Trial Outcomes & Findings for 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? (NCT NCT05882890)

Last Updated: 2025-05-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

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

Results posted on

2025-05-14

Participant Flow

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.

No pre-assigment details.

Participant milestones

Participant milestones
Measure	Craniosacraltherapy Receivers The participants will receive 50 minutes of craniosacral therapy weekly for five weeks.The treatment will follow the protocol "avenue of expression" and step 2c and 2c in "Ten step protocol" . They will get instructions in exercises targeting the upper posture and respiration to do at home between treatments. Before treatment the participants fill in the questionnaire " Xerostomia questionnaire after 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 follow up. They will also fill in a diary with any side effects experienced during the treatment period. I will take their full history the first time we meet, I journal my treatment after every treatment session, and journal which effects (positive and negative) the participant has noticed. Craniosacral therapy: Manual treatment on the whole airway system, the throat, the neck, the meninges, the cranium, nerve sleeves, the visceral cranium, and the soft tissue in the mouth. Exercises - targeting the upper posture and respiration.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Craniosacraltherapy Receivers The participants will receive 50 minutes of craniosacral therapy weekly for five weeks.The treatment will follow the protocol "avenue of expression" and step 2c and 2c in "Ten step protocol" . They will get instructions in exercises targeting the upper posture and respiration to do at home between treatments. Before treatment the participants fill in the questionnaire " Xerostomia questionnaire after 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 follow up. They will also fill in a diary with any side effects experienced during the treatment period. I will take their full history the first time we meet, I journal my treatment after every treatment session, and journal which effects (positive and negative) the participant has noticed. Craniosacral therapy: Manual treatment on the whole airway system, the throat, the neck, the meninges, the cranium, nerve sleeves, the visceral cranium, and the soft tissue in the mouth. Exercises - targeting the upper posture and respiration.
Overall Study Exclusion was due to a score in xerostomia VASscale < 4.	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Craniosacraltherapy Receivers n=10 Participants Receiving 5 treatments of craniosacraltherapy , following the protocol " avenue of expression". They are also being instructed in specific exersises
Age, Continuous Age	65.5 years n=10 Participants
Sex: Female, Male Sex · Female	6 Participants n=10 Participants
Sex: Female, Male Sex · Male	4 Participants n=10 Participants
Region of Enrollment Denmark	10 participants n=10 Participants
results of questionaire VAS scale(0=best -10=worst)	8 units on a scale n=10 Participants
results of questionaire Remaining 15 questions overall sum (15 worst-75 best)	46.4 units on a scale n=10 Participants
time after cancertreatment	12.5 years n=10 Participants
Type of cancertreatment laryngeal surgery	2 Participants n=10 Participants
Type of cancertreatment surgery in other locations (mouth,ore throat)	6 Participants n=10 Participants
Type of cancertreatment radiation therapy	9 Participants n=10 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Craniosacral Therapy Receivers n=10 Participants Please refer to baseline characteristics
Xerostomia Questionnaire VAS scale(0best -10 worst)	8 score on a scale Interval 6.0 to 10.0
Xerostomia Questionnaire Remaining 15 questions overall sum (15 worst-75 best)	46.4 score on a scale Interval 30.0 to 65.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Craniosacral Therapy Receivers n=10 Participants Please refer to baseline characteristics
Xerostomia Questionnaire xerostomia VAS scale(= best-10 worst)	6.7 Score on a scale Interval 3.0 to 10.0
Xerostomia Questionnaire the overall sum of the 15 questions questions( 15 worst-75 best)	50.12 Score on a scale Interval 35.0 to 69.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Craniosacral Therapy Receivers n=10 Participants Please refer to baseline characteristics
Xerostomia Questionnaire xerostomia VAS scale(0 best -10 worst)	7.2 score on a scale Interval 5.0 to 10.0
Xerostomia Questionnaire the overall score of the 15 questions(15 worst -75 best)	49.6 score on a scale Interval 30.0 to 64.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Craniosacral Therapy Receivers n=10 Participants Please refer to baseline characteristics
Late Sequelae at Baseline tinnitus	3 participants
Late Sequelae at Baseline difficulty swallowing	7 participants
Late Sequelae at Baseline tense/stiff neck	5 participants
Late Sequelae at Baseline problems with respiration	6 participants
Late Sequelae at Baseline dry mouth	10 participants
Late Sequelae at Baseline obstipation	2 participants
Late Sequelae at Baseline lymphedema	3 participants
Late Sequelae at Baseline stiff jaw	5 participants
Late Sequelae at Baseline difficulty with speaking	3 participants
Late Sequelae at Baseline fatigue	3 participants
Late Sequelae at Baseline difficulty sleeping	3 participants
Late Sequelae at Baseline pain	1 participants

SECONDARY outcome

Timeframe: The 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.

Outcome measures

Outcome measures
Measure	Craniosacral Therapy Receivers n=10 Participants Please refer to baseline characteristics
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment dry mouth	2 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment obstipation	2 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment lymphedema	0 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment tinnitus	0 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment difficulty swallowing	1 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment tense/stiff neck	3 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment problems with respiration	4 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment stiff jaw	0 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment difficulty with speaking	0 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment fatigue	1 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment difficulty sleeping	2 participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment pain	0 participants

SECONDARY outcome

Timeframe: 6 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.

Outcome measures

Outcome measures
Measure	Craniosacral Therapy Receivers n=10 Participants Please refer to baseline characteristics
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up tense/stiff neck	2 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up problems with respiration	4 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up stiff jaw	0 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up difficulty with speaking	0 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up fatigue	1 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up difficulty sleeping	0 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up pain	1 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up dry mouth	0 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up obstipation	1 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up lymphedema	0 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up tinnitus	0 Participants
Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up difficulty swallowing	1 Participants

Adverse Events

Cranoisacraltherapy Receivers

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cranoisacraltherapy Receivers n=10 participants at risk receivers of cranoisacral therapy and home exercises
General disorders dizziness	30.0% 3/10 • Number of events 4 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders irritability	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders headache	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders sore neck /upper back	20.0% 2/10 • Number of events 2 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders cramp in the neck	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders sore floor of mouth	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders more dislocation of the jaw than usual	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders tight jaws	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders difficulty controlling the tongue	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders reactions on the ears	20.0% 2/10 • Number of events 2 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders runny nose	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders more coughing and secretion than usual	10.0% 1/10 • Number of events 2 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders a feeling of pressure in the chest (not angina pectoris)	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders more thirst	10.0% 1/10 • Number of events 2 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
Gastrointestinal disorders more hungry	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders stomach ache/frequent visits to the toilet	20.0% 2/10 • Number of events 2 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders need to pee more	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders feeling bloated	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders feeling tired	30.0% 3/10 • Number of events 4 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders cramp in the feet	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.
General disorders restlessness in the body	10.0% 1/10 • Number of events 1 • 5 weeks. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up. Diary, asking about adverse events at every treatment. There has not been asked for adverse events after end of treatment and there has not been reported any (through spontaneous reports while going over the trial with all participants) at 6 months follow up.

Additional Information

Cathrine Rahbek

Rahbek FYS

Phone: 0045 30645390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place