Neoplasms

All Conditions

Mouth and Tooth Diseases

Head and Neck Neoplasms

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Dimenhydrinate

Ethanol

The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)

The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)

Remineralizing Extreme Dry Mouth Spray with Xylitol

Alcohol-Free Moisturizing Dry Mouth Spray

Jonas T Johnson, MD

To identify the effectiveness of two mouth sprays at relieving symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.

To assess patient quality of life and mouth acidity following use of two mouth sprays meant to relieve symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.

Investigators have observed that patients at the University of Pittsburgh Medical Center Head and Neck Survivorship clinic with symptoms of radiation-induced xerostomia expressed verbal preference for Biotene and Refresh mouth sprays (spray form of mouthwash) compared to other oral products such as gel, toothpaste, and chewing gum. Investigators have designed this study to specifically assess the effectiveness of mouth sprays on xerostomia in patients who have completed radiation for head and neck carcinoma. While there have been clinical trials to evaluate the effectiveness of Biotene oral products for xerostomia, Refresh mouthwash/mouth spray is a newer oral rinse formula that has not undergone any randomized controlled trials to evaluate its efficacy compared to other agents of its kind. The investigators have put forward this randomized controlled trial to compare the efficacy of both sprays to each other and to water. Biotene spray is cleared by the FDA as a medical device product. Currently, Refresh mouth spray falls under the FD\&C Act.

There is preliminary data on the effectiveness of Biotene mouthwash for xerostomia in patients who have had radiation of the head and neck. A phase II study of Biotene products (mouthwash, chewing gum, and toothpaste) were effective at improving many symptoms of post-irradiation xerostomia. Numerous other studies have shown that mouthwash and topical dry mouth products improve xerostomia symptoms.

Xerostomia, or mouth dryness, is a frequent side effect of head and neck cancer radiation therapy, as the salivary glands are often damaged during therapy. Radiation therapy can be successful in treating cancer, but post-irradiation xerostomia can cause oral discomfort as well as issues with eating, speech, and oral hygiene, leading to significantly decreased quality of life. While treatment of xerostomia has limited benefit, various mouthwashes have led to major symptomatic improvement in some patients. This study will add to existing literature by commenting on efficacy of a popular and established mouth spray used for xerostomia as well as a new mouth spray that has not been compared to existing formulas. A double-blinded randomized controlled trial evaluating these mouth sprays will add information about value of both formulas for head and neck carcinoma survivors with radiation-induced xerostomia.

Both subjects and clinicians will be blinded to Mouth Spray A and Mouth Spray B.

Blinded Dry Mouth Spray Crossover Study

Evaluation of Two Mouth Sprays for Post-irradiation Xerostomia in Head and Neck Cancer Survivors: a Randomized, Double-blind Clinical Trial

at the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics.

Dryness was measured on a 0-100 point scale "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"

sleeping difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Sleeping difficulty will be measured on a 0-100 point scale

"During the last three days, due to the dryness of your mouth and tongue, how difficult was it to sleep? Consider such factors as how difficult it was for you to go to sleep, the duration and quality of your sleep, and how often you woke up to drink or urinate. Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy" (Higher score means better outcome)

Speaking difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Speaking difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to speak without drinking liquids? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"

Alteration/impairment in sense of taste will be documented via questionnaire completion by participants administered via Qualtrics. Taste alteration/impairment will be measured on a 0-100 point scale "During the last three days, has your sense of taste been impaired or affected? Greatly Impaired/Affected 0 10 20 30 40 50 60 70 80 90 100 Not Impaired/Affected"

Swallowing and chewing difficulty due to oral dryness will be documented via questionnaire completion by participants administered via Qualtrics. Swallowing and chewing difficulty will be measured on a 0-100 point scale "During the last three days, overall, due to the dryness of your mouth and tongue, how difficult was it to chew and swallow food? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"

PH Is a measure of acidity on a logarithmic scale range 0 (most acidic) to 14 (most basic) with a neutral PH of 7 as the desired outcome.

