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## Complete Summary

#### GUIDELINE TITLE

The prevention and management of acute skin reactions related to
radiation therapy.

#### BIBLIOGRAPHIC SOURCE(S)

Supportive Care Guidelines Group. Bolderston A, Lloyd NS, Wong RK,
Holden L, Robb-Blenderman L. The prevention and management of acute skin
reactions related to radiation therapy \[full report\]. Toronto (ON):
Cancer Care Ontario (CCO); 2005 Feb 21. 34 p. (Practice guideline
report; no. 13-7). \[46 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Cancers requiring radiation therapy

-   Acute skin reactions related to radiation therapy

#### GUIDELINE CATEGORY

Management\
Prevention\
Treatment

#### CLINICAL SPECIALTY

Oncology\
Radiation Oncology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

-   To evaluate the optimal methods to prevent acute skin reactions
    (occurring within the first six months of irradiation) related to
    radiation therapy

-   To evaluate the optimal methods to manage acute skin reactions
    related to radiation therapy

#### TARGET POPULATION

Adult patients with cancer of any histology who are undergoing radiation
therapy

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Prevention of Acute Skin Reaction**

1.  Washing practices

2.  Calendula ointment

3.  Plain, non-scented, lanolin-free hydrophilic cream

Notes:

-   Guideline developers recommended against limiting personal hygiene
    practices.

-   Guideline developers found insufficient evidence to support or
    refute other specific topical agents (i.e., corticosteroids,
    sucralfate cream, Biafine, ascorbic acid, aloe vera, chamomile
    cream, almond ointment, polymer adhesive skin sealant) for the
    prevention of acute skin reactions

-   Guideline developers found insufficient evidence to support or
    refute specific oral agents (i.e., enzymes, sucralfate) or
    intravenous agents (i.e., amifostine) for the prevention of acute
    skin reaction

**Management of Acute Skin Reaction**

Low-dose (i.e., 1%) corticosteroid cream

**Note**: Guideline developers found insufficient evidence to support or
refute topical agents, such as corticosteroids, sucralfate cream, or
specific dressings for the management of acute skin reactions.

#### MAJOR OUTCOMES CONSIDERED

-   Acute skin reaction

-   Pain

-   Itching

-   Burning

-   Quality of life

-   Adverse events

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A search of PreMEDLINE, MEDLINE, CANCERLIT, and the Cochrane Library
(2004, Issue 1) was conducted to identify comparative studies published
between 1980 and April 2004. Relevant articles were identified by
combining terms and phrases related to skin and specific skin conditions
with radiation therapy terms and combining these terms with terms
specific to study design. The Medical Subject Heading (MeSH) terms
\"dermis,\" \"epidermis,\" and \"skin/re\" (radiation effects) and text
words and phrases \"erythema,\" \"radiation dermatitis,\"
\"radiodermatitis,\" \"desquamation\" (dry and moist), and \"acute skin
reaction\" were combined with search terms for radiation therapy
including \"explode radiotherapy,\" \"radiotherapy/ae\" (adverse
effects) and a text word search for \"radiotherapy\" or \"radiation
therapy.\" These terms were then combined with the search terms for the
following publication types: practice guidelines, systematic reviews,
meta-analyses, reviews, randomized controlled trials, controlled
clinical trials, and comparative studies.

In addition, conference proceedings of the meetings of the American
Society of Clinical Oncology (ASCO) were searched for abstract reports
published between 1997 and 2003. The Canadian Medical Association
Infobase (<http://www.mdm.ca/cpgsnew/cpgs/index.asp>) and the National
Guidelines Clearinghouse (<http://www.guideline.gov/>) were also
searched for existing evidence-based practice guidelines. Relevant
articles and abstracts were selected and reviewed by two reviewers, and
the reference lists from these sources were searched for additional
trials, as were the reference lists from relevant review articles.

**Inclusion Criteria**

Articles were selected for inclusion if they met all of the following
criteria:

1.  They were systematic reviews, meta-analyses, evidence-based practice
    guidelines, or comparative studies comparing skin care practices
    administered by any route for the prevention or treatment of acute
    skin reactions due to radiation therapy.

2.  Data were collected prospectively in at least one arm of the trial.
    Historical controls were permitted.

3.  Clinically relevant outcomes to skin reaction were reported. The
    trial reported degree of skin reaction (using a validated skin
    reaction score) as an outcome. Other outcomes of interest included
    pain, itchiness, burning, quality of life, and toxicities.

