Appendix 5: Summary of Evidence: RCT/Systematic reviews ++ = high quality study + = acceptable quality 0 = rejected, unacceptable quality Author and Year Description Scale or other measuring tool n Intervention and control Category of patients Category (primary endpoint) Results P-value QA Butcher et al 2012 Systematic review 10 N/A Breast All + Chan et al 2014 Systematic Review 47 RCTs from Trials of oral systemic therapies (n=6) Washing practices (n=2) Deodorant use (n=4) Topical steroids (n=5) topical therapies (n=23) Dressings (n=6) Light emitting diode All included Radiation Induced skin reaction 36/47 of included articles considered at high risk of bias 10/47 rated at unclear risk Allocation concealment only reported in 22/47 studies Blinding and attrition only adequately described 21/47 ++
(n=1) 2012 Non blinded RCT single centre RTOG 30 Trolamine® vs. standard of care Head and Neck Grade 1-2 Grade 3 80% (12/15) treatment group 46.6% (7/15) control group 20%(3/15) treatment 53.4%(8/15) control group P<0.01 + Watson et al 2012 Non blinded RCT single centre CTCAE FACT-B QoL questionnaire 198 Aluminium based antiperspirant vs. standard of care Breast Grade 3 4/99 treatment and 3/99 control developed toxicity No statistical difference between intervention and control for QoL + Haddad et al 2013 Non RCT - study RTOG 60 Aloe Vera self-controlled. Half treatment field control, other half intervention Head and Neck, Pelvis, Breast Grade 1-3 by week 5 treatment half Grade 1 n=42 Grade 2 n=3 Grade 3 n=1 Control half Grade1 n= 32 + (omitted Q2, 3,and 4 on RCT SIGN ) controlled
with aqueous cream although no significant difference was identified for MD rates. Miller et al 2011 Double blind RCT CTCAE version 3 Skindex-16 176 Mometasone Furoate (MMF) vs. placebo cream Breast CTCAE mean maximal grade and SD (range 0.0-3.0) 1.2 + .85 intervention 1.3 + 0.8 control P=0.18 + Niazi et al 2012 Phase III RCT - blinding not possible CTCAE version 4 44 Sliver Clear Nylon Dressing (SCND) vs. standard skin care Lower GI Skin toxicity on final fraction of radiotherapy. Mean dermatitis and SD scores 1.67 (1.2 SD) intervention group 2.53 (1.17 SD) control P= 0.1 ++ Graham et al 2013 Double blind RCT CTCAE version 3 Photographic audit 318 barrier cream containing acrylate terpolymer (ATP) vs. a 10% glycerine cream (Sorbolene) Breast (post mastectomy) peak and overall skin reactions using the CTCAE scoring tool (version 3.0) plus a photographic audit of skin scores to confirm reactions medial/lateral applications were compared for the two products. In the proportion of cases with ≥ grade 3 skin reaction, there was a significant p=0.047. +
scored by clinicians difference for medial applied creams 18% (Sorbolene) vs. 28% (moisturizing double barrier cream) Sharp et al 2013 Blinded RCT RTOG EORTC QLQ C30, a visual analogue scale patient experience and adherence 411 Calendula Weleda® cream vs. Essex® (Aqueous) cream Breast Follow up ARSR (RTOG grade ≥2) was 23% in the Calendula group and 19% in the Aqueous cream group at follow up p=0.55. ++ Ulff et al 2013 Double Blinded RCT 3 arm RTOG Colorimeter VAS DLQI 125 Betsmethasone (steroid) cream (B+E) vs. Essex® cream vs. Canoderm® cream Breast RTOG 0-1 RTOG 3 22/53 B+E 7/49 moisturisers 7/53 B+E 15/49 moisturisers P=0.001 ++ et al 2013 Single centre RCT RISRASS 88 Mepilex® lite dressing vs. normal skin care (cleaning with salted water) Nasopharynx Time to wound healing Mepilex® median time to wound healing 16 days (95% CI 12-19) 0
Control median time to wound healing 23days (95% CI 19-27) p=0.009. Lewis et al 2014 Single centre RCT remote randomisation double blinded RTOG, HDSS plus visual scale 285 Three arms, aluminium deodorant plus soap; non- containing aluminium deodorant plus soap and soap only. Soap was low irritant pH6 free from fragrance, colour and lanolin and propylene glycol. Breast RTOG grade ≥2 score There was no association between deodorant use and RTOG score. The change in itching, pain or burning in the axilla was 0.02cm higher in the aluminium deo group compared with the control but this was not significant; pts in the aluminum deo group experienced significantly less sweating than the ++