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Trials Jan 2024Dermatitis is a skin condition caused by multiple causes, including radiotherapy treatment. Pharmacological treatments can become chronic and are not exempt from side... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials).
BACKGROUND
Dermatitis is a skin condition caused by multiple causes, including radiotherapy treatment. Pharmacological treatments can become chronic and are not exempt from side effects. The latest recommendations of the American Academy of Dermatology establish the use of natural, nourishing, and moisturizing cosmetic products as prevention and the first therapeutic step for dermatitis. Alantel® is a cream developed to reduce redness and irritation, promote the local immune system, combat immunosenescence, and promote the healing of epidermal lesions. The objective was to evaluate the effect of a cream (Alantel) based on natural products at high concentrations for the preventive and curative treatment (at early stages) of radiation-induced dermatitis in patients with breast cancer.
METHODS
Our protocol is an experimental, prospective, triple-blind, multicenter, controlled clinical trial with two parallel arms. The experimental group will be treated with Alantel, while the control group will receive another moisturizing cream. Radiotherapy oncology professionals will recruit a total of 88 patients (44 per comparison group) with breast cancer who will receive radiotherapy oncology treatment for 15 days, and they will be randomly allocated to the experimental or control group. Selected patients will be followed up for four visits by primary care physicians for up to 1 week after completion of radiotherapy. The main study variable will be the incidence rate of mild post-radiation dermatitis. An intention-to-treat analysis will be performed, applying a comparison test for independent means and proportions. A bivariate and multivariate analysis will also be developed to check the treatment effect, adjusting for predictive sociodemographic and clinical variables.
DISCUSSION
By carrying out this clinical trial, it is expected to verify that Alantel cream, based on natural products at high concentrations, has advantages over a moisturizing cream for the preventive and curative treatment of RD in patients with breast cancer. The COVID-19 pandemic has been influenced by delaying the start of the study. One of the main limitations of this study will be the time required to recruit the patients from the planned sample, given that the selection criteria are restrictive and, although the study is multicenter, recruitment will be coordinated through a single service on radiotherapy oncology.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04116151 . Registered on 4 October 2019.
Topics: Humans; Female; Aloe; Thymus Plant; Breast Neoplasms; Chamomile; Pandemics; Prospective Studies; Radiodermatitis; Biological Products; Treatment Outcome
PubMed: 38273379
DOI: 10.1186/s13063-024-07901-8 -
Technology in Cancer Research &... 2024Radiotherapy (RT) is commonly used in the treatment of breast cancer and often, despite advances in fractionated dosing schedules, produces undesirable skin toxicity.... (Randomized Controlled Trial)
Randomized Controlled Trial
Radiotherapy (RT) is commonly used in the treatment of breast cancer and often, despite advances in fractionated dosing schedules, produces undesirable skin toxicity. The purpose of this study was to evaluate the feasibility of using a keratin-based topical cream, KeraStat® Cream (KC; KeraNetics, Inc., Winston Salem, NC, USA) to manage the symptoms of radiation dermatitis (RD) in breast cancer patients undergoing RT. A total of 24 subjects were enrolled on this single-center, randomized, open-label study. Participants were randomly assigned to KC or standard of care (SOC, patient's choice of a variety of readily available creams or moisturizers). Patients were asked to apply the assigned treatment to the irradiated area twice daily, beginning with day 1 of RT, through 30 days post-RT. The primary outcome was compliance of use. Secondary outcomes included safety and tolerability of KC, as well as RD severity assessed using the Radiation Therapy Oncology Group (RTOG) scale and the patient-reported Dermatology Life Quality Index (DLQI). All subjects in the KC group were assessed as compliant with no adverse events. The rate of RTOG Grade 2 RD was lower in the KC group (30.8%) compared to the SOC group (54.5%, = .408). At the final RT visit, the mean RTOG RD score was lower in the KC group (1.0) versus the SOC group (1.4). Similarly, patient-reported quality of life measured by the DLQI at the end of RT was improved in the KC group (mean 4.25, small effect) versus the SOC group (mean 6.18, moderate effect, = .412). KC was safe and well tolerated with no adverse events. Though efficacy measures were not powered to draw definitive conclusions, trends and clinical assessments suggest that there is a benefit of using KC compared to SOC for breast cancer patients treated with RT, and a larger powered study for efficacy is warranted. This clinical trial is registered as NCT03374995 titled KeraStat(R) Cream for Radiation Dermatitis.
