Xerostomia Following Radiotherapy, Xerostomia Following in Neck or Head After Cancer Surgery, Other Late Sequelae Following Radiotherapy and Cancer Surgery in Neck or Head
Conditions
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.
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Xerostomia Questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Sequelae at Baseline | 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. |
| Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | 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. |
| Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | 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. |
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
| Arm | Count |
|---|---|
| Craniosacraltherapy Receivers Receiving 5 treatments of craniosacraltherapy , following the protocol avenue of expression. They are also being instructed in specific exersises | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Exclusion was due to a score in xerostomia VASscale < 4. | 1 |
Baseline characteristics
| Characteristic | Craniosacraltherapy 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 cancertreatment | 12.5 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 type | EG000 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
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Craniosacral Therapy Receivers | Xerostomia Questionnaire | VAS scale(0best -10 worst) | 8 score on a scale |
| Craniosacral Therapy Receivers | Xerostomia Questionnaire | Remaining 15 questions overall sum (15 worst-75 best) | 46.4 score on a scale |
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Craniosacral Therapy Receivers | Xerostomia Questionnaire | xerostomia VAS scale(= best-10 worst) | 6.7 Score on a scale |
| Craniosacral Therapy Receivers | Xerostomia Questionnaire | the overall sum of the 15 questions questions( 15 worst-75 best) | 50.12 Score on a scale |
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Craniosacral Therapy Receivers | Xerostomia Questionnaire | xerostomia VAS scale(0 best -10 worst) | 7.2 score on a scale |
| Craniosacral Therapy Receivers | Xerostomia Questionnaire | the overall score of the 15 questions(15 worst -75 best) | 49.6 score on a scale |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | dry mouth | 10 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | obstipation | 2 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | lymphedema | 3 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | tinnitus | 3 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | difficulty swallowing | 7 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | tense/stiff neck | 5 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | problems with respiration | 6 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | stiff jaw | 5 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | difficulty with speaking | 3 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | fatigue | 3 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | difficulty sleeping | 3 participants |
| Craniosacral Therapy Receivers | Late Sequelae at Baseline | pain | 1 participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | dry mouth | 0 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | obstipation | 1 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | lymphedema | 0 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | tinnitus | 0 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | difficulty swallowing | 1 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | tense/stiff neck | 2 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | problems with respiration | 4 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | stiff jaw | 0 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | difficulty with speaking | 0 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | fatigue | 1 Participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela at 6 Month Follow-up | difficulty sleeping | 0 Participants |
| Craniosacral Therapy Receivers | 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 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | dry mouth | 2 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | obstipation | 2 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | lymphedema | 0 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | tinnitus | 0 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | difficulty swallowing | 1 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | tense/stiff neck | 3 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | problems with respiration | 4 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | stiff jaw | 0 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | difficulty with speaking | 0 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | fatigue | 1 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | difficulty sleeping | 2 participants |
| Craniosacral Therapy Receivers | Number of Partcipants Who Experienced a Decrease in Symptoms With Their Late Sequela the 5. Time of Treatment | pain | 0 participants |