Difficulty wearing dental prostheses (if applicable) will be documented via questionnaire completion by participants administered via Qualtrics. Dental prostheses wearing difficulty will be measured on a 0-100 point scale "If you normally wear dentures, due to the dryness of your mouth and tongue, how difficult was it to wear dentures during the last three days? (If you do not normally wear dentures or could not wear dentures for other reasons not associated with dry mouth, please check the box marked "Not applicable") Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy Not Applicable

TJA Health, LLC

Jonas Johnson

Principal Investigator

Participants who received biotene spray in either the 1st or 2nd two week trial period

Biotene Spray

Participants who received Refresh spray in either the 1st or 2nd two week trial period

Refresh Spray

The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)

Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray

Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray

Biotene Spray, Followed by Refresh Spray

The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)

Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray

Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray

Refresh Spray, Followed by Biotene Spray

Total

Age, Categorical

Sex: Female, Male

Only participants who completed the protocol were included in the analysis.

Race (NIH/OMB)

United States

Region of Enrollment

Patients responded to electronic survey; the questionnaire included continuous variables derived from the 100mm visual analog scale (VAS). "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"

Drymouth baseline

There may be a degree of attrition bias, our modified intention-to-treat design, in which 13 patients had to be reassigned to group 1 from group 2, may have also added bias; we found no evidence of a sequence effect. The treatment effect of each spray was calculated in reference to use of water, which is known to improve oral dryness so the magnitude of the treatment effect may be underestimated, however, we would expect both products to be affected equally.

Anne Fisher

Null hypothesis is that there was no difference in change of Dry mouth score between Refresh and Biotene. ANCOVA model was performed by regressing the difference in after-treatment measurement between Refresh and Biotene over the difference of baseline between Refresh and Biotene. The test was performed with a significance level of 0.05 (two- sided)

Oral dryness Dryness baseline

Dryness 2 weeks

Participants who received Biotene in either the first or last two week trial period of the study.

Participants who received Refresh spray in either the first or second two week period of the study.

Oral Dryness

Sleep Baseline

Sleep 2 weeks

Participants who received Biotene spray either in the first or last 2 week trial period.

Participants who received Refresh spray either in the first or second 2 week trial period.

Number of participants in analysis is less than overall number of participants due to missing responses.

Sleeping Difficulty Due to Oral Dryness

speaking baseline

speaking 2 weeks

Speaking Difficulty Score After Biotene Spray

Speaking Difficulty Score After Refresh Spray

The number of participants in analysis are lower in this specific analysis due to missing data

Speaking Difficulty Due to Oral Dryness

Taste baseline

Taste 2 weeks

Biotene Spray Trial

Participants who received Refresh spray in either the first or second two week trial period of the study.

Refresh Spray Trial

The number of participants in this analysis are lower than the overall population due to missing data.

Taste Alteration/Impairment Due to Oral Dryness

swallowing baseline

swallowing 2 weeks

Swallowing and Chewing Difficulty Due to Oral Dryness

PH baseline

PH 2 weeks

Saliva PH

Difficulty Wearing Dental Prosthesis Score After Biotene Spray

Difficulty Wearing Dental Prosthesis Score After Refresh Spray

No participants in study with dental prosthesis, therefore data was not collected.

Difficulty Wearing Dental Prostheses (if Applicable)

First Wash Out (1 Week)

First Intervention (2 Weeks)

Second Wash Out (1 Week)

Second Intervention (2 Week)

Dimethyl Sulfoxide

60 patients will be randomized to receive adipose-derived allogeneic stem cells

60 patients will receive placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).

Each participant will be double-blindly randomized to receive either adipose-derived allogeneic stem cells or placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).

Stem cells

Placebo

The incidence of head and neck cancer is increasing in the Western World, including Denmark. Cancer of the head and neck and its treatment often have a detrimental and lifelong impact on the quality of life of the patients. Radiotherapy is a key component for approximately 80% of all patients with head and neck cancer and despite the enormous improvement in ionizing radiotherapy, the radiation still leads to significant ionizing of healthy tissue, including the radiation-sensitive salivary glands. Salivary glands suffer severe damage from radiation, and as these cells are the principal sites of fluid secretion one of the most prevalent side effect of irradiation for head and neck cancer is hyposalivation and dry mouth syndrome, xerostomia. Xerostomia leads to debilitating oral disorders and major implication for the overall quality of life, including social life and professional life. Currently, only symptomatic treatment is available to patients suffering from xerostomia, and therefore there is an immense, unmet need for new treatment strategies for hyposalivation and xerostomia.