Topics: Humans; Female; Keratins; Pilot Projects; Breast Neoplasms; Quality of Life; Radiodermatitis
PubMed: 38186361
DOI: 10.1177/15330338231222137 -
Radiation Oncology Journal Dec 2023Radiation recall presents as an acute inflammatory reaction triggered by systemic therapy, usually chemotherapy, and is typically limited to an area that was previously...
Radiation recall presents as an acute inflammatory reaction triggered by systemic therapy, usually chemotherapy, and is typically limited to an area that was previously irradiated. Radiation recall reactions are generally self-limiting and most commonly occur in the skin. Many systemic agents have been described to elicit a radiation recall reaction, but the exact pathogenesis is largely unknown. Here, we describe the first reported case of radiation recall dermatitis following cetuximab. While cetuximab is associated with other skin reactions, oncologists should not exclude radiation recall dermatitis as a potential complication of cetuximab infusion in patients with prior radiation, and special attention should be paid to the pattern of skin changes both in terms of location and chronology.
PubMed: 38185934
DOI: 10.3857/roj.2023.00577 -
International Journal of Molecular... Nov 2023Radiation dermatitis (RD) is one of the most common side effects of radiation therapy. However, to date, there is a lack of both specific treatments for RD and validated...
Radiation dermatitis (RD) is one of the most common side effects of radiation therapy. However, to date, there is a lack of both specific treatments for RD and validated experimental animal models with the use of various sources of ionizing radiation (IR) applied in clinical practice. The aim of this study was to develop and validate a model of acute RD induced using proton radiation in mice. Acute RD (Grade 2-4) was obtained with doses of 30, 40, and 50 Gy, either with or without depilation. The developed model of RD was characterized by typical histological changes in the skin after irradiation. Moreover, the depilation contributed to a skin histology alteration of the irradiated mice. The assessment of animal vital signs indicated that there was no effect of proton irradiation on the well-being or general condition of the animals. This model can be used to develop effective therapeutic agents and study the pathogenesis of radiation-induced skin toxicity, including that caused by proton irradiation.
Topics: Animals; Mice; Protons; Radiodermatitis; Skin; Acute Radiation Syndrome; Models, Theoretical
PubMed: 38003561
DOI: 10.3390/ijms242216373 -
Alternative Therapies in Health and... Nov 2023Acute radiodermatitis is a type of skin injury caused by tumor radiotherapy. Compound Dahuang Baiji spray (CDBS) is a traditional Chinese medicine spray made from...
Acute radiodermatitis is a type of skin injury caused by tumor radiotherapy. Compound Dahuang Baiji spray (CDBS) is a traditional Chinese medicine spray made from Dahuang and Baiji decoction. In the present study, we aimed to investigate the effects and mechanisms of CDBS on radiation dermatitis. We analyzed the main components of CDBS using High Performance Liquid Chromatography (HPLC). Through network pharmacology prediction, the target of Dahuang and Baiji was identified as arachidonate 5-lipoxygenase (ALOX5), associated with inflammation. Therefore, we constructed radiodermatitis rat models and treated them with CDBS for 14 d. Skin samples were collected from the rats' injured skin tissues, and pathological changes, oxidative stress indicators, inflammatory cytokines, and ALOX5 expression were detected using techniques such as HE staining, blood parameters analysis, ELISA, Real-time qPCR, and Western blot. The characteristic appearances of radiodermatitis were observed in different rat groups which indicated that the skin injury score in the model group was at grade II and was at grade I in the CDBS group. In addition, the HE results showed that CDBS reduced the necrosis of collagen fibers and inflammatory cell infiltration in the dermis of the radiodermatitis rats. Moreover, compared to the model group, CDBS significantly decreased leukocytes, lymphocytes, and neutrophils in the blood, as well as levels of IL-2, LTB4, 5-LO, NO, and ALOX5 expression in rat blood. Our findings suggest the therapeutic effect of CDBS on radiodermatitis by downregulating ALOX5 to inhibit inflammation, potentially serving as a radiodermatitis therapy.
PubMed: 37971445
DOI: No ID Found -
Nan Fang Yi Ke Da Xue Xue Bao = Journal... Oct 2023To observe the therapeutic effect of metformin on pathological pain in mice with radiation dermatitis and explore the underlying mechanism.
OBJECTIVE
To observe the therapeutic effect of metformin on pathological pain in mice with radiation dermatitis and explore the underlying mechanism.
