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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 expressionand some few steps of the protocol Ten steps protocolwhich 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.

Official Title
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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

Conditions
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Xerostomia Following Radiotherapy, Xerostomia Following in Neck Ore Head After Cancersurgery

Intervention / Treatment
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* Other: cranio sacral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have finished radiation treatment and/ore surgery for oropharyngeal head ore necḱ cancer at least two years before enrolling the project They shall score at least 4 on an xerostomia numeric scale where 0 is no xerostomia. Exclusion Criteria: Persons who by surgery have got both their submandibular salivaglands removed. Persons with known intercranial aneurism. Persons who have got a skull fracture during the last 6 months. Women who are trying to be pregnant. Persons who have sequela after a trauma on their neck that needed hospitalisation. People with hernia on medulla oblongata. Ill wait to treat people to after one month after their got an eventual dural puncture, ore after 12 weeks of pregnancy. If I during my journal procedure of my participant am finding any signs of active disease, Ill send them to their doctor and do not start my treatment before the doctors approval.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot project - single group intervention with before-after comparisons.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cranoisacraltherapy receivers<br>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. | Other: cranio sacral therapy<br>* 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<br>* Other names: manual fascial treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Xerostomia questionnaire after minimun 3 months | A Danish questionnaire used to measure xerostomia in patients who have finished their treatment of cancer in head and neck on danish hospital ward | Baseline( before start of this study intervention, but at least two yeras after finishing treatment of cancer) | 
| Xerostomia questionnaire after 3 months | A Danish questionnaire used to measure xerostomia in patients who have finished their treatment of cancer in head and neck on danish hospital ward | At the start of fift and last treament. The plan was treatment once a week in five weeks. For 6 persons outcome two was measured the 5. week after start, for 4 the 7. week after start because of two holydaybreaks | 
| Xerostomia questionnaire after 3 months | A Danish questionnaire used to measure xerostomia in patients who have finished their treatment of cancer in head and neck on danish hospital ward | following up 6 months after last treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effect diary | The participants note any side effects during the treatment period | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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craniosacral therapy, manual facial treatment, xerostomia