Healthcare Professionals
Message to Healthcare Professionals
ProThelial™ is associated with superior patient outcomes according to its FDA
Phase IV Postmarket Mucositis Registry Data
The following cases are patients on the Mucositis Registry who experienced reversal of
mucositis using ProThelial™ (polymerized cross-linked sucralfate). Their experiences
were typical for the over 65 patients on the Registry.
Case 1. Squamous Cell Carcinoma of Head and Neck – On Cetuximab &
Radiation – 49-year-old Male
A 49-year-old male under the care of a radiation oncologist of a midwestern university
affiliated teaching hospital for advanced stage 4 squamous cell carcinoma of the tonsil, was
treated with radiation combined with Cetuximab. By the end of the second week of treatment,
he developed Grade 2-3 oral mucositis and symptoms of upper and lower GI mucositis.
Cetuximab, is an epidermal growth factor receptor antagonist. In an FDA reviewed trial of 424 patients, SCCHN patients
(squamous cell carcinoma of head and neck), Cetuximab plus radiation extended cancer survival from 29 months using
radiation alone to 49 months 14. However, the addition of Cetuximab to radiation increases incidence of alimentary
mucositis (nausea 49% vs 37%, emesis 29% vs 23%, diarrhea 19% vs 13%), of delayed-onset radiation oral mucositis
(48% vs 39%) and delayed onset esophageal mucositis (44% vs 35%).
PCLS (500mg -1 teaspoon of polymerized cross-linked sucralfate twice daily) reversed Grade
2-3 mucositis in this patient in 3 days. Pain at rest and upon swallowing was eliminated, as
was the use of narcotic analgesic for pain. Nausea, cramping and loose stools subsided as well.
Self-alimentation continued during cancer treatment. The patient tolerated PCLS well and
reported no adverse reaction.
Case 2. Esophageal Mucositis - Pancreatic Adenocarcinoma on FolFirinox
– 48-year-old Male
A 48-year-old male under the care of a medical oncologist at a comprehensive cancer center for
metastatic Stage 4 pancreatic carcinoma was treated with Folfirinox. By week 2, the patient
developed Grade 3-4 oroesophageal mucositis, nausea and loose stools. He was unable to
tolerate solids and liquids and became entirely dependent on tube feeding.
Pancreatic adenocarcinoma is the fourth-leading cause of cancer-related death, with nearly 37,000 deaths as of 2010. The
overwhelming majority, above 90%, of these patients are inoperable at presentation, making systemic chemotherapy the primary
form of treatment. Gemcitabine, which at one time replaced fluorouracil, has itself been replaced by Folfirinox, which is
a chemotherapy combination of 5-fluorouracil, folinic acid, irinotecan and oxaliplatin. Folfirinox extended patient
survival from 6.8 to 11.1 months. Not surprisingly, it is attended by high grade 3/4 hematologic toxicities with grade
3/4 oral and alimentary mucositis.
This patient was placed on ProThelial™ by the oncologist and was instructed by the physician to
swish and swallow PCLS, 500mg (one teaspoon) three times on day 1, then twice daily thereafter).
The patient experienced (a) complete reversal of oral ulcerations in 3 days, (b) ability to
swallow without pain in 3 days (c) simultaneous reversal of nausea and diarrhea and (d)
restoration of ability to eat a regular diet with complete oral alimentation. Patient tolerated
PCLS well and no adverse reaction was reported.
Case 3. Oral & Colonic Mucositis – SCCHN on Paclitaxel, Carboplatin, Radiation
– 43-year-old Male
A 43-year-old male with advanced head and neck squamous cell carcinoma requiring concurrent
chemo-radiation. He received six (6) weekly infusions of Paclitaxel and Carboplatin combined
with radiation totaling 201 Gy (71Gy for base of tongue, 71Gy to the tumor mass with an
additional radiation dose of 59Gy to regional nodes).
Two weeks into chemo-radiation, he developed Grade 2 oral mucositis with dysgeusia and
xerostomia and Grade 2 alimentary mucositis. He was prescribed PCLS, 1.5gm doses to be swished
and swallowed three times daily for 2 days, then twice daily thereafter.
An Episode of Non-compliance: Having forgotten, patient self-discontinued PCLS during cancer
treatment. Four days later, both oral (Grade 2) and gastrointestinal mucositis (Grade 2) returned,
prompting patient to resume PCLS. Without a loading regimen, patient resumed PCLS using 1.5
grams to swish and swallow twice daily. Both oral and gastrointestinal mucositis resolved within
2 days. Patient tolerated PCLS well and no adverse reaction was reported.
Case 4. Oral, Small Bowel, Colonic Mucositis – Melanoma on Ipilimumab & Nivolumab
48 year old Female
A 48 year old female with advance stage widely metastatic melanoma, her primary lesion excised
from mid-right back, went on to developed metastasis to regional nodes, both lung pleura,
stomach, adrenals and brain. She was treated with ipilimumab and nivolumab and developed
Grade 3 oral mucositis and Grade 3-4 chemo-induced diarrhea associated with nausea and vomiting.
Being prescribed PCLS by her physician (1,000 mg -2 teaspoons - to swish and swallow), the oral
mucositis was reversed in two days as did the chemo-induced diarrhea. Prior to PCLS, she had
been maintained on pantoprazole, ondansetron, and diphenoxylate-atropine without significant
effect for weeks. Symptom control occurred shortly (2-3 days) following introduction of PCLS.
Oral ulcerations, pain and vomiting resolved completely. However post-prandial nausea and
crampiness persisted though diminished significantly. Frequent bouts of diarrhea were replaced
by normal movements of formed stool. Patient tolerated PCLS well and no adverse reaction was
reported.