4.  The article was a fully published or abstract report.

**Exclusion Criteria**

The following articles were excluded from this systematic review of the
evidence:

1.  Letters, comments, and editorials

2.  Articles published in a language other than English

#### NUMBER OF SOURCE DOCUMENTS

Twenty-eight trials were identified

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The primary outcome of interest for this review was the degree of skin
reaction. Secondary outcomes of interest included symptoms such as pain,
itchiness, burning, quality of life, and toxicities. Meta-analysis was
not performed because the included trials were too clinically
heterogeneous, mainly since they evaluated different treatment regimens.
For some interventions, only one trial was identified, thereby
eliminating the possibility of pooling. In addition, most trials were
too heterogeneous in terms of outcome assessment and reporting of
results.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

During the initial discussion of this guideline topic, the Supportive
Care Guidelines Group (SCGG) agreed that the evidence should be
separated into trials aimed at the prevention of acute radiation skin
reactions and those aimed at the management of acute radiation skin
reactions. The first draft of the practice guideline report was
circulated to the SCGG in March 2004. Overall, the SCGG approved the
draft guideline with some suggestions for clarification that were
subsequently incorporated in the draft sent out for external review. A
suggestion was made that more information on specific dressings for
wound management be provided in the Interpretive Summary section;
however, the authors felt this to be beyond the scope of this guideline
report. A companion document on wound management will be considered as a
future topic.

Feedback from the non-physician health care professional members of the
SCGG suggested that a statement on the definition of \"evidence-based\"
might provide some clarity. A nursing representative of the group
commented that since the evidence does not lend itself to definitive
recommendations for the majority of the interventions assessed, it might
be worthwhile producing a document on \"best practice.\" The authors
considered this comment in the context of two types of documents
produced by the Program in Evidence-based Care (PEBC), clinical practice
guidelines and evidence summaries, and felt it was important to
delineate the two and explain how these differ from the Registered
Nurses Association of Ontario\'s (RNAO) \"Best Practice Guidelines.\"

The PEBC\'s clinical practice guidelines and evidence summaries are
based on a systematic review of the best available research evidence,
with the practice guidelines consisting primarily of mature randomized
trials that contribute to the development of recommendations. When
insufficient evidence precludes the development of definitive
recommendations, an evidence summary is produced, offering opinions of
the SCGG until more mature research evidence on which to base
recommendations becomes available. Of importance is the fact that the
PEBC approach places great emphasis on the evidence base, and the SCGG,
a multidisciplinary guideline panel, interprets this evidence to provide
recommendations. The evidence source for our documents differs from that
of the Registered Nurses Association of Ontario, which, in addition to
using research evidence, also considers evidence from expert committee
reports, expert opinions, clinical experience, or expert authorities.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Practitioner feedback was obtained through a mailed survey of 264
practitioners and health care professionals in Ontario (86 radiation
oncologists, 146 oncology nurses, and 32, radiation therapists). The
survey consisted of items evaluating the methods, results, and
interpretive summary used to inform the draft recommendations and
whether the draft recommendations above should be approved as a practice
guideline. Written comments were invited. The practitioner feedback
survey was mailed out on April 15, 2004. Follow-up reminders were sent
at two weeks (post card) and four weeks (complete package mailed again).
The Supportive Care Guidelines Group (SCGG) reviewed the results of the
survey.

The practice guideline report was circulated to 15 members of the
Practice Guidelines Coordinating Committee (PGCC) for review and
approval. Ten of fifteen members of the PGCC returned ballots. Six PGCC
members approved the practice guideline report as written, one member
approved the guideline and provided suggestions for consideration by the
SCGG, and three members of the PGCC were also members of the SCGG and
were therefore not eligible to review the report.

Final approval of the guideline report is obtained from the Practice
Guidelines Coordinating Committee.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Prevention of Acute Skin Reaction**

-   Skin washing should not be restricted in patients receiving
    radiation therapy. Recommended washing practices include gentle
    washing^1^ with water alone or gentle washing with mild^2^ soap and
    water.

-   Patients receiving radiation therapy to the head should be advised
    to follow gentle washing practices with mild shampoo.

-   Limiting personal hygiene practices is not recommended as this may
    lead to psychosocial distress for the patient.

-   Limited evidence suggests that calendula ointment may decrease the
    occurrence of [\>]{.underline}Grade 2 radiation dermatitis in breast
    cancer patients. Its application in other types of cancer is unknown
    at this time.

-   There is insufficient evidence to support or refute other specific
    topical agents (i.e., corticosteroids, sucralfate cream, Biafine,
    ascorbic acid, aloe vera, chamomile cream, almond ointment, polymer
    adhesive skin sealant) for the prevention of acute skin reaction.

-   There is insufficient evidence to support or refute specific oral
    agents (i.e., enzymes, sucralfate) or intravenous agents (i.e.,
    amifostine) for the prevention of acute skin reaction. The side
    effects of these agents were more oppressive than those reported in
    the trials assessing topical agents, and therefore the benefits do
    not outweigh the risks.

**Management of Acute Skin Reaction**

-   There is insufficient evidence to support or refute topical agents
    such as corticosteroids, sucralfate cream, or specific dressings for
    the management of acute skin reaction.

**Opinions of the Supportive Care Guidelines Group**

-   In the opinion of the Supportive Care Guidelines Group, clinical
    experience suggests that initial use of a plain, non-scented,
    lanolin-free hydrophilic cream is helpful in preventing radiation
    skin reactions. This type of cream attracts and traps moisture at
    the skin surface to increase the skin\'s moisture and maintain skin
    pliability. The cream should be discontinued when skin breakdown
    occurs.

