Clinical trial · Interventional
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?
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Other Late Sequelae Following Radiotherapy and Cancer Surgery in Neck or Head | — | UNRESOLVED | — |
| Xerostomia Following in Neck or Head After Cancer Surgery | — | UNRESOLVED | — |
| Xerostomia Following Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Craniosacral Therapy | Other | — | UNRESOLVED |
| Exercices Targeting Upper Posture and Respiration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cranoisacral Therapy Receivers
- description
- 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.
- interventionNames
- Other: Craniosacral Therapy
- Other: Exercices Targeting Upper Posture and Respiration
Primary outcomes (3)
- measure
- Xerostomia Questionnaire
- timeFrame
- Baseline (before start of this study intervention, but at least two years after finishing treatment of cancer)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 81 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (4)
- BACKGROUNDHoxbroe 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
- BACKGROUNDGronhoj 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
- BACKGROUNDLauridsen 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
- BACKGROUNDDirix 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