Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Stomatitis

Mucositis

Oropharyngeal Neoplasms

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Hypopharyngeal Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Herbal and Botanical

Kava

Mouthwash with Homeodent® is started on the first day of irradiation, then continued until the end of the irradiation period or until occurrence of grade ≥3 mucositis. In case of grade ≥3 mucositis, patients are instructed to mouthwash with Sodium Bicarbonate solution until complete disappearance of mucositis or until the end of irradiation.

Mouthwash with sodium bicarbonate is started on the first day of irradiation, then continued until the end of the irradiation period. In case of grade ≥3 mucositis, mouthwash is continued until complete disappearance of the mucositis or until the end of irradiation.

In both arms, after the end of irradiation, patients can receive treatment with Sodium Bicarbonate solution until complete disappearance of the mucositis.

Two-minute mouthwash with 5 ml of solution diluted in 125 ml of water, 3 times per day after meals and tooth brushing.

Homeodent®

Two-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing

1.4% Sodium Bicarbonate solution

Pascal POMMIER

The purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer.

This is a phase III, controlled, randomized, single blind study. The estimated inclusion period is approximately 24 months. The number of patients required in this monocentric study is 330 (165 per arm).

The standard treatment of oral cavity, oropharynx, hypopharynx, and cavum cancers is external radiotherapy. However, one of the associated toxicities is the occurrence of mucositis which can be a limiting factor in the treatment (dose reduction or treatment interruption can limit patient's survival), patient's quality of life decreases and severe complications can occur. The treatment of mucositis is mainly symptomatic; a randomized study has shown a benefit of a mouthwash with Benzydamine, a non steroidal anti-inflammatory drug, for patients receiving 50-Gy radiation. Another study with a lower number of patients has also shown a benefit of using a zinc sulfate solution. Boiron laboratories have developed a phytopharmaceutical preparation, Homeodent®, which has no secondary effects and which could prevent radiation-induced mucositis. This study will evaluate the efficiency of mouthwash with Homeodent® in a large randomized trial.

Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer

Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer

BOIRON

Centre Leon Berard

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Diseases

Anus Diseases

Rectal Diseases

Neoplasms, Squamous Cell

Anal Cancer

Antineoplastic Agents

Fluorouracil

Mitomycins

Mitomycin

Panitumumab

Antineoplastic Agents, Immunological

5 FU = 400 or 600 or 80 or 1000 mg depending of phase I results, days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 or 6 mg/kg (depending of phase I results) days 1, weeks: 1, 3, 5, 8 and 10

Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²

radiochemotherapy

Véronique VENDRELY, MD

Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.

The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).

Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).

It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.

Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.

Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus

Federation Francophone de Cancerologie Digestive

Esophageal Achalasia

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Idiopathic Achalasia

Cardiospasm

Achalasia patients were periodically submitted to clinical assessment, barium swallow (esophageal diameter and residual barium column were measured), endoscopy. Mucosal esophageal biopsies were taken in order to diagnose dysplasia or epidermoid carcinoma.

Clinical instrumental examinations

Sandro Mattioli, MD

Marisaluisa Lugaresi, MD

Marialuisa Lugaresi, MD

Valentina Tassi, MD

Niccolò Daddi, MD

Benedetta Mattioli, MD

Francesca Fortunato, PhD

Rocco Maurizio Zagari, MD

Francesco Bassi, MD

Vladimiro Pilotti, MD

Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.

In order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. The local institutional review board approved using the database from the division of thoracic surgery for research purposes. Clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.

Epidermoid Cancer Development in Esophageal Achalasia

Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia

Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy

Result of achalasia treatment assessed by means of semiquantitative grading scales of dysphagia and gastro-esophageal reflux

Sandro Mattioli

Prof. Sandro Mattioli

Skin and Connective Tissue Diseases

Wounds and Injuries

Symptoms and General Pathology

Carcinoma, Neuroendocrine

Melanoma

Skin Neoplasms

Neoplasm Metastasis

Lymphatic Metastasis

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplastic Processes

Adenocarcinoma

Neuroendocrine Tumor

Neuroepithelioma

A vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors

A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors

A negative pressure wound closure therapy is used after lymph node dissection

PREVENA

Manuela PEREZ

In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.

Lymphorrhoea, lymphedema and lymphocyte are significant and common complications after axillary and inguinal lymph nodes dissections. A vacuum assisted closure therapy should prevent these comorbidities. In this study, we compared PREVENA, a negative pressure wound therapy, versus conventional dressings. We evaluated the wound complications at the seventh day, the thirtieth day and at this end of the first year after surgery. It is a retrospective study of about ninety lymph nodes dissections among with there were seventy times the use of a negative pressure wound therapy, PREVENA.

The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors

Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?

Yes if there is a scar opening, no if there isn't

Yes if there is lymph coming from the the scar, no if there isn't.

Yes if there is any lymphocele puncture, no if there isn't

Yes if there is arm or leg lymphoedema, no if there isn't

Central Hospital, Nancy, France

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer	NCT01066741	Oropharynx Canc... Hypopharynx Can...	Homeodent® 1.4% Sodium Bic...	18 Years - 85 Years	Centre Leon Berard
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus	NCT01581840	Epidermoid Carc... Anus	radiochemothera... Panitumumab	18 Years -	Federation Francophone de Cancerologie Digestive
Epidermoid Cancer Development in Esophageal Achalasia	NCT03546998	Achalasia Epidermoid Carc...	Clinical instru...	-	University of Bologna
The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors	NCT04583605	Melanoma Skin Cancer Epidermoid Carc... Neuroendocrine ... Lymph Node Meta...	PREVENA	18 Years -	Central Hospital, Nancy, France
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus	NCT01581840	Epidermoid Carc... Anus	radiochemothera... Panitumumab	18 Years -	Federation Francophone de Cancerologie Digestive
Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer	NCT01066741	Oropharynx Canc... Hypopharynx Can...	Homeodent® 1.4% Sodium Bic...	18 Years - 85 Years	Centre Leon Berard
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus	NCT01581840	Epidermoid Carc... Anus	radiochemothera... Panitumumab	18 Years -	Federation Francophone de Cancerologie Digestive
Epidermoid Cancer Development in Esophageal Achalasia	NCT03546998	Achalasia Epidermoid Carc...	Clinical instru...	-	University of Bologna

Spots Global Cancer Trial Database for epidermoid carcinoma