Appendix 5: Summary of Evidence: RCT/Systematic reviews
++ = high quality study
+ = acceptable quality
0 = rejected, unacceptable quality
Author and
Year
Description
Butcher et
al 2012
Chan et al
2014
Scale or other
measuring
tool
n
Intervention
and control
Category of
patients
Systematic
review
10
N/A
Breast
Systematic
Review
47 RCTs
from
1962-2012
Trials of oral
All included
systemic
therapies
(n=6)
Washing
practices
(n=2)
Deodorant
use (n=4)
Topical
steroids
(n=5)
Non-steroidal
topical
therapies
(n=23)
Dressings
(n=6)
Light
emitting
Category
(primary
endpoint)
All
Results
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
P-value
QA
+
++
diode photomodulation
(n=1)
Abbas 2012
Non blinded
RCT single
centre
RTOG
30
Trolamine® vs.
standard of care
Head and
Neck
Grade 1-2
Grade 3
Watson et al Non blinded
2012
RCT single
centre
CTCAE
198
FACT-B QoL
questionnaire
Aluminium
based
antiperspirant
vs. standard of
care
Breast
Grade 3
80% (12/15)
treatment
group
46.6% (7/15)
control group
+
P<0.01
20%(3/15)
treatment
group
53.4%(8/15)
control group
4/99
treatment and
3/99 control
developed
toxicity
+
No statistical
difference
between
intervention
and control for
QoL
Haddad et al Non RCT RTOG
2013
Self-controlled
study
60
Aloe Vera
self-controlled.
Half treatment
Head and
Neck, Pelvis,
Breast
Grade 1-3 by
week 5
treatment half
Grade 1 n=42
Grade 2 n=3
+
(omitted
Q2, 3,and
field control,
other half
intervention
Herst et al
2014
Intra- patient
RCT - blinding
not possible
RTOG and
Modified
RISRAS
78
Mepitel® /film
vs. aqueous
cream
Jensen et al
2011
Single Centre
RCT
ONS
66
Kirova et al
2011
Phase III RCT
RTOG
VAS
EORTC
200
Grade 3 n=1
4 on RCT
SIGN )
Control half
Grade1 n= 32
Grade2 n=17
Grade3 n=1
Breast
Moist
desquamation
0%
intervention
26% control
P<0.001
+
WO1932 ( oil in
Breast
water emulsion )
vs. no treatment
ONS 0-3
visit 3 (day 47
+/- 7)
normalised
skin higher in
treatment
group n=14 vs.
control
n=6
P=0.059
+
Hyaluronic Acid
vs. control
emollient
Disappearance
of erythema
based
Colormetric
values
20.4% in
intervention
arm
13% in control
arm
failure =
interruption of
treatment
n=23 (24.2%)
in intervention
arm
n=32 (33.7%)
in control arm
Breast
+
P=0.46
p=0.15
Paterson et
al 2012
Within
subjects RCT,
no blinding
RISRAS
74
Mepilex®lite
dressings vs.
aqueous cream
Breast ( post
mastectomy)
RISRAS score
Results
showed
improved
average
RISRAS scores
for Mepilex
®lite
compared
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
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
Niazi et al
2012
Phase III RCT blinding not
possible
CTCAE version
4
44
(p<0.001)
0
+
P=0.18
1.3 + 0.8
control
2.53 (1.17 SD)
control group
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
scored by
clinicians
medial/lateral
applications
were
compared for
the two
products. In
the proportion
of cases with ≥
grade 3 skin
reaction, there
was a
significant
difference for
medial applied
creams 18%
(Sorbolene) vs.
28%
(moisturizing
double barrier
cream)
p=0.047.
Sharp et al
2013
Blinded RCT
411
Calendula
Weleda® cream
vs. Essex®
(Aqueous)
cream
Breast
Follow up
Ulff et al
2013
Double
Blinded RCT 3
arm
RTOG
EORTC QLQ
C30,
a visual
analogue
scale patient
experience
and
adherence
RTOG
Colorimeter
VAS
125
Betsmethasone
(steroid)
+Essex® cream
Breast
RTOG 0-1
ARSR (RTOG
p=0.55.
grade ≥2) was
23% in the
Calendula
group and 19%
in the
Aqueous
cream group
at follow up
22/53 B+E
7/49
P=0.001
moisturisers
+
++
++
DLQI
Zhong et al
2013
Single centre
RCT
RISRASS
88
(B+E)
vs.
Essex® cream
vs.
Canoderm®
cream
RTOG 3
Mepilex® lite
dressing vs.
normal skin care
(cleaning with
salted water)
Time to
wound healing
7/53 B+E
15/49
moisturisers
Nasopharynx
Mepilex®
median time
to wound
healing 16
days (95% CI
12-19)
Control
median time
to wound
healing 23days
(95% CI 19-27)
Lewis et al
2014
Single centre
RCT remote
randomisation
double
blinded
RTOG, HDSS
plus visual
scale
285
Three arms,
aluminium –
containing
deodorant plus
soap; noncontaining
aluminium
deodorant plus
soap and soap
only. Soap was
low irritant pH6
free from
fragrance,
colour and
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
0
p=0.009.
++
lanolin and
propylene
glycol.
group
compared
with the
control but
this was not
significant; pts
in the
aluminum deo
group
experienced
significantly
less sweating
than the
control group.
Conclusion:
use of
aluminium
deodorant did
not adversely
affect skin
reaction.
Diggelmann
et al 2010
systematic
inpatient
controlled
trial
RISRAS
N=24
Areas of
erythema were
divided in half
and randomly
assigned to have
either the
Mepilex lite
dressing or
aqueous cream
Breast
Included
severity of skin
reaction, dose
build up and
skin surface
temperature.
The primary
trial outcome
was dry
desquamation,
Mepilex lite
significantly
decreased the
extent or
radiation
induced skin
reactions
0
p <0.001