Pa rsi

nu

rt ng
of p
th rog
e ra
of m
fic m
Oral Mucositis

ia e
lE 2
BM 00
T 6
Assessment
Workshop Led by members of the EBMT
Mucositis Advisory Committee
based on the POMA audit
14.00–15.30, Monday 20 March 2006
Hall 6, CHH-Congress Center
Hamburg, Germany

W O R K B O O K
Oral Mucositis Assessment Workshop
Led by members of the EBMT Mucositis Advisory Committee based on
the POMA audit†

Chair: Barry Quinn (UK)

14.00 Introduction Barry Quinn

14.05 The burden of mucositis and the Barry Quinn

development of the POMA

14.10 Conducting an oral assessment Ann Roosaar (Sweden)

14.30 Oral mucositis assessment Becky Stone (UK)

interactive workshop

14.55 Providing optimal training Becky Stone

Mary Uhlenhopp (Amgen)

15.05 Future directions in the management Nicole Blijlevens

of oral mucositis (The Netherlands)

15.20 Discussion and Q&A session Barry Quinn

15.30 Close

The Prospective Oral Mucositis Audit is a joint project between EBMT nurses and physicians and Amgen Oncology
†
Dear Colleagues

It gives me great pleasure to welcome you to the ‘Oral Mucositis Assessment

Workshop’, which forms a part of the official EBMT nursing programme for 2006.

Oral mucositis (OM) is a common and debilitating side effect of chemotherapy that can
severely affect patient outcomes and quality of life and is associated with a substantial
financial burden. Historically, however, there has been a lack of standardized
assessment tools with which to diagnose and monitor OM. The pan-European
Prospective Oral Mucositis Audit (POMA) was undertaken, as a unique collaborative
venture involving nurses, physicians and dentists, to document the incidence, severity
and impact of OM in patients with haematological malignancies undergoing
haematopoietic stem cell transplantation.

This practical and interactive workshop will draw on the experiences of the POMA in
which participating healthcare professionals were trained in the assessment of OM to
enable them to record its incidence and severity more accurately. Members of the
EBMT Mucositis Advisory Committee will offer training in OM assessment and training
techniques will also be discussed. Furthermore, training materials will be provided to
assist you and your colleagues when you return to your centres. To conclude, strategies
for the management of OM will be presented to help minimize the severity and impact of
this condition in your patients and there will be an opportunity for you to address your
questions to the faculty.

We hope that you will find this workshop useful and stimulating and that it will provide
you with practical solutions for the assessment and management of OM.

Barry Quinn
On behalf of the EBMT Mucositis Advisory Committee

1
The burden of mucositis and the
development of the POMA
Barry Quinn (UK)
Barry Quinn, the current President of the EBMT Nurses’ Group, is a Lecturer
and Clinical Practitioner in haemato-oncology at the Royal Marsden, London,
UK. Barry organizes and delivers post-registration courses in cancer care,
haemato-oncology and transplantation and national study days covering these
and other issues including sexuality, spirituality and ethics. He is a Nurse
Representative on the Joint Accreditation Committee EBMT-ISCT Europe
(JACIE) Board and, as a member of the Mucositis Advisory Group, is involved
in the Prospective Oral Mucositis Audit. Barry currently chairs an expert panel
of European nurses, physicians and dentists looking at oral assessment tools in
the transplant and cancer setting. His special interests are symptom control,
quality of life issues in the transplant and cancer care setting and supporting
nurses and allied healthcare professionals to address these issues.