-   In the opinion of the Supportive Care Guidelines Group, clinical
    experience suggests that low-dose (i.e., 1%) corticosteroid cream
    may be beneficial in the reduction of itching and irritation. There
    does appear to be an inflammatory process associated with
    radiation-induced erythema that may be alleviated somewhat by
    corticosteroid creams. More evidence is needed to support firm
    recommendations.

^1^ \"Gentle washing\" involves using lukewarm water and taking care not
to scrub the skin. Showers should also be lukewarm and low-pressure.\
^2^ \"Mild soap\" is defined as a pH-balanced, non-scented product that
does not contain lanolin. There is no evidence to suggest that one type
of mild soap is preferable to another. However, in one study that rated
the irritant quality of 18 soaps, \"Dove\" was the only soap classified
as mild and may therefore be considered.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by practice guidelines, randomized,
and non-randomized trials.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Reduction in incidence and severity of skin reactions related to
radiation therapy

#### POTENTIAL HARMS

Adverse events were generally mild to moderate for those trials that
assessed topical agents. The most common treatment-related toxicities
were allergic reaction to the topical agent, itching, burning, and moist
desquamation. Overall, there were no significant differences in adverse
events between treatment groups for those trials evaluating topical
agents, aside from one trial that reported significantly less pain in
the aqueous cream group compared to patients in the aloe vera cream
group. Allergic reaction was the most commonly reported adverse reaction
in the aloe vera trials.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   Given the evidence for skin washing, it would seem likely that the
    same recommendations would follow for hair washing with shampoo for
    patients receiving radiation therapy to the head, but there is
    limited evidence to support this.

-   Only one trial compared calendula ointment to Biafine cream. The
    promising results of this large trial (n=254) in breast cancer
    patients suggest that calendula ointment may be beneficial to cancer
    patients undergoing radiation therapy. However, administration
    difficulties may lead to treatment discontinuation for some
    patients. No trial compared calendula to no treatment or placebo. It
    is currently unclear if calendula is superior to placebo or no
    treatment or whether these results can be generalized to cancer
    patients undergoing radiation therapy for other types of
    malignancies.

-   Caution must be used to avoid the overuse of corticosteroid cream;
    however, there is limited evidence to suggest that skin thinning
    would pose a problem for normal corticosteroid use during an average
    course of treatment (up to eight weeks). The practitioner must also
    be aware of potential patient allergies to topical corticosteroids
    and discontinue use if an allergic reaction occurs.

-   Care has been taken in the preparation of the information contained
    in this document. Nonetheless, any person seeking to apply or
    consult these guidelines is expected to use independent medical
    judgment in the context of individual clinical circumstances or seek
    out the supervision of a qualified clinician. Cancer Care Ontario
    makes no representation or warranties of any kind whatsoever
    regarding their content or use or application and disclaims any
    responsibility for their application or use in any way.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Safety

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Supportive Care Guidelines Group. Bolderston A, Lloyd NS, Wong RK,
Holden L, Robb-Blenderman L. The prevention and management of acute skin
reactions related to radiation therapy \[full report\]. Toronto (ON):
Cancer Care Ontario (CCO); 2005 Feb 21. 34 p. (Practice guideline
report; no. 13-7). \[46 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2005 Feb 21

#### GUIDELINE DEVELOPER(S)

Program in Evidence-based Care - State/Local Government Agency
\[Non-U.S.\]

#### GUIDELINE DEVELOPER COMMENT

The Practice Guidelines Initiative (PGI) is the main project of the
Program in Evidence-based Care (PEBC), a Province of Ontario initiative
sponsored by Cancer Care Ontario and the Ontario Ministry of Health and
Long-Term Care.

#### SOURCE(S) OF FUNDING

Cancer Care Ontario\
Ontario Ministry of Health and Long-Term Care

#### GUIDELINE COMMITTEE

Provincial Supportive Care Guidelines Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

For a current list of past and present members, please see the [Cancer
Care Ontario Web
site](http://www.cancercare.on.ca/english/toolbox/qualityguidelines/clin-program/supportive-care-ebs/supportive-care-gdg/).

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Members of the Supportive Care Guidelines Group (SCGG) disclosed
potential conflict of interest information and no conflicts were
declared.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[Cancer Care Ontario Web
site](http://www.cancercare.on.ca/pdf/pebc13-7f.pdf).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   The prevention and management of acute skin reactions related to
    radiation therapy. Summary. Toronto (ON): Cancer Care Ontario (CCO).
    Electronic copies: Available in Portable Document Format (PDF) from
    the [Cancer Care Ontario Web
    site](http://www.cancercare.on.ca/pdf/pebc13-7s.pdf).

-   Browman GP, Levine MN, Mohide EA, Hayward RSA, Pritchard KI, Gafni
    A, et al. The practice guidelines development cycle: a conceptual
    tool for practice guidelines development and implementation. J Clin
    Oncol 1995;13(2):502-12.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on May 2, 2005. The information was
verified by the guideline developer on May 6, 2005.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. Please refer to the
[Copyright and Disclaimer
Statements](http://www.cancercare.on.ca/ontariocancernews/copyright.html)
posted at the Program in Evidence-Based Care section of the Cancer Care
Ontario Web site.

### DISCLAIMER

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Date Modified: 11/3/2008