N/A
N=11
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?
Xerostomia Following Radiotherapy · Xerostomia Following in Neck or Head After Cancer Surgery · Other Late Sequelae Following Radiotherapy and Cancer Surgery in Neck or Head
Bottom Line
View on ClinicalTrials.gov: NCT05882890 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Xerostomia Questionnaire — 8; 46.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Craniosacral Therapy (Other); Exercices Targeting Upper Posture and Respiration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cathrine Rahbek
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Xerostomia Questionnaire |
7.2; 49.6 | — |
| PRIMARY Xerostomia Questionnaire |
7.2; 49.6 | — |
| PRIMARY Xerostomia Questionnaire |
7.2; 49.6 | — |
| SECONDARY Late Sequelae at Baseline |
10; 2; 3; 3; 7; 5 | — |
| SECONDARY Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment |
2; 2; 0; 0; 1; 3 | — |
| SECONDARY Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up |
0; 1; 0; 0; 1; 2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05882890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.