Xerostomia Following RadiotherapyNCT05882890
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?
A study testing Craniosacral Therapy and Exercices Targeting Upper Posture and Respiration in people with Xerostomia Following Radiotherapy and Xerostomia Following in Neck or Head After Cancer Surgery, run by Cathrine Rahbek at 2 sites in Denmark.
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/or surgery-induced salivary gland hypofunction and xerostomia in patients who have received surgery and/or radiation therapy because of cancer in the… Read more about this study
- Who is it for?
- Ages 18 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Xerostomia Following Radiotherapy, Xerostomia Following in Neck or Head After Cancer Surgery, Other Late Sequelae Following Radiotherapy and Cancer Surgery in Neck or Head
- What is being tested?
- Craniosacral Therapy and Exercices Targeting Upper Posture and Respiration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesDenmark
- Study dates
- 18 Mar 2022to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Center for Kræft og Sundhed
Copenhagen, 2200
- Rahbek kraniosakralterapi -FysioDanmark Skødstrup
Skødstrup, Århus, 8530
About this study
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
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.
Read the detailed description
The aim of my project is to examine if craniosacral therapy in chest, throat, neck, cranium and mouth can decrease xerostomia in people who suffer from this after radiation therapy and/or surgery in neck or mouth because of cancer in mouth or 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 the 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 achieve a synergistic effect.
The hypothesis that treatment that increases the blood flow in fibrous tissue damaged after surgery or radiation has a positive effect on the tissue and its associated physiologic functions is echoed in an article about strength and shoulder mobility after breast cancer surgery. In the Danish national guidelines for breast cancer, it is also recommended that women that receive radiation therapy for their breasts because of cancer, shall receive instruction in how to treat their radiated tissue manually. The writers of the two last sources hypothesize 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 is partly attributable to the increased blood flow in the area.
A case study with 15 participants that in average 8 years previously has been through surgery or radial treatment because af cancer and who suffered from dysphagia because of fibrous tissue and neuropathy, showed that the symptoms dysphagia, airway problems and decreased mobility in the neck would be lowered by manual fascial techniques.The effect of any xerostomia was not monitored, but the study that reveals a new way to 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 a few steps from the protocol "Ten steps protocol"which addresses the areas I expect to develop fibrous tissue after radial therapy and/or surgery in neck or head. The techniques used in these protocols is light (5 grams) manual craniosacral techniques, addressing the fascia in the airway system, the neck, the throat, the meninges and nerve sleeves in the cranium, the visceral cranium, and the soft tissue in the mouth. My rationale in this project is that manual treatment of scar tissue and tissue damaged by radiation will increase mobility and blood flow and therefore possibly increase the production of saliva and decrease the sense of xerostomia.
The manual treatment is combined with home exercises that targets posture in upper body and respiration. This for maintaining the effects of the manual treatment.
Second purpose of the project is to examine if the intervention has any effect on other well-known late sequelae after treatment of cancer in mouth and neck.
Outcome is measured by a xerostomia questionaire inspired by the one used in "efficacy of the bioextra dry mouth care system in the treatment of radiotherapy induced xerostomia by Dirix P. Etal, and by selfreporting. "
My project is the very first step into supporting my hypothesis. If the results of the treatments are promising, it is my plan to continue with further research and include a placebo group and a larger sample of participants.
- 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
- Being tested
- Craniosacral Therapy, Exercices Targeting Upper Posture and Respiration
- Keywords
- craniosacral therapy, manual fascial treatment, xerostomia, late sequelae of cancer, exercises targeting posture in upper body and respiration
- Medical subject headings
- Xerostomia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniosacral TherapyOther
Also called Manual Fascial Treatment
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.
Exercices Targeting Upper Posture and RespirationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Craniosacral Therapy; Other: Exercices Targeting Upper Posture and Respiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months post after finishing the craniosacral treatment (the intervention in this study)
Secondary outcomes (3)
Late Sequelae at Baseline
A history is taken before the first treatment, where I asked if the participant suffered from 11 other well-known late seguela in this patient group.
I asked for:
dry mouth obstipation lymphedema tinnitus difficulty swallowing tense/stiff neck problems with respiration stiff jaw difficulty with speaking fatigue difficulty sleeping pain
This is noted in their patient-record. Following is the number of participants who report suffering from a particular late sequelae.
Measured: baseline
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment
A history is taken before the first treatment, where I asked if the participant suffered from 11 other well-known late sequela. At the 5. and last treatment I asked then if they observed any changes in their late seguela (better or worse) - They did not report any worsening of their late sequela, but a number of participants reported some positive changes.The selfreported change in symptoms is noted in their patient record. The following is the number of participants, who observed a positive change( a decrease in symptoms) in their late sequeale.
Measured: 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
A history was taken before the first treatment, where I asked if the participant suffered from 11 other well-known late sequelae in this patient group. The 5. time and 6 months after end of treatment, I asked if they observed any differences (better or worse) with their late sequelae an noted it down in their patientrecord.. They have not reported any worsening of late sequela - the following is the number of participants who reported a possitive change (a decrease in symptomps) in their late sequela at 6 month following.