Damage to the mucosa of the alimentary tract, particularly the mouth, is a common complication of
chemotherapy.1 Severe oral mucositis (OM) is frequently seen in patients undergoing haematological
transplantation and receiving high-dose chemotherapy.2 Severe OM is associated with substantial
increases in patients’ requirements for opioid analgesics, hospitalization and total parenteral nutrition
and increased risks of infection;3,4 the risk of serious clinical consequences increases with each
worsening grade of OM.5 Patients rank OM as one of the most debilitating side effects of
myeloablative treatments for malignancies.4 However, data on the incidence and duration of OM are
incomplete and accurate evaluation is complicated by inconsistency in the performance of oral
assessments.3 The Prospective Oral Mucositis Audit (POMA) is a non-interventional audit of
approximately 200 European patients with haematological malignancies receiving conditioning
chemotherapy and autologous transplantation. The POMA was initiated to assess the incidence and
duration of severe OM in patients with haematological malignancies receiving treatments associated
with a high risk of OM. The following data were collected and recorded daily: oral assessment of
patients’ levels of pain, taste changes, nutrition, dysphagia, salivary production, presence/absence of
bleeding, scalloping, ulceration, erythema; temperature; and prophylaxis/treatments for mucositis.
Accurate evaluation of OM severity is fundamental to the accuracy of the audit’s findings. Developed
by the EBMT Mucositis Advisory Group, the POMA uses a multidisciplinary approach to ensure
consistency in assessments performed at participating centres. Studies suggest that greater
experience and training in conducting oral assessments is associated with a higher degree of
accuracy. The POMA represents a unique and successful collaboration between nurses, physicians
and dentists and it is hoped that it will encourage further multidisciplinary studies.
1. Robien K et al. J Clin Oncol 2004;22:1268–75 3. Sonis ST et al. Cancer 2004;100(suppl 10):1995–2025
2. Shea TC et al. Biol Bone Marrow Transplant 4. Bellm L et al. Support Care Cancer 2000;8:33–9
2003;9:443–52 5. Harousseau J-L et al. EBMT 2005;(Abstr & poster)
2
Key slides

Oral mucositis confers a risk of serious

clinical consequences
• Severe OM is associated with serious clinical consequences
that increase with each worsening grade of OM
Total parenteral
nutrition
Injectable
narcotic therapy

Hospitalization

Infection

0 1 2 3 4 5
Additional days
Harousseau J-L et al. EBMT 2005;(Abstr & poster)

True incidence of oral mucositis is unknown

• Most OM incidence rates reflect AE reports from studies

where OM reporting was only a secondary objective1
– Methods not consistent or standardized
– Differences in frequency, quality and grading of
OM assessments
• There are few well-designed, randomized trials for OM
interventions and OM is under-reported2,3

1. Sonis ST et al. Cancer 2004;100(Suppl. 10):1995–2025

2. Clarkson J et al. The Cochrane Library. 2004;1. Chichester, UK: John Wiley & Sons, Ltd
3. MASCC Clinical Practice Guidelines: Rubenstein EB et al.
Cancer 2004;100(Suppl.):2026–46 AE, adverse event

POMA study design

• Prospective, non-interventional audit of ~200 patients with

MM / NHL receiving HD melphalan or BEAM with autologous
HSCT in 25 European centres
• Daily OM assessment by specially trained assessors from
start of conditioning CT to hospital discharge or Day 30 using
WHO scale for:
– Severity of OM
– Duration of hospitalization
– Additional treatments (opioids, TPN, antibiotics etc)
– Temperature
MM, multiple myeloma; NHL, non-Hodgkin’s lymphoma;
HD, high dose; BEAM, carmustine, etoposide, cytarabine, melphalan;
CT, chemotherapy; TPN, total parenteral nutrition

3
Conducting an oral assessment
Ann Roosaar (Sweden)
Ann Roosaar is a Doctor of Dental Surgery based at the Karolinska Institute’s
Institute of Odontology in Huddinge, Stockholm, Sweden. Ann also teaches
at the Dental School in Stockholm. Since 1993, Ann has worked as a hospital
dentist in close collaboration with the Haematology Department at
Huddinge Hospital. Ann’s special interests include oral care for patients
undergoing cancer treatment. Her particular area of research is oral mucosal
lesions and cancer incidence and mortality over a 30-year period. Ann is the
co-author of a Swedish publication entitled ‘Oral care in cancer treatment’.

Many scales are available for assessing the severity of oral mucositis (OM), of which the World
Health Organization (WHO)1 scale is commonly used. This scale is based on subjective,
objective and functional outcomes and assesses the impact of OM on the patient.1

Oral assessments should be performed daily in order to monitor changes in the patient’s
condition. Performing an oral assessment using the WHO scale involves recording patient-
reported outcomes, including an assessment of the patient’s ability to eat – a critical driver of
the scale. It is important to determine whether an inability to eat is due to OM or other causes.
The recording of patient-reported outcomes should include an evaluation of their degree of
mouth pain/discomfort, mucosal dryness and difficulty swallowing and tasting food. The
patient’s mouth should also be assessed for bleeding, scalloping and saliva production.

