used approach for its treatment. About 50% of patients with malignant breast tumors receive radiation therapy and most of them appear to tolerate it, but some experience severe side effects induced by this therapy. This variability of response may be caused by several factors, like age, inflammatory responses, body weight and variation in genes involved in the response to radiation-induced DNA damage. To limit radiotherapy side effects in breast cancer patients it is therefore important to have a good knowledge of these associated factors. This review discussed about the radiotherapy-related side effects in breast cancer patients and the factors affecting them. Asian J. Med. Biol. Res. June 2020, 6(2): 138-148


2020 ◽  
Vol 62 (1) ◽  
pp. 110-118
Author(s):  
Isabel Linares-Galiana ◽  
Miguel Angel Berenguer-Frances ◽  
Rut Cañas-Cortés ◽  
Monica Pujol-Canadell ◽  
Silvia Comas-Antón ◽  
...  

Abstract A detailed understanding of the interactions and the best dose-fractionation scheme of radiation to maximize antitumor immunity have not been fully established. In this study, the effect on the host immune system of a single dose of 20 Gy through intraoperative radiation therapy (IORT) on the surgical bed in low-risk breast cancer patients undergoing conserving breast cancer has been assessed. Peripheral blood samples from 13 patients were collected preoperatively and at 48 h and 3 and 10 weeks after the administration of radiation. We performed a flow cytometry analysis for lymphocyte subpopulations, natural killer cells (NK), regulatory T cells (Treg) and myeloid-derived suppressor cells (MDSCs). We observed that the subpopulation of NK CD56+high CD16+ increased significantly at 3 weeks after IORT (0.30–0.42%, P &lt; 0.001), while no changes were found in immunosuppressive profile, CD4+CD25+Foxp3+Helios+ Treg cells, granulocytic MDSCs (G-MDSCs) and monocytic MDSCs (Mo-MDSCs). A single dose of IORT may be an effective approach to improve antitumor immunity based on the increase in NK cells and the non-stimulation of immunosuppressive cells involved in immune escape. These findings support future combinations of IORT with immunotherapy, if they are confirmed in a large cohort of breast cancer patients.


2006 ◽  
Vol 117 (2) ◽  
pp. 359-365 ◽  
Author(s):  
Jeffrey A. Ascherman ◽  
Matthew M. Hanasono ◽  
Martin I. Newman ◽  
Duncan B. Hughes

Sign in / Sign up

Export Citation Format

Share Document