MANAGEMENT OF ACUTE RADIATION-INDUCED SKIN DERMATITIS WITH CAMWELL™ HERB-TO-SOOTHE CREAM IN HEAD AND NECK CANCER PATIENTS RECEIVING RADIOTHERAPY - A SINGLE INSTITUTION PILOT OBSERVATIONAL STUDY -

E Cecil MS, CRNP; Z Cheng MD, MPH; P Han MD, MHS; B R Page MD; A P Kiess MD, PhD; H Quon MD,; The Johns Hopkins University

Purpose

Acute Radiation-Induced Skin Dermatitis (RISD) is a dose-dependent skin reaction that is experienced in 95% of patients who receive Radiation Therapy (RT). Due to the associated pain, pruritus, cosmetic changes, resource-intensive symptom management and risk of late-fibrosis, patient outcomes are often negatively impacted.

Background

There is currently no standard agent for the prevention or management of RISD in RT patients. We sought to explore whether Camwell™ Herb-to-Soothe Cream (Camwell), an aqueous based botanical compound, demonstrates efficacy in the prevention and/or management of RISD.

Materials & Methods

As part of our routine practice in a Head and Neck Cancer (HNC) clinic, patients complete a patient reported outcome questionnaire titled Skindex-16© (Skindex) at weekly office visits, captured digitally on a secure web-browser to our departmental analytic database (Oncospace) approved for use through an institutional IRB- approved prospective registry protocol. A digital Visual Analogue Scale (VAS) was available to assess RISD-associated pain, and the Common Terminology Criteria for Adverse Events (CTCAE) grading was available to document severity of RISD by clinician. Both of these scales are routinely used during weekly office visits as well.

The Skindex is validated to measure the effects of skin disease on patient bother and Quality of Life (QoL), with a higher Skindex score correlating to worse patient skin disease and poorer QoL.
The primary eligibility criteria for this analysis were 1) HNC patients treated with radiotherapy with curative intent who 2) completed the Skindex on a secure web- browser 3) during weekly office visits with 4) missing no more than 25% of questions.

Patients were retrospectively categorized into one of the following three management groups for analysis: “prophylactic” – patient self-reported starting use of Camwell in the first week of treatment, “therapeutic” – patient self-reported starting use of Camwell after the first week of treatment, or “Standard of Care” (SoC) – patient self-reported use of other skin agent or did not use any skin agent throughout treatment. A non-parametric Krustal-Wallis test was used to compare the Mean Total Skindex Score (MTS) for each of the three management groups, as the primary objective measure

Results

A total of 112 patients met the criteria for analysis, with prophylactic N=42, therapeutic N=15, and SoC N=55. The duration of used for the analysis ranged from 11/2017 – 7/2018. The median age was 62. 55 (48.75%) patients had HPV-associated carcinoma, 57 (50.4%) underwent pre-RT surgery, and 68 (60.7%) underwent concurrent chemotherapy.

The MTS of the prophylactic, SoC and therapeutic groups of patients was 7.2, 13.3 and 8.6 respectively (p = 0.067). The mean VAS skin pain score of the prophylactic, SoC and therapeutic groups of patients was 0.7, 1.0 and 1.0 respectively (p = 0.29). Analysis of weekly data demonstrated the MTS and VAS increased earlier during the RT in the SoC and therapeutic groups than it did in the prophylactic group. Analysis of maximum CTCAE score demonstrated the majority of patients in the prophylactic group (48%) experienced grade 1 RISD, while the majority of patients in the therapeutic (33%) and SoC (56%) group experienced Grade 2 RISD (p = 0.009).

Discussion

Our pilot data demonstrates that, when analyzed as a function of time through six weeks of HNC treatment, Camwell was more efficacious than SoC or therapeutic intervention at minimizing RISD-bother as measured by the Skindex. Our data also suggests that patients may feel the effect of RISD prior to clinician visualization as would be assessed and measured with the CTCAE scale, and this needs be further explored through objective measurement.

Additionally, the therapeutic group started Camwell at various time points throughout treatment, with various degrees of RISD and Skindex scores initially. The effect of Camwell as a therapeutic rather than prophylactic agent, needs to be further explored.

Conclusions

Though our data did not demonstrate statistical significance (p = 0.067), our pilot observational study demonstrates that Camwell may be an efficacious agent for management of RISD, warranting further investigation.