The clinical examination should represent the last stage of the assessment so that manipulation
of the mouth does not affect patient-reported outcomes. The examination should be
performed with appropriate infection control and good lighting. It should take only a few
minutes to complete; the more frequently it is performed, the more quickly and accurately the
assessor can complete the assessment. During an oral assessment, eight oral sites should be
evaluated for ulceration/pseudomembrane formation and erythema. The results obtained
during the assessment of these eight sites allow the assessor to assign a mucositis score
based on the WHO scale.

1. World Health Organization. Handbook for reporting results of cancer treatment 1979;pp15–22

4
Key slides

Assessment sequence

Conduct the assessment in the following order:

1. Introduce yourself to the patient and explain what you are doing
2. Record the patient’s temperature
3. Evaluate patient-reported outcomes in relation to OM:
• Nutrition: ability to eat based on the extent of OM
• Discomfort: degree of mouth pain, mucosal dryness,
difficulty swallowing, taste function
4. Assess the patient’s mouth for bleeding, scalloping and
saliva production
5. Assess the eight oral sites for ulceration and erythema
6. Assign a WHO score and thank the patient for their cooperation

Oral sites to be evaluated

Upper inside lip

Soft palate

Left inside cheek

Right inside cheek

Left lateral and

ventral tongue
Right lateral and
ventral tongue

Floor of mouth

Lower inside lip

Summary

• Oral assessments should be performed daily, starting from

baseline (before onset of OM)
• Patient-reported outcomes are important, including
assessment of the patient’s ability to eat
• Clinical evaluation of the eight oral sites should represent the
final stage of the assessment
• With practice, oral assessments can be performed accurately
in only a few minutes

5
Oral mucositis assessment
interactive workshop
Becky Stone (UK)
Becky Stone is a Consultant Nurse in Clinical Haematology based in the
transplant unit at Nottingham City Hospital, UK. Becky carried out her
training to become a specialist oncology nurse at the Royal Marsden, London,
UK, and during this time she became involved in bone marrow
transplantation (BMT). Her current role in the expanding transplant unit at
Nottingham encompasses four areas: clinical practice, research, leadership
and education. Becky is the Chair of the EBMT nursing research group and
she is a member of the committee of the Royal College of Nursing
Haematology and BMT forum – a national group that advises and supports
the nursing care of haematological patients undergoing BMT. Her area of
special interest is life after transplant and rehabilitation of this patient group.

The key drivers of the World Health Organization (WHO) oral mucositis (OM) scale combine subjective,
objective and functional outcomes: the presence/absence of pain; erythema and ulceration; and the
ability to swallow liquids/solids.1 Assessing the oral cavity is complicated by the inconsistent
appearance of the oral mucosa between individuals, although time and experience can improve the
accuracy of evaluations. It is important to consistently assess and record findings rather than try to
make a diagnosis. If possible, assessments should be conducted at the same time each day.

Assessors should bear in mind the key features of the WHO scale:1
• Grade 0: no objective findings
• Grade 1: soreness plus erythema
• Grade 2: ulceration and ability to eat solids
• Grade 3: ulceration and cannot swallow solid diet
• Grade 4: ulceration and alimentation not possible due to OM
(does not include ability to take oral drugs)

Ability to eat liquid or solid foods and the presence of ulcers are, therefore, key drivers of the
scale although the extent of ulceration is not a driver because ability to eat with ulcers varies
considerably between patients. Erythema is also not a driver as this is very difficult to assess
consistently. Assessors should ensure that documented changes in patients’ levels of pain and
ability to eat solid or liquid foods are based on their OM rather than other related causes, such
as nausea. If an assessor is unsure of grading, caution should be used and a higher rather than
a lower grade should be assigned. This interactive session will discuss the grading of OM
according to the WHO scale using example patient cases.