METHODS
Thirty-two male adult ICR mice were randomized into normal control group, radiation dermatitis model group, metformin treatment (200 mg/kg) group and gabapentin (100 mg/kg) group (=8).In the latter two groups, metformin treatment was administered after modeling via intraperitoneal injection and gabapentin by gavage on a daily basis for 16 days; the mice in the control group and model group received intraperitoneal injection of normal saline.After the last administration, radiation dermatitis was graded in each group.Mechanical withdraw threshold (MWT) and thermal withdrawal latency (TWL) of the mice were tested one day before and at 1, 4, 8, 12 and 16 days after modeling.Western blotting was used to measure the protein expression levels of p38MAPK, p-p38MAPK, NF-κB p65 and p-NF-κB p65 in the L-L spinal cord, and the concentrations of IL-1β, IL-6 and TNF-α in the spinal cord tissue were determined with ELISA.
RESULTS
Compared with those in the control group, the mice in the other 3 groups showed obvious symptoms of radiation dermatitis after modeling (<0.05), which were significantly alleviated by treatment with metformin (<0.05).The mice in the model group exhibited significant decreases in MWT and TWL (<0.05), which were improved by treatment with metformin and gabapentin (<0.05).Compared with those in the model group, the levels of p-p38MAPK, p-NF-κB p65, IL-1β, IL-6 and TNF-α in the spinal cord were significantly decreased in the mice after metformin treatment (<0.05).
CONCLUSION
Metformin can significantly ameliorate pathological pain symptoms in mice with radiation dermatitis possibly by inhibiting the activation of p38MAPK/NF-κB signaling pathway.
Topics: Animals; Male; Mice; Gabapentin; Interleukin-6; MAP Kinase Signaling System; Mice, Inbred ICR; NF-kappa B; Pain; Tumor Necrosis Factor-alpha; Metformin; Radiation Injuries, Experimental; Radiodermatitis
PubMed: 37933660
DOI: 10.12122/j.issn.1673-4254.2023.10.22 -
In Vivo (Athens, Greece) 2023Radiation therapy (RT) for head and neck cancer may cause severe radiation dermatitis (RD) resulting in RT interruption and affecting disease control. A few studies...
BACKGROUND/AIM
Radiation therapy (RT) for head and neck cancer may cause severe radiation dermatitis (RD) resulting in RT interruption and affecting disease control. A few studies address skin moisture changes during RT for head and neck cancer. The purpose of this study was to explore the effect of moisturized skin care (MSC) on severity of RD.
PATIENTS AND METHODS
The study includes newly diagnosed head and neck cancer patients undergoing RT. Participants were divided into MSC group and routine skin care (RSC) group based on patient's preferred decision. Skin moisture in the four quadrants of the neck was measured weekly before and after RT. RD was assessed with the Radiation Induced Skin Reaction Assessment Scale (RISRAS) and the Radiation Therapy Oncology Group (RTOG) acute skin toxicity grading criteria.
RESULTS
A total of 54 patients were enrolled, of which 49 patients were suitable for the statistical analysis. There was a statistically significant difference in the RISRAS total score since the 5 week after RT between the groups. The severity of RD was less (B=0.814, p=0.021) and the onset was later (B=-0.384, p=0.006) in the MSC group when compared to the RSC group. Skin moisture decreased with cumulative radiation dose. In the upper neck, the MSC group had a slower rate of skin moisture decrease compared to the RSC group (right upper neck: B=0.935, p=0.007; left upper neck: B=0.93, p=0.018).
CONCLUSION
MSC can effectively reduce the severity and delay the onset of RD, while slows down skin moisture decrease during RT.
Topics: Humans; Radiodermatitis; Head and Neck Neoplasms; Skin Care
PubMed: 37905662
DOI: 10.21873/invivo.13389 -
In Vivo (Athens, Greece) 2023Adjuvant radiotherapy (RT) for breast cancer can be associated with acute dermatitis (ARD) and pneumonitis (RP). Prevalence and risk factors were characterized.
BACKGROUND/AIM
Adjuvant radiotherapy (RT) for breast cancer can be associated with acute dermatitis (ARD) and pneumonitis (RP). Prevalence and risk factors were characterized.
PATIENTS AND METHODS
This study included 489 breast cancer patients receiving adjuvant RT with conventional fractionation (CF) ± sequential or simultaneous integrated boost, or hypo-fractionation ± sequential boost. RT-regimen and 15 characteristics were investigated for grade ≥2 ARD and RP.
RESULTS
Prevalence of grade ≥2 ARD and RP was 25.3% and 2.5%, respectively. On univariate analyses, ARD was significantly associated with CF and radiation boost (p<0.0001), age ≤60 years (p=0.008), Ki-67 ≥15% (p=0.012), and systemic treatment (p=0.002). On multivariate analysis, RT-regimen (p<0.0001) and age (p=0.009) were associated with ARD. Chronic inflammatory disease was significantly associated with RP on univariate (p=0.007) and multivariate (p=0.016) analyses.
