Does Craniosacraltherapy Combined With Exercises That Focuses om Respiration and Posture in the Upper Body Have an Effect on Xerostomia and Other Late Sequelae on People Who Has Been Suffering From Cancer in Mouth and Throat?

NCT05882890 | Completed Results

• 1 other identifier: RahbekKST-PILOT
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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/or surgery-induced salivary gland hypofunction and xerostomia in patients who have received surgery and/or radiation therapy because of cancer in the throat 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 craniosarcal techniques (techniques that, in a broad sense, mobilizes the fascia, including meninges, dura, sleeves around the nerve-tissue etc.). 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 to increase saliva production and decrease xerostomia for patients after surgical and radiation therapy.

Conditions

Xerostomia Following Radiotherapy; Xerostomia Following in Neck or Head After Cancer Surgery; Other Late Sequelae Following Radiotherapy and Cancer Surgery in Neck or Head

Keywords

craniosacral therapy; manual fascial treatment; xerostomia; late sequelae of cancer; exercises targeting posture in upper body and respiration

Outcome Measures

Primary Outcomes (3)

• Xerostomia Questionnaire

  A Danish questionnaire for following up on patients who have finished their cancer treatment in head and neck on a Danish hospital. It is used at least 3 months after treatment. The participants in this study has finished their treatment for cancer at least two years from enroling this study. VAS xerostomia scale0-10 (10 is worst) The remaining 14 questions were phrased "how much does \[question subject\] bother you:" (translated from Danish) not at all (1) - a little (2) - some (3) a lot (4) very much( 5) The final question(number 15) were: "How would you feel, if you had to live the rest of your life, with the symptoms you have now?:" enjoyable(1), very satisfied (2) neither satisfied ore unsatisfied(3), very unsatisfied(4), terrible(5) the sum of points from the 15 questions gives an overall score.

  Baseline (before start of this study intervention, but at least two years after finishing treatment of cancer)

• Xerostomia Questionnaire

  A Danish questionnaire for following up on patients who have finished their cancer treatment in head and neck on a Danish hospital. It is used at least 3 months after treatment. The participants in this study has finished their treatment for cancer at least two years from enroling this study. VAS xerostomia scale0-10 (10 is worst) The remaining 14 questions were phrased "how much does \[question subject\] bother you:" (translated from Danish) not at all (1) - a little (2) - some (3) a lot (4) very much( 5) The final question(number 15) were: "How would you feel, if you had to live the rest of your life, with the symptoms you have now?:" enjoyable(1), very satisfied (2) neither satisfied ore unsatisfied(3), very unsatisfied(4), terrible(5) The sum of points from the 15 questions gives an overall score.

  At the start of the fifth and last treament (intervention of this study). .

• Xerostomia Questionnaire

  A Danish questionnaire for following up on patients who have finished their cancer treatment in head and neck on a Danish hospital. It is used at least 3 months after treatment. The participants in this study has finished their treatment for cancer at least two years from enroling this study. VAS xerostomia scale0-10 (10 is worst) The remaining 14 questions were phrased "how much does \[question subject\] bother you:" (translated from Danish) not at all (1) - a little (2) - some (3) a lot (4) very much( 5) The final question(number 15) were: "How would you feel, if you had to live the rest of your life, with the symptoms you have now?:" enjoyable(1), very satisfied (2) neither satisfied ore unsatisfied(3), very unsatisfied(4), terrible(5) The sum of points from the 15 questions gives an overall score.

  6 months post after finishing the craniosacral treatment (the intervention in this study)

Secondary Outcomes (3)

• Late Sequelae at Baseline

  baseline

• Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment

  The 5. and last time of treatment(intervention of this study)

• Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up

  6 month after finishng the craniosacral treatment( intervention of this study)

Study Arms (1)

Cranoisacral Therapy Receivers

EXPERIMENTAL

The participants will receive 50 minutes of treatment of craniosacral therapy once a week in 5 weeks. The treatment will follow the protocol "avenue of expression" end step 2c and 2c in "Ten step protocol". Instructions in home exercises is given. Before treatment the participants fill in the questionnaire "Xerostomia questionnaire after min 3 months" - a Danish standardized questionnaire of xerostomia used in hospitals. They will fill in this questionnaire again after ending their 5 treatment sessions, and again 6 months later as a follow up. They will also take notes in a diary of any side effects experienced during the treatment period. I will take their full medical history the first time we meet, I will take notes describing my treatment after every treatment session, including notes of the effects (positive and negative) that the participant has noticed.

