Xerostomia

Asialia

Hyposalivation

Mouth Dryness

Aqualief

Placebo

Fondazione IRCCS Istituto Nazionale dei Tumori

Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer

Evaluate the Effects of Aqualief® Mucoadhesive Tablets (a Food Supplement Based on Carnosine and Hibiscus) in Patients Who Developed Oral Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer

Change of saliva production, without mechanical stimulation.

Report from patients the facility to use and palatability of the product

Helsinn Healthcare SA

Latis S.r.l.

randomized, double blind, placebo controlled, cross over study

E-cigarette Use

Participants will vape with e-cigarettes radio-labeled with C-11 nicotine.

C-11 labeled nicotine

After vaping with radio-labeled e-cigarettes, participants will be PET/CT imaged.

PET/CT imaging

The Ohio State University Wexner Medical Center

Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use

We will measure the intensity of C11 labeled nicotine uptake, measured as SUV in different target and organ systems

We will measure the intensity of C11 labeled nicotine uptake, measured as SUV in the oral cavity, lungs, blood stream and brain

We will use the intensity of C11 labeled nicotine uptake, measured as SUV in the different target and organ systems in the PET imaging field of view and assess the change of uptake over time as a measure of its elimination

Michael V. Knopp MD, PhD

Professor

Ohio State University

Nornicotine level equal to highest commercial smokeless tobacco tested

Nornicotine level equal to mean of commercial smokeless tobaccos

Nornicotine level equal to lowest commercial smokeless tobacco tested

Nornicotine level equal to 50% of commercial smokeless tobaccos

Nornicotine level equal to 10% of commercial smokeless tobaccos

Nornicotine level equal to 5% of commercial smokeless tobaccos

Control group - Herbal snuff only, no Nornicotine

Tobacco Toxicity

Level equal to highest level of [D4]Nornicotine found in commercial tobacco based snuff

[D4]Nornicotine - Highest

Level equal to mean level of [D4]Nornicotine found in commercial tobacco based snuff

[D4]Nornicotine - Mean

Level equal to lowest level of [D4]Nornicotine found in commercial tobacco based snuff

[D4]Nornicotine - Lowest

Level equal to 50% of the lowest level of [D4]Nornicotine found in commercial tobacco based snuff

[D4]Nornicotine - 50% Lowest

Level equal to 10% of the lowest level of [D4]Nornicotine found in commercial tobacco based snuff

[D4]Nornicotine - 10% Lowest

Level equal to 5% of the lowest level of [D4]Nornicotine found in commercial tobacco based snuff

[D4]Nornicotine - 5% Lowest

0.5µg/g - below traditional levels found in moist snuff

13C6-NNN

A tobacco-free herbal snuff, such as Smokey Mountain or similar

Herbal Snuff

University of Minnesota

Labeled Nornicotine in Smokeless Tobacco

Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure

Urinary excretion daily for 1 day prior and 3 days after 30 minutes exposure, on 3 separate occasions, 20 days apart

National Cancer Institute (NCI)

vinflunine IV 280 mg/m² Day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks

methotrexate IV 40 mg/m² Day 1, 8 and 15 every 3 weeks

Vinflunine IV 280 mg/m² day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks
Vinflunine

Vinflunine Plus Methotrexate

Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks
Methotrexate

Methotrexate

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

Time from randomization to the date of death or last follow-up. The survival duration of patients still alive, was censored at the date of last contact or last follow-up.

Overall Survival in the ITT Population (Months)

Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)

Progression Free Survival

The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.

Objective Response Rate (ORR)

Percentage of best overall responses CR, PR and SD in the analysed population

Disease Control Rate

Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.

Duration of Response

Overall Study

Zahida Issiakhem, Clinical Development Physician

Vinflunine IV 280mg/m2 Day1 plus Methotrexate IV 30mg/m2 on Day 1 and Dy 8 every 3 cycles
Vinflunine

Recurrent or Metastatic Head and Neck Carcinoma

Vinflunine

Institut de Recherche Pierre Fabre

Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer

Phase III Study of IV Vinflunine in Combination With Methotrexate Versus Methotrexate Alone in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Chemotherapy

alkaloid/dental caries

Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer

Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use

Labeled Nornicotine in Smokeless Tobacco

Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer

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