CONCLUSION
Risk factors for grade ≥2 ARD and RP were determined that may help identify patients who require closer monitoring during and after RT.
Topics: Humans; Middle Aged; Female; Breast Neoplasms; Radiation Pneumonitis; Radiodermatitis; Pneumonia; Dose Fractionation, Radiation; Lung Neoplasms
PubMed: 37905621
DOI: 10.21873/invivo.13374 -
Radiation Oncology (London, England) Oct 2023Randomized controlled study was conducted to evaluate the efficacy of Sanyrene® vs. control intervention (DaBao®, a complex of hyaluronic acid and Vitamin E) for acute... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Randomized controlled study was conducted to evaluate the efficacy of Sanyrene® vs. control intervention (DaBao®, a complex of hyaluronic acid and Vitamin E) for acute radiation dermatitis in patients receiving radiotherapy.
METHODS
Patients with breast cancer or head and neck cancer undergoing radiotherapy (≥ 50 Gy) were eligible. Participants were randomly assigned to either Sanyrene arm or control intervention arm in a ratio of 1:1. The primary endpoint was incidence rate of ≥ grade 2 radiation induced dermatitis. (Trial Registration: ChiCTR2100050910, registration date: 9/7/2021) RESULTS: A total of 102 eligible patients were randomly assigned into the study. The rate of ≥ grade 2 radiation dermatitis was 22% in Sanyrene group, as compared with 67.3% in the control intervention group (P<0.001). The incidence of grade 3 radiation dermatitis was 20.4% and 8.0% in control intervention group and Sanyrene group, respectively (P = 0.076). Patients in Sanyrene group had a longer median time to reach ≥ grade 2 radiation dermatitis compared to these in control intervention group, with hazard ratio of 0.231 (95%CI:0.116-0.458, p < 0.001). Mean score of SD-16 were much higher in control intervention group than Sanyrene group at end of radiotherapy (25 vs.8.3), 2 weeks after radiotherapy (22.9 vs. 0.5) and 4 weeks after radiotherapy (4.2 vs.0), with significantly statistical difference between two groups.
CONCLUSIONS
This trial suggests that Sanyrene is effective on preventing serious radiation dermatitis and improving skin related quality of life in patients with breast cancer or head and neck cancer receiving radiotherapy.
Topics: Humans; Female; Radiodermatitis; Quality of Life; Breast Neoplasms; Head and Neck Neoplasms
PubMed: 37891689
DOI: 10.1186/s13014-023-02363-9 -
PloS One 2023We applied a radiomics approach to skin surface images to objectively assess acute radiation dermatitis in patients undergoing radiotherapy for breast cancer.
PURPOSE
We applied a radiomics approach to skin surface images to objectively assess acute radiation dermatitis in patients undergoing radiotherapy for breast cancer.
METHODS
A prospective cohort study of 20 patients was conducted. Skin surface images in normal, polarized, and ultraviolet (UV) modes were acquired using a skin analysis device before starting radiotherapy ('Before RT'), approximately 7 days after the first treatment ('RT D7'), on 'RT D14', and approximately 10 days after the radiotherapy ended ('After RT D10'). Eighteen types of radiomic feature ratios were calculated based on the values acquired 'Before RT'. We measured skin doses in ipsilateral breasts using optically stimulated luminescent dosimeters on the first day of radiotherapy. Clinical evaluation of acute radiation dermatitis was performed using the Radiation Therapy Oncology Group scoring criteria on 'RT D14' and 'After RT D10'. Several statistical analysis methods were used in this study to test the performance of radiomic features as indicators of radiodermatitis evaluation.
RESULTS
As the skin was damaged by radiation, the energy for normal mode and sum variance for polarized and UV modes decreased significantly for ipsilateral breasts, whereas contralateral breasts exhibited a smaller decrease with statistical significance. The radiomic feature ratios at 'RT D7' had strong correlations to skin doses and those at 'RT D14' and 'after RT D10' with statistical significance.
CONCLUSIONS
The energy for normal mode and sum variance for polarized and UV modes demonstrated the potential to evaluate and predict acute radiation, which assists in its appropriate management.
Topics: Humans; Female; Radiodermatitis; Breast Neoplasms; Prospective Studies; Breast; Skin
PubMed: 37883380
DOI: 10.1371/journal.pone.0293071