Topical Betamethasone Valerate As a Prophylactic Agent to Prevent Acute Radiation Dermatitis in Head and Neck Malignancies: A Randomized, Open-Label, Phase 3 Trial

Menon, Abhilash; Prem, Shyama Sudha; Kumari, Rashmi

doi:10.1016/j.ijrobp.2020.08.040

Cited by 15 publications

(19 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…One trial administered topical mometasone and the other five administered topical betamethasone. The follow‐up period was mentioned in all six studies 16,21–25 . Among them, three studies included patients who underwent concurrent chemotherapy 21–23 .…”

Section: Resultsmentioning

confidence: 99%

Efficacy of topical steroids in preventing radiation dermatitis: A systematic review and meta‐analysis

Shao

Chen

et al. 2022

Dermatologic Therapy

View full text Add to dashboard Cite

To evaluate the relative efficacy of topical steroids in preventing radiation dermatitis (RD). Multiple databases including Medline, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), China Biological Medicine (SinoMed), and Wanfang Database were searched for randomized controlled trials (RCTs) of RD prevention in patients with cancer from inception to November 26, 2021, followed by an update on June 1, 2021. Six RCTs evaluating the efficacy of topical steroids in preventing RD in a total of 661 patients with cancer were included.RD incidence was lower with topical steroids compared with placebo at week 3 (relative risk [RR] = 0.68, 95% confidence interval [CI]: 0.31-1.50) and at radiation therapy (RT) completion (RR = 0.97, 95% CI: 0.93-1.00). Topical steroids demonstrated a less risk of developing dermatitis of Radiation Therapy Oncology Group (RTOG) grades 2 and 3 at the completion of RT (RR = 0.66, 95% CI: 0.55-0.80 and RR = 0.54, 95% CI: 0.38-0.77, respectively). However, topical steroids did not reduce RTOG grades 1 and 2 dermatitis at week 3(RR = 0.73, 95% CI: 0.45-1.14 and RR = 0.66, 95% CI: 0.27-1.60, respectively). Notably, the use of topical steroids did not decrease RD incidence when patients received combined chemotherapy (RR = 0.60, 95% CI: 0.42-0.86), and an obvious reduction in the incidence of RD at RT completion was found when patients used the topical steroids twice-daily (RR = 0.66, 95% CI: 0.47-0.93, P = 0.02). Topical steroids reduced RD incidence in patients receiving RT. Thus, twice-daily topical steroids may be recommended for patients at the beginning of RT.

show abstract

Section: Resultsmentioning

confidence: 99%

Efficacy of topical steroids in preventing radiation dermatitis: A systematic review and meta‐analysis

Shao

Chen

et al. 2022

Dermatologic Therapy

View full text Add to dashboard Cite

show abstract

“…The results of the previous studies suggested that low dose of corticosteroids may be beneficial in reducing itching and irritation in patients with radiodermatitis. Moreover, steroids are contraindicated in the presence of infection as they could mask the signs and symptoms of infection and worsen it [16,18,45]. The first clues to the biological effect of β -adrenergic receptor in wound-healing process came from Donaldson study, revealing that β -adrenergic receptor agonists delay wound repairing in newt limbs [46].…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies evaluated the effect of various topical formulations in RID, such as aloe vera, anionic phospholipids and hyaluronic acid based formulation, and corticosteroids [16][17][18][19][20]. However, until now, there is no standard measure for prevention of RID in patients with breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Effects of topical timolol for the prevention of radiation-induced dermatitis in breast cancer: a pilot triple-blind, placebo-controlled trial

