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6th ICHNO
page 61
6
th
ICHNO Conference
International Conference on innovative approaches in Head and Neck Oncology
16 – 18 March 2017
Barcelona, Spain
__________________________________________________________________________________________
PO-127 Melatonin oral gel for prevention oral mucositis
head and neck cancer undergoing chemo/bio radiation
(MUCOMEL)
A. Lozano
1
, J. Marruecos
2
, N. Farre
3
, J. Giralt
4
, R. Morera
5
,
I. Planas
6
, M. Lanzuela
7
, A. Escribano
5
, L.A. Glaria
5
, R.
Mesia
8
, J. Rubio
9
, A. Lopez-Pousa
10
, N. Baste
11
, B.
Castelo
12
, B. Cirauqui
13
, J. Martinez-Trufero
14
, J. Ortiz
15
,
P.M. Grima
15
, V. Valenti
16
, C. Tarrago
15
, R. Bosser
15
1
Institut Català d'Oncologia, Radiation Oncology,
L'Hospitalet de Llobregat, Spain
2
Institut Català d'Oncologia, Radiation Oncology, Girona,
Spain
3
Hospital Universitari de la Santa Creu i Sant Pau,
Radiation Oncology, Barcelona, Spain
4
Hospital Universitari de la Vall d´Hebron, Radiation
Oncology, Barcelona, Spain
5
Hospital Universitario La Paz, Radiation Oncology,
Madrid, Spain
6
Institut Catala d´Oncologia, Radiation Oncology,
Badalona, Spain
7
Hospital Universitario Miguel Servet, Radiation
Oncology, Zaragoza, Spain
8
Institut Català d'Oncologia, Medical Oncology,
L'Hospitalet de Llobregat, Spain
9
Institut Català d'Oncologia, Medical Oncology, Girona,
Spain
10
Hospital Universitari de la Santa Creu i Sant Pau,
Medical Oncology, Barcelona, Spain
11
Hospital Universitari de la Vall d´Hebron, Medical
Oncology, Barcelona, Spain
12
Hospital Universitario La Paz, Medical Oncology,
Madrid, Spain
13
Institut Català d'Oncologia, Medical Oncology,
Badalona, Spain
14
Hospital Universitario Miguel Servet, Medical Oncology,
Zaragoza, Spain
15
Spherium Biomed S.L., Project Management, Esplugues
de Llobregat, Spain
16
Hospital de Santa Tecla, Medical Oncology, Tarragona,
Spain
Purpose or Objective
Oral mucositis (OM) is the most significant adverse event
(AE) in patients undergoing concurrent chemo/biotherapy
plus radiotherapy for treating head and neck (H&N)
cancer.
The objective of the ongoing Phase Ib-II trial is to evaluate
the safety of melatonin (MLT) oral gel, its efficacy in the
prevention of severe OM in H&N cancer patients (84) and
to assess the pharmacokinetic profile of MLT in the
subgroup of the first 24 patients.
Material and Methods
Prospective, randomized, double blind and placebo-
controlled study. Eligible patients are assigned at 1:1 ratio
to receive 3% melatonin or matching placebo oral gels
(mouthwashes followed by swallowing).
All patients receive concomitant standard symptomatic
treatment for OM along the study, according to the clinical
practice of the hospitals.
All patients take MLT oral-gel or placebo oral gel from two
to three days before start of systemic treatment until one
to four weeks after completion of radiotherapy. Eight
additional weeks of observation are needed to rule out
late-onset adverse events related to MLT.
The selected radiotherapy is VMAT-SIB once daily (5 days
a week), 50.4 Gy (low risk area), 69.96 Gy (high risk area)
and 66 Gy (post-operative oral cavity tumour).
Radiotherapy plan was previously agreed between all the
radiotherapists participating in the study in order to
ensure homogeneity between centres. Concurrent
systemic treatment is either cisplatin or cetuximab.
Primary endpoint:
Num. of patients with severe OM (G3-
G4 / RTOG).
Secondary endpoints:
Efficacy: Num. of patients with SOM (G3-G4 / NCI-CTCAE),
Num. of days with OM (RTOG), Num. of days with G3-G4
OM (RTOG), Time to onset of G3-G4 OM (RTOG)
Quality of Life: Change from baseline in EORTC QLQ-C30
& EORTC QLQ-H&N35 scores ,Change from baseline in
ECOG-PS
Safety: Num. of patients with G1-G4 NCI-CTCAE rel. to IMP
, Num. of patients who develop cisplatin or cetuximab-
associated G1-G4 AEs (NCI-CTCAE)., Num. of patients who
develop RT-associated AEs different from OM (RTOG)
PK: C
max
, C
min,
T
max
, AUC, T
1/2
, V
d
, Clearance (Cl)
Results
The first patient was enrolled in November 2015 and, up
to 10 October 2016, 40 patients were randomized to
treatment with either MLT or placebo oral gel. Results are
expected by mid of 2017.
Conclusion
This prospective, randomized, double-blind and placebo-
controlled study will demonstrate if melatonin oral gel 3%
is safe and has been able to prevent severe OM in H&N
cancer patients undergoing QRT, and if has shown efficacy
in the other evaluated endpoints.
PO-128 Follow up dysphagia in head and neck cancers
is related to RT dose received by swallowing structures
K. George
1
, R. Bhalavat
1
, M. Chandra
1
, L. Nellore
1
, D.
Borade
1
, K. Kalariya
1
, V. Pareek
1
, Z. Moosa
1
, N. Reddy
1
, A.
Srivastava
1
1
Jupiter Hospital- Thane, Radiation Oncology, Thane,
India
Purpose or Objective
To study relationship of radiation dose received by
Dysphagia and Aspiration Related Structures (DARS) and
degree of dysphagia in head and neck cancers post radical
radiation therapy (IMRT) with or without Chemotherapy
(CT). If positive correlation exists, then assess the dose to
DARS in patients previously treated with Brachytherapy
boost and suggest Brachytherapy as a good boost modality
to further reduce dysphagia and aspiration.
Material and Methods
42 patients of head and neck cancers, satisfying the
inclusion criteria were included from April 2014 to May
2015 and were treated with radical IMRT. DARS structures
which included superior (SC), middle (MC) and inferior
constrictors (IC), supraglottic (SGL) and glottic larynx (GL)
and cervical esophagus (CE) were contoured on the
planning CT scan along with other Organs at risk (OAR’s).
Dysphagia was evaluated at baseline and at 6 months post
treatment using Subjective questionnaires M.D Anderson
Dysphagia Inventory (MDADI) and Performance Status
Scale for Head and Neck Cancers (PSSN) and using Modified
Barium
Swallow
for
Objective
Scoring
of
dysphagia: Swallowing Performance Scale (SPS) and
Penetration
Aspiration
Scale
(PAS).
42 patients of cancer of the pharynx and larynx who were
treated with EBRT followed by Brachytherapy boost from
2009 to 2016 were also evaluated (dosimetrically)
retrospectively.
Results
On applying non-parametric correlation, there’s
correlation between V30 of SC and the PSSN Score at 6
months and Dmax of SC and PSSN score at 6 months. For
MDADI scores, there’s a positive relationship of Dmax of
SC and 6 month MDADI score. There’s correlation between
V30, V50, V60, V66, V70, Mean doses of MC and the PSSN
Score at 6 months; For MDADI scores, there’s a positive
relationship of V30, V50, V60, V66 and V70 of MC and 6
month MDADI score. There’s correlation between V30, V50