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

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

NCT ID: NCT05882890

Condition: Xerostomia Following Radiotherapy
Xerostomia Following in Neck Ore Head After Cancersurgery

Conditions: Official terms:
Xerostomia

Conditions: Keywords:
craniosacral therapy
manual facial treatment
xerostomia

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Pilot project - single group intervention with before-after comparisons.

Primary purpose: Treatment

Masking: None (Open Label)

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

Intervention:

Intervention type: Other
Intervention name: cranio sacral therapy
Description: 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
Arm group label: cranoisacraltherapy receivers

Other name: manual fascial treatment

Summary: 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: 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 81 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Center for Kræft og Sundhed

Address:
City: København
Zip: 2200
Country: Denmark

Facility:
Name: - Rahbek kraniosakralterapi -FysioDanmark Skødstrup

Address:
City: Skødstrup
Zip: 8530
Country: Denmark

Start date: March 18, 2022

Completion date: August 1, 2023

Lead sponsor:
Agency: Cathrine Rahbek
Agency class: Other

Collaborator:
Agency: Danish Cancer Society
Agency class: Other

Collaborator:
Agency: DLHM - Danish Society for Mouth and Throat Cancer
Agency class: Other

Collaborator:
Agency: Danish Network for Mouth and Throat Cancer
Agency class: Other

Source: Rahbek Kraniosakralterapi

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05882890
https://www.fysio.dk/globalassets/documents/fafo/kliniske-retningslinjer/onkologi/nkr_brystkraeft_2015.pdf
https://dysphagiacafe.com/2018/04/22/the-role-of-myofascial-release-and-manual-therapy-in-dysphagia-treatment/