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

After a double-blind rabdomization, patients allocated to the experimental group will be followed for four weeks beginning at the start of their hospitalization, after signing a consent form. After completing baseline self-report measurements, they will be assessed for the severity of their symptoms; their working alliance with their therapist; and their treatment outcome after each session. Psychotherapy will be delivered twice a week. Intranasal OT will be administered twice a day (at 08:00 a.m. and at 17:00 p.m.). The experimental group will receive - 32IU (16IU*2) of OT, Sorbitol, Benzyl, alcohol glycerol, distilled water. OT will be inhaled in two sprays, one in each nostril.The substance for both study groups will be prepared in the hospital pharmacy, (in identical bottles), after randomization that will be conducted by the pharmacist. A month post intervention, patients will complete self-report measurements as part of a follow-up evaluation.

After a double-blind rabdomization, patients allocated to the placebo group will be followed for four weeks beginning at the start of their hospitalization, after signing a consent form. After completing baseline self-report measurements, they will be assessed for the severity of their symptoms; their working alliance with their therapist; and their treatment outcome after each session. Psychotherapy will be delivered twice a week. Intranasal Placebo will be administered twice a day (at 08:00 a.m. and at 17:00 p.m.). The placebo group will receive - 32IU (16IU*2) of Sorbitol, Benzyl, alcohol glycerol, distilled water, meaning all ingredients except for the OT and will be inhaled in two sprays, one in each nostril.The substance for both study groups will be prepared in the hospital pharmacy, (in identical bottles), after randomization that will be conducted by the pharmacist. A month post intervention, patients will complete self-report measurements as part of a follow-up evaluation.

Depression, Anxiety

32IU (16IU*2) of OT, Sorbitol, Benzyl, alcohol glycerol, distilled water.

Intranasal Oxytocin

32IU (16IU*2) of Sorbitol, Benzyl, alcohol glycerol.

Intranasal Placebo

Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness

Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness: A Randomized Controlled Study

As measured repeatedly by the Hopkins symptoms checklist -short form (HSCL-11) (Lutz, Tholen, Schurch, & Berking, 2006)

As measured by the 6 item Working Alliance Inventory (WAI-6) (Falkenström, Hatcher, Skjulsvik, Larsson, & Holmqvist, 2014)

As measured by the self-report measurement of Adult Attachment (Brennan, Clark & Shaver, 1998)

sorbitol/peavalu

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

Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness

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