Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05882890
Enrollment
11
Registered
2023-05-31
Start date
2022-03-18
Completion date
2023-11-27
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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 expressionand a few steps from the protocol Ten steps protocolwhich 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.

Interventions

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.

OTHERExercices Targeting Upper Posture and Respiration

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.

Sponsors

Danish Cancer Society
CollaboratorOTHER
DLHM - Danish Society for Mouth and Throat Cancer
CollaboratorUNKNOWN
Danish Network for Mouth and Throat Cancer
CollaboratorUNKNOWN
Cathrine Rahbek
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

The person who does the statistic analysis will not have participated in the treatments and will not have met the participants.

Intervention model description

Pilot project - single group intervention with before-after comparisons.

Eligibility

Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Xerostomia QuestionnaireBaseline (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.

Secondary

MeasureTime frameDescription
Late Sequelae at BaselinebaselineA 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.
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of TreatmentThe 5. and last time of treatment(intervention of this study)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.
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up6 month after finishng the craniosacral treatment( intervention of this study)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.

Countries

Denmark

Participant flow

Recruitment details

Recruitment is done by sharing information of the project during network events for people who have been through treatment of cancer in mouth, head and/or neck. These events have been arranged by two patient associations -DLHM and Netværket for Hals og Mundhulecancer - two groups organized under the Danish Cancer Society.

Pre-assignment details

No pre-assigment details.

Participants by arm

ArmCount
Craniosacraltherapy Receivers
Receiving 5 treatments of craniosacraltherapy , following the protocol avenue of expression. They are also being instructed in specific exersises
10
Total10

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyExclusion was due to a score in xerostomia VASscale < 4.1

Baseline characteristics

CharacteristicCraniosacraltherapy Receivers
Age, Continuous
Age
65.5 years
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Denmark
10 participants
results of questionaire
Remaining 15 questions overall sum (15 worst-75 best)
46.4 units on a scale
results of questionaire
VAS scale(0=best -10=worst)
8 units on a scale
Sex: Female, Male
Sex
Female
6 Participants
Sex: Female, Male
Sex
Male
4 Participants
time after cancertreatment12.5 years
Type of cancertreatment
laryngeal surgery
2 Participants
Type of cancertreatment
radiation therapy
9 Participants
Type of cancertreatment
surgery in other locations (mouth,ore throat)
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
7 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

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.

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

Population: 11 participants entered the project. 1 participant was not analysed, because of to low score at the xerostomia vas-scale i baseline. The inclusioncriteria for entering the analysis phase of the project was a score at at least 4 n the xerostomia vas-scale

ArmMeasureGroupValue (MEAN)
Craniosacral Therapy ReceiversXerostomia QuestionnaireVAS scale(0best -10 worst)8 score on a scale
Craniosacral Therapy ReceiversXerostomia QuestionnaireRemaining 15 questions overall sum (15 worst-75 best)46.4 score on a scale
Primary

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.

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

Population: 11 participants entered the project. 1 participant was not analysed, because of to low score at the xerostomia vas-scale i baseline. The inclusioncriteria for entering the analysis phase of the project was a score at at least 4 n the xerostomia vas-scale

ArmMeasureGroupValue (MEAN)
Craniosacral Therapy ReceiversXerostomia Questionnairexerostomia VAS scale(= best-10 worst)6.7 Score on a scale
Craniosacral Therapy ReceiversXerostomia Questionnairethe overall sum of the 15 questions questions( 15 worst-75 best)50.12 Score on a scale
Primary

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.

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

Population: 11 participants entered the project. 1 participant was not analysed, because of to low score at the xerostomia vas-scale i baseline. The inclusioncriteria for entering the analysis phase of the project was a score at at least 4 n the xerostomia vas-scale

ArmMeasureGroupValue (MEAN)
Craniosacral Therapy ReceiversXerostomia Questionnairexerostomia VAS scale(0 best -10 worst)7.2 score on a scale
Craniosacral Therapy ReceiversXerostomia Questionnairethe overall score of the 15 questions(15 worst -75 best)49.6 score on a scale
Secondary

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.

Time frame: baseline

Population: 11 participants entered the project. 1 participant was not analysed, because of to low score at the xerostomia vas-scale i baseline. The inclusioncriteria for entering the analysis phase of the project was a score at at least 4 n the xerostomia vas-scale

ArmMeasureGroupValue (NUMBER)
Craniosacral Therapy ReceiversLate Sequelae at Baselinedry mouth10 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselineobstipation2 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinelymphedema3 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinetinnitus3 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinedifficulty swallowing7 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinetense/stiff neck5 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselineproblems with respiration6 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinestiff jaw5 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinedifficulty with speaking3 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinefatigue3 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinedifficulty sleeping3 participants
Craniosacral Therapy ReceiversLate Sequelae at Baselinepain1 participants
Secondary

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.

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

Population: 11 participants entered the project. 1 participant was not analysed, because of to low score at the xerostomia vas-scale i baseline. The inclusioncriteria for entering the analysis phase of the project was a score at at least 4 n the xerostomia vas-scale

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-updry mouth0 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-upobstipation1 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-uplymphedema0 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-uptinnitus0 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-updifficulty swallowing1 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-uptense/stiff neck2 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-upproblems with respiration4 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-upstiff jaw0 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-updifficulty with speaking0 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-upfatigue1 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-updifficulty sleeping0 Participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-uppain1 Participants
Secondary

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.

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

Population: 11 participants entered the project. 1 participant was not analysed, because of to low score at the xerostomia vas-scale i baseline. The inclusioncriteria for entering the analysis phase of the project was a score at at least 4 n the xerostomia vas-scale

ArmMeasureGroupValue (NUMBER)
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentdry mouth2 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentobstipation2 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentlymphedema0 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmenttinnitus0 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentdifficulty swallowing1 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmenttense/stiff neck3 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentproblems with respiration4 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentstiff jaw0 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentdifficulty with speaking0 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentfatigue1 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentdifficulty sleeping2 participants
Craniosacral Therapy ReceiversNumber of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatmentpain0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026