Stem cells have been identified as a potential treatment modality for a wide variety of disorders by their ability to differentiate into many functional cell types, and stem cells have been suggested as an approach to restoring the function of salivary glands after radiotherapy damage.

The purpose of the study is to assess the efficacy and safety of the injection of stem cells from healthy donors on radiation-induced salivary gland hypofunction and xerostomia in previous head and neck cancer patients. The project can potentially help to develop a clinically relevant treatment option for the growing number of patients suffering from xerostomia after irradiation. The development of new therapies is especially meaningful since only sub-optimal, symptomatic treatments are currently available, and since the symptom of xerostomia immensely reduces quality of life.

The study is a prospective, double-blinded, randomized, placebo-controlled trial

The sponsor, investigators, study staff (except for staff involved in stem cells preparation and staff involved in bioanalytical analyses) and patients will be blinded to treatment assignment and care will be taken to ensure the study team is kept blinded.

Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients

A Single-centre, Double-blinded, Randomised, Placebo-controlled, Phase II Study to Investigate the Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients (MESRIX-III)

Change in salivary gland function measured by a 4 months change in unstimulated whole saliva flow rate in the group receiving ASCs compared with the group of participants receiving placebo (control group receiving injections of CryoStor10 (BiolifeSolutions), the freeze media for ASCs).

Safety evaluated by the incidence of adverse events at four months.

For evaluation of the participants´ perception of xerostomia, the participants will answer validated questionnaires in Danish at baseline and after four months. Patients will fill out EORTC QLQ Module for H\&N-35 (evaluates overall implications of the xerostomia)

For evaluation of the participants´ perception of xerostomia, the participants will answer validated questionnaires in Danish at baseline and after four months. Patients will fill out the Xerostomia Questionnaire (XQ: self reported symptoms)

Change in the composition of saliva after four months by measuring pH.

Change in the composition of saliva after four months by measuring bicarbonate level by ionic balance estimation

Change in the composition of saliva after four months by measuring level of sodium (mmol/L)

Change in the composition of saliva after four months by measuring level of potassium (mmol/L)

Change in the composition of saliva after four months by measuring level of calcium (mmol/L)

Change in the composition of saliva after four months by measuring level of phosphate (mmol/L)

Change in the composition of saliva after four months by measuring level of chloride (mmol/L)

Change in the composition of saliva after four months by measuring level of fluoride (mmol/L)

Change in the composition of saliva after four months by measuring level of total protein (mmol/L)

Change in the composition of saliva after four months by measuring level of fluoride (ppm)

Change in the composition of saliva after four months by measuring level of amylase (U/mL)

Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet

The Cell Therapy Facility, The Blood bank, Dept. of Clinical Immunology, 2034, Rigshospitalet, Denmark

Department of Oncology, 3994, Rigshospitalet, Denmark

Department of Oncology Herlev Hospital, Denmark

Department of Dentistry and Oral Health, Aarhus, Denmark

Rigshospitalet, Denmark

Medical Doctor, investigator

Antineoplastic Agents

Interferons

Interferon-gamma

Antiviral Agents

A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia

Single dose, starting at

* Dose Level 0: 10 x 10\^6 injected into one submandibular gland on Day 1

Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells

Randall J Kimple, MD,PhD

Jacques Galipeau, MD

This is a single center pilot study designed to determine the safety and tolerability of autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12 participants will be enrolled and can expect to be on study for up to 2 years.

Following the completion of screening/baseline procedures, and written consent, eligible participants will undergo bone marrow aspirate in order to obtain MSCs.