1. World Health Organization. Handbook for reporting results of cancer treatment 1979;pp15–22

6
Key slides

Oral mucositis is associated with serious

clinical consequences

Clinical consequences worsen with increasing

severity of oral mucositis
p<0.009 Grade 0–1 OM
p<0.005 Grade 2 OM
100 p<0.001 94 Grade 3–4 OM

80 76
71
Patients (%)

60
46 46 43
40
40 30
20
20

0
Opioid use TPN FN
Harousseau J-L et al. EBMT 2005;(Abstr & poster) TPN, total parenteral nutrition;
FN, febrile neutropenia

Multiple scales are used for assessing

oral mucositis1
Oral mucositis Other
assessment 11%
scale (OMAS)
Oral 4%
assessment WHO scale*
guide (OAG) 74%
4%

Self-developed
standards Base n=27
7%

*The WHO scale is the most widely

1. Stone R et al. EBMT 2005;(Abstr. N920)
2. World Health Organization. Handbook for reporting
results of cancer treatment 1979;pp15–22
recognized scale for assessing oral
mucositis and is based on subjective,
objective and functional outcomes2
WHO, World Health Organization

WHO scale for assessment of oral mucositis

Cut-off for ulcerative Cut-off for severe

oral mucositis oral mucositis

Scale 0 1 2 3 4

WHO oral None Soreness Ulcers +/- Ulcers, Mucositis to

toxicity and erythema, extensive extent that
scale1 erythema patient can erythema, alimentation
swallow patient cannot not possible
solid diet swallow solid
diet
Yellow highlighted text indicates key driver(s) for each guide

1. World Health Organization. Handbook for reporting results of cancer treatment 1979;pp15–22

7
Providing optimal training
Becky Stone (UK)
Mary Uhlenhopp (Amgen Europe)
Mary Uhlenhopp is Clinical Education Manager for Oncology at Amgen.
An oncology Clinical Nurse Specialist with a Masters of Science in
Oncology Nursing from Columbia University, New York City, US, she
currently works to develop educational programmes and initiatives for
nurses, physicians and patients. In particular, Mary has worked closely
with the European Oncology Nursing Society to develop the Training
Initiative for Thrombocytopenia, Anaemia and Neutropenia (TITAN)
that is being delivered in 2005–2006 in over 23 countries and in
17 different languages. Mary has extensive experience of working with
breast cancer patients and oncology patients in acute and intensive care
settings. She has also had several years’ involvement in the area of head
and neck surgical oncology.

The role of a trainer is to optimize accuracy and concordance by assuring that assessments
are correct and standardized. Prior to training, trainers should prepare presentations carefully
in advance and it is helpful to use patient examples to promote discussion. Trainers should
contact key people in the organization where training will be held to gain their commitment to
release nurses for training and to secure an appropriate training environment. An optimal
training environment is a quiet, well-lit venue with sufficient time for training. During training,
aims must be stated clearly at the beginning and key points delivered carefully and succinctly.
Sessions should be interactive and practical, using examples and a ‘hands on’ approach
wherever possible. Trainers should ensure that appropriate lighting and tools (POMA training
materials, gloves, halogen lamp, tongue depressor, gauzes) are available. In order for training
to be optimal, it is best to address a small group of nurses, which will ensure the trainer can
check that all attending nurses are performing the assessments accurately. With appropriate
training, the accuracy of oral mucositis assessments can be improved, and interim results from
the audit have shown that the Train-the-Trainer approach is an effective way to ensure that
nurses complete oral assessments consistently.

8
Key slides

Points to remember

• Ask permission from the patient first!

• Patients may have mucositis before ulcers become visible
• The number / size of ulcers is not a driver of the WHO scale
• Presence / absence of erythema does not affect the WHO score
• When scoring for pain or ability to eat, ensure that this relates to
OM and not to another related cause
• Grading scores can be affected by the use of local anaesthesia
• Use caution when grading – if you are unsure, assign a higher
rather than a lower grade