Other: Craniosacral Therapy; Other: Exercices Targeting Upper Posture and Respiration

Interventions

Craniosacral Therapy OTHER

Manual treatment, 5 grams, on the airway system, the throat, the neck, the meninges, the cranial nerve sleeves, the visceral cranium, and the soft tissue in the mouth.

Also known as: Manual Fascial Treatment

Cranoisacral Therapy Receivers

Exercices Targeting Upper Posture and Respiration OTHER

Exercises targeting upper posture and breathing exercises. The exercises is given when the therapist has reached some anatomical milestones in the treatment protocol. For example, an exercise with diaphragmatic breathing is given after manual treatment of diaphragma.

Cranoisacral Therapy Receivers

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have finished radiation treatment and/or surgery for oro-pharyngeal head or 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.

You may not qualify if:

• Persons who by surgery have got both their submandibular saliva glands removed.
• Persons with known intercranial aneurism.
• Persons who have got a skull fracture during the last 6 months.
• Women who are trying to get pregnant.
• Persons who have sequela after a trauma on their neck that needed hospitalization.
• People with hernia on medulla oblongata.
• I will wait to treat people until after one month after they have received any dural puncture, or after 12 weeks of pregnancy.
• If I during my journal procedure of my participant finds any signs of active disease, I will send them to their doctor and do not start my treatment before the doctors approval.

Sponsors & Collaborators

• Cathrine Rahbek: lead
• Danish Cancer Society: collaborator
• DLHM - Danish Society for Mouth and Throat Cancer: collaborator
• Danish Network for Mouth and Throat Cancer: collaborator

Study Sites (2)

Center for Kræft og Sundhed

Copenhagen, 2200, Denmark

Location

- Rahbek kraniosakralterapi -FysioDanmark Skødstrup

Skødstrup, Århus, 8530, Denmark

Location

Related Publications (4)

• 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.

  PMID: 28431302 BACKGROUND

• 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.

  PMID: 29678523 BACKGROUND

• 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.

  PMID: 14731584 BACKGROUND

• Dirix P, Nuyts S, Vander Poorten V, Delaere P, Van den Bogaert W. Efficacy of the BioXtra dry mouth care system in the treatment of radiotherapy-induced xerostomia. Support Care Cancer. 2007 Dec;15(12):1429-36. doi: 10.1007/s00520-006-0210-y. Epub 2007 Jan 18.

  PMID: 17235501 BACKGROUND

Related Links

• National Clinical Guideline for Consequences After Surgery for Breast Cancer
• The Role of Myofascial and Manual Therapy in Dysphagia Treatment

MeSH Terms

Conditions

Xerostomia; Respiratory Aspiration

Interventions

Respiration

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Limitations and Caveats

1 participant received intervention, but was excluded before analysis because it was discovered afterwards that this participant was never eligible for inclusion (because of low score (3) in the xerostomia vas-scale at baseline - inclusion criterium was \>= 4) While scoring the xerostomia questionnaire 6 answers have inconclusive scores (either two values, or no values at all). These cases were not included when calculating the mean.

Results Point of Contact

• Title: Cathrine Rahbek
• Organization: Rahbek FYS

cathrinerahbek@outlook.dk

0045 30645390

Study Officials

• Cathrine T Rahbek, Cst t

  Rahbek KST

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The person who does the statistic analysis will not have participated in the treatments and will not have met the participants.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physio Therapist, Craniotherapist cst t

Model Details: Pilot project - single group intervention with before-after comparisons.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: May 31, 2023
• Study Start: March 18, 2022
• Primary Completion: January 20, 2023
• Study Completion: November 27, 2023
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: I will keep the data at my desktop for at least 10 years
• Access Criteria: They will be in Danish and will not be on a website - i will translate them if you contact me on my mail address.

Locations

DK (2)