The MSC Investigational Medicinal Product (IMP) (dose level 0, n=6, staggered) will be injected into one submandibular gland under local anesthesia, in the gland that received the lowest radiation dose. Patients with only one submandibular gland will be ineligible.

All participants will be called by a study coordinator 3 days (+/- 2 days) after injection to assess pain and will have a phone visit with a physician 1 week (+/- 2 days) after injection during which the investigator will assess pain and ask about the area of injection regarding redness and/or swelling. All participants will complete a pain diary with daily entries over the first month to record the occurrence and severity of pain using a 0-10 visual analog scale and occurrence and severity of other adverse events (e.g., redness, swelling, warmth, tenderness, rash, pruritis, nausea, vomiting, fatigue). Participants will also keep a log of all pain medications taken including both narcotic and non-narcotic medications (e.g. ibuprofen, acetaminophen, etc.) for the first month. Participants will complete 5 follow-up visits over the course of 24 months - at 1, 3, 6, 12, and 24 months following the intervention. Salivary collection for analysis as well as QoL surveys will be obtained at these visits.

Dose Reduction:

* If dose limiting toxicity (DLT) in less than or equal to 1 participant (n=6 participants, staggered at least 14 days), Dose Level 0 will be recommended as starting dose for subsequent trial.
* If DLT in greater than 1 participant, dose level -1 will be administered, staggered at least 14 days in n=6 participants.
* If DLT in this cohort is in less than or equal to 1 participant, Dose Level -1 will be recommended as starting dose for subsequent trial. If DLT in greater than or equal to 2 participants, study will be stopped.

Primary Objective

* To evaluate the safety and tolerability of MSCs for subjects with xerostomia after radiation therapy for HNC.

Secondary Objectives

* To evaluate the efficacy of MSCs for treatment of xerostomia and salivary hypofunction via quality-of-life (QoL) questionnaires, salivary amount, and salivary compositional analysis.
* To assess the imaging characteristics in HNC patients after MSC injection using ultrasound.
* To assess the feasibility of a future Phase 1 dose-escalation study.

single-center, open-label, non-randomized, non-placebo controlled, single-group assignment, pilot study

MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer

Pilot Study of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer

Dose limiting toxicity is defined as: submandibular pain \> 5 on a pain scale of 0-10 at 1-month after MSC injection OR any serious AE OR any of the selected toxicities listed per protocol within one-month post-injection.

Whole saliva production rates will be measured under unstimulated and stimulated saliva collection conditions.

Salivary pH will be measured using a pH meter. The normal range of saliva pH is 6.2-7.6 .

ELISA will be used to quantify total protein concentration in saliva. The normal range of total protein in saliva is 2-5 mg/mL.

The enzyme-linked immunosorbent assay (ELISA) will be used to quantify amylase concentration in saliva. The normal range of amylase concentration in saliva is 10-150 U/mL.

ELISA will be used to quantify mucin concentration in saliva.The normal range of mucin concentration in saliva is 1,000-3,000 ug/mL.

The University of Michigan Xerostomia Related Quality of Life (XeQOL) scale is a validated patient-reported assessment 15 item scale with 4 domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Participants will answer the questions on a scale of 1-5 (not a all, a little, somewhat, quite a bit, very much) for every item. Higher scores represent greater degree of symptoms.

The MDADI is a 20-item questionnaire designed for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer. The MDADI score ranges from 20-100 with a lower scale representing worse dysphagia.

A Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. The VAS xerostomia questionnaire is an 8-item questionnaire that provides a validated measure of the perception of dry mouth. Participants will be asked to mark their responses to each item by placing a vertical line on the 100-mm horizontal scale. The VAS ranges from 8-80 with a lower scale representing less dysphagia/symptoms

Salivary gland size measured by ultrasound imaging

Salivary gland stiffness (fibrosis) will be measured by acoustic radiation force impulse imaging. Evaluators will be blinded to the time point of evaluation (pre- or post- MSC injection)

Study feasibility will in part be measured by participant drop out rate.

University of Wisconsin Carbone Cancer Center (UWCCC)

National Institute of Dental and Craniofacial Research (NIDCR)

University of Wisconsin, Madison

Follow up for serious adverse events continues through 24 months post injection (up to 26 months from participant consent).

