Neoplasms

All Conditions

Mouth and Tooth Diseases

Head and Neck Neoplasms

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Herbal and Botanical

All Drugs and Chemicals

Hibiscus

Aqualief

Placebo

Ester Orlandi, MD

The treatment of xerostomia is aimed to increase existing saliva flow or replace lost secretions, the control of the state of oral health, the control of dental caries, and the treatment of possible infections.

Therapy options in xerostomia depend on the presence of residual secretion or the absence of it. When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.

Aqualief® is a food supplement based on carnosine and hibiscus. These two ingredients are mixed in specific proportions to form a pH buffering system which maintains the pH of the oral cavity at the proper value which is required for the regular secretion of saliva.

Xerostomia is the biggest and chronic side effect of the RT for head and neck cancer. To treat xerostomia different approach should be followed at the same time: to increase existing saliva flow or replace lost secretions, to control the state of oral health, to control dental caries and to treat possible infections18.

When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.

The salivary flow can be stimulated by the use of sugarless chewing gum or xylitol/sorbitol candy or through parasympathomimetic drug such as pilocarpine. Pilocarpine is a natural alkaloid that activates cholinergic receptors, authorized to treat xerostomia. Due to its main mechanism of action, pilocarpine has some muscarinic side effects19, especially vomiting, sweating, headache, increased urinary frequency, wheezing, watery eyes, nausea and gastrointestinal intolerance, hypotension, rhinitis, diarrhea, and visual disturbances. Pilocarpine has also some use restrictions that make it not prescribable to certain patients (patients with asthma, high blood pressure, heart diseases and in therapy with β-blockers cannot use pilocarpine because this drug is a nonselective antagonist of muscarinic receptors and, therefore, it can interfere with the cardiac and respiratory functions).

Acupuncture seems to alleviate radio-induced xerostomia but it mechanism of action is not totally clear and systematic reviews indicate its efficacy as doubtful20,21.

Other products are under investigation and their efficacy in xerostomia due to RT is still unclear.

Aqualief® is a food supplement based on carnosine and hibiscus. These two ingredients are mixed in specific proportions to form a pH buffering system which maintains the pH of the oral cavity at the proper value which is required for the regular secretion of saliva.

Aqualief® is designed as a mucoadesive tablet that will adhere to the cheek internal side, to have a prolonged action. It is expected to gradually release the ingredients over a period of at least two hours.

Aqualief® is being tested in a clinical study on 70 subjects with grade 1-2 xerostomy enrolled at the Dental Clinic of the University of Insubria. The study is currently ongoing therefore results are not yet available.

The aim of this clinical study is to evaluate if Aqualief® can be efficacious in the increasing of the saliva production in patients suffering for xerostomia as consequence of previous RT for head and neck cancer.

To this purpose, this double blind cross over study has been designed: 100 patients will be treated for 8 days with Aqualief®/placebo and then, following a 10 days wash-out period, for further 8 days with placebo /Aqualief®.

randomized, double blind, placebo controlled, cross over study

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

Latis S.r.l.

Helsinn Healthcare SA

Ear, Nose, and Throat Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms

Carcinoma

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Acupuncture Before the Radiation Treatment

Acupuncture for 20 minutes before the radiation therapy session, 3 days a week for 7 weeks.

Acupuncture

Standard Care

Joseph S. Chiang, MD

The goal of this clinical research study is to learn if acupuncture is effective in preventing xerostomia (dry mouth) in cancer patients who receive radiation treatment to the head and neck area. Researchers also want to learn whether acupuncture lowers the severity of dry mouth that is experienced by these patients.

Primary Objective:

-Investigate if acupuncture is effective in preventing xerostomia among cancer patients at Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the head and neck area.

Secondary Objectives:

* Determine whether acupuncture reduces the severity of xerostomia.
* Determine the feasibility of providing acupuncture treatment to patients at Cancer Hospital who are receiving radiation treatment for cancer of the head and/or neck area.

Some research suggests that acupuncture may be helpful in stimulating saliva flow in patients with dry mouth caused by radiation treatment. Acupuncture uses very thin needles inserted at certain points on the body that are believed to affect bodily functions.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded, and you will have a physical exam. You will also be asked to complete 3 short questionnaires about your quality-of-life and current saliva flow. These should take about 5 minutes to complete. You will be asked to collect saliva in a vial (small tube or jar) for 5 minutes, by allowing saliva to collect in your mouth and then spitting it into the vial. You will be asked to collect saliva twice at each time point. One collection will be like it is described above. The second collection will be after you have held a sour liquid in your mouth for 1 minute. A traditional Chinese medicine diagnosis will also be conducted. This will include diagnosis by a doctor as well as by using a heart-rate machine and taking a photograph of your tongue. This will allow a more objective check of your heart rate and tongue condition.

If you are found to be eligible to take part in the study, you will be randomly assigned (as in the toss of a coin) into 1 of 2 groups. One group will receive acupuncture during their radiation treatment period, and the other will receive standard care without acupuncture. Participants assigned to the acupuncture group will receive acupuncture for 20 minutes before their radiation therapy session, 3 days a week for 7 weeks. Participants in the standard care group will not receive acupuncture.

If you are in the acupuncture group, you will be asked to come to the acupuncture clinic for the treatment, before your radiation treatment. The acupuncturist will put in the needles in certain points of your body (including the chin, wrist, leg, and ear), while you are seated in a chair. The needles will remain in for about 20 minutes.

If you choose to receive medications for dry mouth at any point while on study, your participation on this study will end.

No matter which group you are assigned to, for each of the 7 weeks you are receiving radiation treatment, your vital signs (your blood pressure and pulse) will be checked, and you will be asked about any medications you are taking. You will also complete questionnaires about your quality-of-life and symptoms. Each questionnaire should take about 5 minutes to complete. A saliva sample will also be collected on Weeks 1, 3, 4, 6, and 7. If you are assigned to the acupuncture group, the saliva sample will be collected after the acupuncture treatment on Weeks 1, 4, and 7 and before the treatment on Weeks 3 and 6. A traditional Chinese medicine diagnosis will also be conducted in the middle of radiation treatment, at the end of treatment, and 1 month later. This will include diagnosis by a physician as well as by using a pulse machine and taking a photograph of your tongue.

One month after the end of radiation treatment (Week 11), your vital signs will be checked, you will be asked about any medications you are taking， you will complete the quality of life and symptom questionnaires, and you will provide another saliva sample. After Week 11, your participation on this study is over.

This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at the Fudan University Cancer Hospital.

Acupuncture for Prevention of Radiation-Induced Xerostomia

Severity of the xerostomia in both groups compared by testing for group differences in xerostomia scores between baseline and week 7 using a two-sample (unpaired) t test. Repeated measures analyses used in order to detect overall differences in severity over time, differences between groups and the interaction between time and group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer	NCT03601962	Xerostomia Asialia Hyposalivation Mouth Dryness	Aqualief Placebo	18 Years -	Helsinn Healthcare SA
Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer	NCT03601962	Xerostomia Asialia Hyposalivation Mouth Dryness	Aqualief Placebo	18 Years -	Helsinn Healthcare SA
Acupuncture for Prevention of Radiation-Induced Xerostomia	NCT00430378	Xerostomia Mouth Dryness Nasopharyngeal ...	Acupuncture Standard Care	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for mouth dryness