Assessor training and accuracy

Site No. of No. of % accurate Trained/

patients evaluations untrained
assessors
5 trained
A 25 585 92
0 untrained

3 trained
B 18 361 83
2 untrained

• Accuracy with no proper training: 62.87%

• Accuracy with proper training: 87.95%

Sonis S. Personal communication

Importance of assessor training

100

80
Accuracy (%)

60

40
Trained
20 Untrained

0
1 2 3 4 5
Study quarter
Sonis S. Personal communication

9
Future directions in the management
of oral mucositis
Nicole Blijlevens (The Netherlands)
Dr Nicole Blijlevens holds a tenured position in the Department of Haematology
at the University Medical Centre Nijmegen (UMC) St Radboud,
The Netherlands. Since joining UMC St Radboud, Dr Blijlevens has been active
in the field of infectious complications in recipients of haematopoietic stem cell
transplants. She has been involved in several clinical trials, has published numerous
articles relating to chemotherapy-induced mucosal barrier injury affecting stem cell
transplant recipients and has gained her PhD in ‘Mucosal barrier injury and stem
cell transplant recipients’. A member of the EBMT and the EBMT Working Party
on Chronic Leukaemia, Dr Blijlevens – along with Professor Sean McCann
(Dublin) – also co-chairs the Prospective Oral Mucositis Audit in Europe, a
combined investigation with Amgen of EBMT transplant centres, which assesses
oral mucositis following autologous stem cell transplantation.

Oral mucositis (OM) is a debilitating complication of cancer therapy that causes substantial
morbidity and an increased risk of mortality.1 Despite the numerous publications and attention
that have been focused on OM in recent years, there is a lack of routine assessment utilizing
consistent tools, and few effective therapies are available for its treatment. It is important to be
able to describe, classify and measure the extent, progression and severity of OM for two
reasons: firstly, to calculate the incidence of OM induced by myeloablative treatments for
haematopoietic stem cell transplantation (HSCT); and secondly to evaluate the efficacy of
drugs that might reduce the duration and severity of OM. In recent years, significant advances
have been made in our understanding of the pathophysiology of OM and factors that might
benefit patients suffering from this toxicity. In particular, recombinant forms of human growth
factors are in development. The Mucositis Study Group of the Multinational Association of
Supportive Care in Cancer and the International Society for Oral Oncology (MASCC/ISOO)
have addressed issues around OM treatment and research, including pathophysiology,
epidemiology, oral care, education, guidelines, treatment and pain management.2 An update of
the subsequent Mucositis Management Guidelines was completed in 2005 and recommends
the use of novel agents for the management of OM in patients undergoing autologous HSCT.3

1. Sonis ST et al. Cancer 2004;100(Suppl.):1995–2026

2. Rubenstein EB et al. Cancer 2004;100(Suppl.):2026–46
3. Mucositis Guidelines Update 2005. Available at: www.MASCC.org

10
Key slides

Consequences of oral mucositis

41* will develop infection…

and 5 will die

*Total n=55

Elting et al. Cancer 2003

Oral mucositis and different

conditioning regimens

MEL
Mean WHO mucositis score

4.0
MEL-TBI
3.0 BUS
BUS-C
2.0 C-TBI
C-BCNU
1.0
CVB
0.0
1 7 14 21 28

MEL, melphalan; MEL-TBI, melphalan + total body irradiation;

BUS, busulfan; BUS-C, busulfan + cyclophosphamide;
C-TBI, cyclophosphamide + total body irradiation;
Adapted from Wardley et al. C-BCNU, cyclophosphamide + carmustine;
Brit J Haematol 2000;110:292–9 CVB, cisplatin + vindesine + bleomycin

There is little evidence to support the use of

many current treatments for OM1
Sucralfate Epidermal growth factor
Prostaglandins E1, E2 G-CSF / GM-CSF topically / i.v.
β-carotene Oral hygiene
Lidocaine Opioids
Silver nitrate Benzydamine hydrochloride
Hydrogen peroxide Amifostine
Indomethacin Cryotherapy
Pentoxifylline Lactoferrin
Human IgG EN3247 (Triclosan)
Chlorhexidine Glutamine
Propantheline Low-level laser therapy
Rinses – bland Transforming growth factor β3
Rinses – antimicrobial agents Interleukin 15
Protegrin iseganan HCL Interleukin 11
1. Mucositis Guidelines Update 2005. Avalable at www.MASCC.org

11
Notes

12
© 2006 Amgen Inc. All rights reserved
PO-AMG-076-2006
03/2006