A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia

Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells: Single dose, starting at

* Dose Level 0: 10 x 10\^6 injected into one submandibular gland on Day 1

Treatment With MSCs

60-69 years

70-79 years

Age, Customized

Ethnicity (NIH/OMB)

Randy Kimple, MD, PhD, FASTRO

Percentage of Subjects Experiencing Dose Limiting Toxicity (DLT)

Change in Saliva Production Rate

Saliva Composition Analysis: Change in Salivary pH

Saliva Composition Analysis: Change in Total Protein Concentration in Saliva

Saliva Composition Analysis: Change in Amylase Concentration in Saliva

Saliva Composition Analysis: Change in Mucin Concentration in Saliva

Change in The University of Michigan Xerostomia Related Quality of Life (XeQOL) Score

Change in The MD Anderson Dysphagia Index (MDADI) Score

Change in Visual Analogue Scale (VAS) Xerostomia Score

Change in Salivary Gland Size

Change in Salivary Gland Stiffness Measured by Shear Wave Velocity

Participant Drop Out Rate

Overall Study

Symptoms and General Pathology

Facies

The participants will receive 5 x one hour treatment of craniosacral therapy. One treatment per week in five weeks. The treatment will follow the protocol "avenue of expression" end step 2c and 2c in "Ten step protocol" . They will, if possible be instructed in fascial self treatment for maximum 5 minutes a day. Before treatment the participants fulfill the questionnaire " Xerostomia questionnaire after 3 months" - a danish standardized questionnaire of xerostomia used of hospitals. They will fulfill this questionnaire again after ending their 5 treatment sessions, and again 6 months later as a follow up. They will also fulfill a diary with any side effects experienced during the treatment period. I will take their full history the first time we meet I journal my treatment after every treatment session, and journal which effects (positive and negative) the participant has noticed.

Manual treatment of 5 grams on the whole airwaysystem, the throat, the neck, the meninges, the craniel , nerve sleeves, the visceral cranium, the soft tissue in the mouth

cranio sacral therapy

Cathrine T Rahbek, Cst t

The current study aims to assess the efficacy of manual treatment with craniosacral therapy of fascial tissue in throat, neck, cranial and mouth region, on radiation and/ore surgery induced salivary gland hypofunction and xerostomia in patients who have been through surgery and/or radiation therapy because of cancer in to the troat and mouth regions.

The hypothesis of this project is based on a recent clinical case treated by me: I practice as a physiotherapist and craniosacral therapist in a private clinic. The patient in question was treated with craniosacal techniques( techniques that mobilizes the fascia, ment very broad - meninges, dura,sleeves around the nerve-tissue). He suffered from xerostomia and hyposaliva after neck surgery and radiation therapy four years prior to my treatment. During the second treatment of fascial release of the scar tissue and of the tissue around atlas, axis and occiput the patient strongly felt that his saliva started flowing. He received an additional 3 treatments, with fascial release techniques in neck, throat meninges and mouth regions, and three months after his last treatment the patient still reported much better production of saliva than before start of treatment. Furthermore, the patient reported significant gains in ease of speaking and eating. This project aim to assess if this was only an isolated event or if craniosacral therapy could be an evidence based method aiming to increase saliva production and decrease xerostomia for patients after surgical and radiation therapy.

The aim of my project is to examine if craniosacral therapy in chest, throat, necks, cranium and mouth can decrease xerostomia in people who suffers from this after radiation therapy and/ore surgery in neck ore mouth because of cancer in mouth ore throat. If successful, the project will be the first step in developing a clinically relevant treatment option for the growing number of patients suffering from xerostomia after radiotherapy in the throat and mouth area. This is needed, as only sub-optimal symptomatic treatments are currently available and xerostomia has been shown to reduce the quality of life. This study is inspired by a recent Danish project.In this study, stem cell therapy showed clinically significant improvements on both patient-reported measures and measured amount of saliva produced . The authors suggest that the results may be due to a reduction of connective tissue and increased blood flow in the areas affected by radiation therapy. The authors proceed to suggest that hyperbaric oxygen treatment or other treatments attempting to increase blood flow in the radiation-affected areas could be used in combination with stem cell treatment to increase efficiency of the treatment.