Measured: 6 month after finishng the craniosacral treatment( intervention of this study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start18 Mar 2022
- Primary completion20 Jan 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Xerostomia Following RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot project - single group intervention with before-after comparisons.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathrine Rahbek
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, DLHM - Danish Society for Mouth and Throat Cancer, Danish Network for Mouth and Throat Cancer
- Responsible party
- Sponsor-investigator, Cathrine Rahbek, Rahbek Kraniosakralterapi
- Investigators
- Cathrine T Rahbek, Cst t, Principal investigator, Rahbek KST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882890
- Sponsor's protocol ID
- RahbekKST-PILOT
- Status last verified
- Jun 2026
- First submitted
- 4 Oct 2021
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to get the results released as an research article Upledger Institute Internationals research database. The results will be accessible for everyone who is interested. I will also share it in Danish networks for interdisciplinary colleagues, and with relevant patient associations
Publications
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.
PubMed 28431302Gronhoj 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.
PubMed 29678523Lauridsen 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.
PubMed 14731584Dirix 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.
PubMed 17235501
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05882890
- Acronym / sponsor ID
- RahbekKST-PILOT
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cathrine RahbekUniversity, hospital or other
- Collaborators
- Danish Cancer Society, DLHM - Danish Society for Mouth and Throat Cancer, Danish Network for Mouth and Throat Cancer
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of my project is to examine if craniosacral therapy in chest, throat, neck, cranium and mouth can decrease xerostomia in people who suffer from this after radiation therapy and/or surgery in neck or mouth because of cancer in mouth or 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 the 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 achieve a synergistic effect.
The hypothesis that treatment that increases the blood flow in fibrous tissue damaged after surgery or radiation has a positive effect on the tissue and its associated physiologic functions is echoed in an article about strength and shoulder mobility after breast cancer surgery. In the Danish national guidelines for breast cancer, it is also recommended that women that receive radiation therapy for their breasts because of cancer, shall receive instruction in how to treat their radiated tissue manually. The writers of the two last sources hypothesize 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 is partly attributable to the increased blood flow in the area.
A case study with 15 participants that in average 8 years previously has been through surgery or radial treatment because af cancer and who suffered from dysphagia because of fibrous tissue and neuropathy, showed that the symptoms dysphagia, airway problems and decreased mobility in the neck would be lowered by manual fascial techniques.The effect of any xerostomia was not monitored, but the study that reveals a new way to 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 a few steps from the protocol "Ten steps protocol"which addresses the areas I expect to develop fibrous tissue after radial therapy and/or surgery in neck or head. The techniques used in these protocols is light (5 grams) manual craniosacral techniques, addressing the fascia in the airway system, the neck, the throat, the meninges and nerve sleeves in the cranium, the visceral cranium, and the soft tissue in the mouth. My rationale in this project is that manual treatment of scar tissue and tissue damaged by radiation will increase mobility and blood flow and therefore possibly increase the production of saliva and decrease the sense of xerostomia.
The manual treatment is combined with home exercises that targets posture in upper body and respiration. This for maintaining the effects of the manual treatment.
Second purpose of the project is to examine if the intervention has any effect on other well-known late sequelae after treatment of cancer in mouth and neck.
Outcome is measured by a xerostomia questionaire inspired by the one used in "efficacy of the bioextra dry mouth care system in the treatment of radiotherapy induced xerostomia by Dirix P. Etal, and by selfreporting. "
My project is the very first step into supporting my hypothesis. If the results of the treatments are promising, it is my plan to continue with further research and include a placebo group and a larger sample of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot project - single group intervention with before-after comparisons.
| Arm | Type | Receives |
|---|---|---|
| Cranoisacral Therapy Receivers | Experimental | Other: Craniosacral Therapy, Other: Exercices Targeting Upper Posture and RespirationThe 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. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Craniosacral TherapyAlso: Manual Fascial TreatmentManual 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. | Other | Cranoisacral Therapy Receivers |
| Exercices Targeting Upper Posture and RespirationExercises 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. | Other | Cranoisacral Therapy Receivers |
Primary outcome
Xerostomia Questionnaire
Time frame: Baseline (before start of this study intervention, but at least two years after finishing treatment of cancer)
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.
Xerostomia Questionnaire
Time frame: At the start of the fifth and last treament (intervention of this study). .
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.
Xerostomia Questionnaire
Time frame: 6 months post after finishing the craniosacral treatment (the intervention in this study)
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.
3 secondary outcomes
Late Sequelae at Baseline
Time frame: baseline
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment
Time frame: 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
Time frame: 6 month after finishng the craniosacral treatment( intervention of this study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28431302Hoxbroe 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.
- Background: PubMed 29678523Gronhoj 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.
- Background: PubMed 14731584Lauridsen 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.
- Background: PubMed 17235501Dirix 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.
- National Clinical Guideline for Consequences After Surgery for Breast CancerLink provided by the sponsor.
- The Role of Myofascial and Manual Therapy in Dysphagia TreatmentLink provided by the sponsor.
- Article based on this reseach: Can Late Effects After Treatment for Throat and Oral Cavity Cancer Be Reduced with CranioSacral Therapy? Experiences and Considerations in Treating Late Effects with CranioSacral Therapy - A Guide for ProfessionalsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan is to get the results released as an research article Upledger Institute Internationals research database. The results will be accessible for everyone who is interested. I will also share it in Danish networks for interdisciplinary colleagues, and with relevant patient associations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathrine T Rahbek, Cst t principal investigator
Rahbek KST
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Craniosacral Therapy and Exercices Targeting Upper Posture and Respiration in people with Xerostomia Following Radiotherapy and Xerostomia Following in Neck or Head After Cancer Surgery, run by Cathrine Rahbek at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerostomia Questionnaire (time frame: Baseline (before start of this study intervention, but at least two years after finishing treatment of cancer)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882890, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.