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

Xerostomia Following Radiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05882890
• Other study ID #: RahbekKST-PILOT
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: May 2023
• Source: Rahbek Kraniosakralterapi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: August 1, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 81 Years

Eligibility

Inclusion Criteria:

• Have finished radiation treatment and/ore surgery for oropharyngeal head ore nec? 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.

Related Conditions & MeSH terms

• Xerostomia
• Xerostomia Following Radiotherapy

Intervention

Other:
• cranio sacral therapy
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

Locations

Country	Name	City	State
Denmark	Center for Kræft og Sundhed	København
Denmark	- Rahbek kraniosakralterapi -FysioDanmark Skødstrup	Skødstrup	Århus

Sponsors (4)

Lead Sponsor	Collaborator
Cathrine Rahbek	Danish Cancer Society, Danish Network for Mouth and Throat Cancer, DLHM - Danish Society for Mouth and Throat Cancer

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Gronhoj C, Jensen DH, Vester-Glowinski P, Jensen SB, Bardow A, Oliveri RS, Fog LM, Specht L, Thomsen C, Darkner S, Jensen M, Muller V, Kiss K, Agander T, Andersen E, Fischer-Nielsen A, von Buchwald C. Safety and Efficacy of Mesenchymal Stem Cells for Radiation-Induced Xerostomia: A Randomized, Placebo-Controlled Phase 1/2 Trial (MESRIX). Int J Radiat Oncol Biol Phys. 2018 Jul 1;101(3):581-592. doi: 10.1016/j.ijrobp.2018.02.034. Epub 2018 Mar 6. — View Citation

Hoxbroe Michaelsen S, Gronhoj C, Hoxbroe Michaelsen J, Friborg J, von Buchwald C. Quality of life in survivors of oropharyngeal cancer: A systematic review and meta-analysis of 1366 patients. Eur J Cancer. 2017 Jun;78:91-102. doi: 10.1016/j.ejca.2017.03.006. Epub 2017 Apr 18. — View Citation

Lauridsen MC, Torsleff KR, Husted H, Erichsen C. Physiotherapy treatment of late symptoms following surgical treatment of breast cancer. Breast. 2000 Feb;9(1):45-51. doi: 10.1054/brst.1999.0087. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	side effect diary	The participants note any side effects during the treatment period	5 weeks

External Links

•   national clinical guideline for consequences after surgery for breastcancer
•   the role of myofascial and menual therapy in dysphagia treatment