The Hypothesis that treatment that increases the blood flow in fibrous tissue damaged after surgery ore radiation has a positive effect on the tissue and the function in its surroundings is echoed in an article about strength and shoulder mobility after breast cancer surgery. its is also recommended that women that have radiation treatment in their breast because of cancer, shall receive instruction in how to treat their radiated tissue manually in the Danish national guidelines for breast cancer. The writers of the two last sources have the hypothesis that manual treatment of fibrous tissue damaged after surgery and radial therapy can prevent tightness in fascia and nerve tissue and preserve a proper function and mobility in shoulder and arm. The writers of the first article claims that the good results after treatment and exercises partly is to the increased blood flow in the area.

A case study with 15 participants that in average 8 years previously has been through surgery ore radial treatment because af cancer and who suffered from dysfagia because of fibrous tissue and neuropathy, showed that the symptoms dysfagia, airway problems and decreased mobility in the neck would be lowered by manual fascial techniques.The effect of any xerostomi was not monitored, but the study that reveals a new way of treat some of the other sequelae fibrous tissue ind mouth and neck can cause, support my hypothesis that manual treatment of fibrous tissue caused of surgery and/or radial therapy can cause increased tissue mobility, nerve conduction, and function in the fibrous tissue.

In my project I will use the treatment protocol "Avenue of expression"and some few steps of the protocol "Ten steps protocol"which addresses the areas I expect to develop fibrous tissue after radial therapy and/ore surgery in neck ore head. The techniques used in these protocols is manual cranio sacral techniques who is light(5 grams) and addresses the fascia in the whole airway system, the neck, the throat, the meninges and nerve sleeves in the cranium, the visceral cranium and the softtissue in the mouth. My rationale in this project is that manual treatment of scar tissue and radiation damaged tissue will increase mobility and blood flow and therefore possibly will increase the production of saliva and decrease the sense of xerostomia.

My project is the very first step into support my hypothesis. If the results of the treatments is promising, its my plan to continue with further research and include a placebo group and a bigger number of participants.

Pilot project - single group intervention with before-after comparisons.

The person who does the statistic will not have participated in the treatments and will not have met the participants.

Does Craniosacraltherapy Have an Effect on Xerostomia and Other Late Sequelae on People Who Has Been Suffering From Cancer in Mouth and Throat?

Does Manuel Treatment With Craniosacral Therapy Change the Experience of Dry Mouth in People Who Suffers With Dry Mouth After Cancer in Throat Ore Mouth - a Pilot Study

The plan is to get the results released as an research article in a profession judged journal. If possible the results will be accessible for everyone who is interested. I will also share it in danish networks for interdisciplinary colleagues, and with relevant patient associations

A Danish questionnaire used to measure xerostomia in patients who have finished their treatment of cancer in head and neck on danish hospital ward

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Blinded Dry Mouth Spray Crossover Study	NCT04608773	Xerostomia Head and Neck C... Xerostomia Foll...	Remineralizing ... Alcohol-Free Mo...	18 Years -	University of Pittsburgh
Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients	NCT04776538	Xerostomia Foll...	Stem cells Placebo	18 Years - 70 Years	Rigshospitalet, Denmark
Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients	NCT04776538	Xerostomia Foll...	Stem cells Placebo	18 Years - 70 Years	Rigshospitalet, Denmark
MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer	NCT04489732	Xerostomia Foll...	Autologous bone...	18 Years - 90 Years	University of Wisconsin, Madison
Does Craniosacraltherapy Have an Effect on Xerostomia and Other Late Sequelae on People Who Has Been Suffering From Cancer in Mouth and Throat?	NCT05882890	Xerostomia Foll... Xerostomia Foll...	cranio sacral t...	18 Years - 81 Years	Rahbek Kraniosakralterapi

Spots Global Cancer Trial Database for xerostomia following radiotherapy