et al. 2022

View full text Add to dashboard Cite

Introduction Radiation therapy is one of the standard methods in the treatment of breast cancer. Radiotherapy-induced dermatitis (RID) is a common complication of radiotherapy (RT) resulting in less tolerance in RT and even discontinuation of treatment. Timolol is a β-adrenergic receptor antagonist that presents the best wound healing effects on both chronic and incurable wound healing. Topical forms of timolol could be effective in the prevention of RID due to the role of β-adrenergic receptors in skin cells and keratinocyte migration, as well as the anti-inflammatory effect of timolol. However, no placebo-controlled randomized trial is available to confirm its role. The current trial aimed to evaluate the efficacy of topical timolol 0.5% (w/w) on the RID severity and patients' quality of life (QOL). Method Patients aged older than 18 years with positive histology confirmed the diagnosis of invasive and localized breast cancer were included. Patients were randomized based on the random number table to receive each of the interventions of timolol 0.5% (w/w) or placebo topical gels from the first day of initiation of RT and for 6 weeks, a thin layer of gel twice daily. Patients were asked to use a thin layer of gel for at least two hours before and after radiation therapy. Primary outcomes were acute radiation dermatitis (ARD) grade using Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) scale and severity of desquamation based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Secondary outcomes were QOL based on Skindex16 (SD-16), maximum grade of ARD, and time of initial RD occurrence. Results A total of 64 female patients with an age range of 33 to 79 years were included. The means (SD) of age were 53.88 (11.02) and 54.88 (12.48) in the control and timolol groups, respectively. Considering the RTOG/EORTC and CTCAE scores the difference between groups was insignificant (P-Value = 0.182 and P-Value = 0.182, respectively). In addition, the mean (SD) of time of initial RID occurrence in placebo and timolol groups were 4.09 (0.588) and 4.53 (0.983) weeks, respectively (P-Value = 0.035). The maximum grade of RID over time was significantly lower in the timolol group. During the study period, 75.0% of patients in placebo groups had grade 2 of ARD while in the timolol group it was 31.3% (P-Value = 0.002). QoL was not significantly different between groups (P-Value = 0.148). Conclusion Although the topical formulation of timolol, 0.5% (w/w), was found to reduce the average maximum grade of ARD and increase the mean (SD) time of initial RID occurrence, it showed no effect on ARD, severity, and QOL. However, future clinical trials should be performed to assess timolol gel formulation in larger study populations. Trial registration https://irct.ir/ IRCT20190810044500N11 (17/03/2021).

show abstract

“…In a RCT by Menon et al topical betamethasone was compared with the institutional standard skincare in 121 HNC patients. 33% versus 51% of the patients developed grade 2 ARD and 20% versus 24% grade 3 ARD in the experimental and control arm, respectively [30]. These contrasting numbers on severe ARD are due to differences in the treatment protocol (e.g., total RT dose, use of concomitant therapies, the volume of the treated area) and the standard skincare used [6].…”

Section: Discussionmentioning

confidence: 99%

Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial)

Robijns

Lodewijckx

Bollen

et al. 2021

Radiotherapy and Oncology

View full text Add to dashboard Cite

Background and purpose: The purpose of this study was to investigate the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients. Materials and methods: A randomised, placebo-controlled trial (RCT) with 46 HNC patients who underwent radiotherapy (RT) with or without concomitant chemotherapy was set up (DERMISHEAD trial). Patients were randomised to receive PBM or placebo treatments from the first day of RT (2Â/week) alongside the institutional skincare. The severity of skin reactions was assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) and the Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS). Quality of life (QoL) was evaluated using the Skindex-16 questionnaire. Results: PBMT significantly reduced NCI-CTCAE grade 2-3 ARD with 49% at the end of RT. Conclusion:The results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology -radiotherapy practice.

show abstract

Topical Betamethasone Valerate As a Prophylactic Agent to Prevent Acute Radiation Dermatitis in Head and Neck Malignancies: A Randomized, Open-Label, Phase 3 Trial

Cited by 15 publications

References 16 publications

Efficacy of topical steroids in preventing radiation dermatitis: A systematic review and meta‐analysis

Efficacy of topical steroids in preventing radiation dermatitis: A systematic review and meta‐analysis

Effects of topical timolol for the prevention of radiation-induced dermatitis in breast cancer: a pilot triple-blind, placebo-controlled trial

Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial)

Contact Info

Product

Resources

About