Breast CancerCRANIO4USNCT04319510
Supportive Effects of Craniosacral Therapy for Women With Breast Cancer
A study testing Craniosacral therapy, Craniosacral self-help group training and Treatment as usal / wait list in people with Breast Cancer and Complementary Therapies, run by Universität Duisburg-Essen at 3 sites in Germany.
Trial summary
Craniosacral Therapy (CST) is a non-manipulative, very gentle, manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system, which is often increased in chronically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Complementary Therapies
- What is being tested?
- Craniosacral therapy, Craniosacral self-help group training and Treatment as usal / wait list
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesGermany
- Study dates
- 18 Sep 2023to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer (stage I-III) survivors after finishing curative chemotherapy and/or radiation
- Impaired breast caner-related quality of life (< 112,8 points on the FACT-B)
Who cannot join
- Planned surgery, adjuvant therapy (chemotherapy and/or radtiation), or rehabilitation during the study period
- Pregnancy
- Simultaneous participation in other clinical trials
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
Essen, 45130
Breast Unit, Evang. Kliniken Essen-Mitte
Essen, 45276
Department of Gynecology and Obstetrics, University Hospital Essen, University of Duisburg-Essen
Essen
About this study
Official title: Supportive Effects of Craniosacral Therapy for Women With Breast Cancer: a Randomized Controlled Trial
Craniosacral Therapy (CST) is a non-manipulative, very gentle, manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system, which is often increased in chronically ill patients. Initial randomized trials support CST's efficacy and effectiveness in reducing symptoms of patients with psychosomatic and chronic pain disorders. To date, there is no trial investigating the effectiveness of CST as a supportive strategy for enhancing cancer-related quality of life in women with breast cancer. In clinical practice, therapists also report alleviating as well as regulating effects of simple CST self-help techniques, offered to patients within a group concept.
Within the recent study, a CST treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group. The first group will receive 24 units of CST treatment in a 1:1 setting with a certified craniosacral therapist over 12 weeks. The second group will receive 24 units of group training in CST self-help techniques offered by a certified craniosacral therapist over 12 weeks. They will be reassessed after 12 and 26 weeks (6 months) after randomization. The third group will wait for 26 weeks and will receive no specific study intervention. After 26 weeks patients of the third group were offered self-selection to either individual CST or CST self-help group training. For all groups, treatment as usual is allowed.
- Conditions
- Breast Cancer, Complementary Therapies
- Being tested
- Craniosacral therapy, Craniosacral self-help group training, Treatment as usal / wait list
- Keywords
- Craniosacral Therapy, Breast cancer, Randomized Controlled Trial, Self-help strategies, Self-efficacy, Coping
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniosacral therapyProcedure or surgery
The first experimental group of patients will receive 24 units à 45 minutes over 12 weeks (2 consecutive units per week) offered by a trained craniosacral therapist within a 1:1 setting. Treatment as usual is allowed.
Craniosacral self-help group trainingProcedure or surgery
The second experimental group of patients will receive 24 teaching units (TUs) à 45 minutes over 12 weeks offered by a trained craniosacral therapist within a group setting. The group training will start with an introductory day (8 TUs), followed by 6 practice evenings every two weeks (2 TUs each) and a final afternoon (4 TUs). The patients have to agree to participate in the introductory day and 90% of the following TUs. All patients will receive a script with theoretical CST information and descriptions of the learned techniques, which should facilitate the correct practice at home. Treatment as usual is allowed.
Treatment as usal / wait listProcedure or surgery
The control group will receive no specific study treatment for a waiting period of six months. Treatment as usual is allowed. Afterwards they were offered self-selection to 1:1 CST or participation in the CST self-help group training.
| Study group | Role | What they receive |
|---|---|---|
| Craniosacral therapy | Experimental | 24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization. Receives: Procedure: Craniosacral therapy |
| Craniosacral self-help group training | Experimental | 24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization. Receives: Procedure: Craniosacral self-help group training |
| Treatment as usual / wait list control | Other | Waiting period of six months. Receives: Procedure: Treatment as usal / wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer-related quality of life - total score
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 37 self-report items and assesses the specific breast cancer-related quality of life as a total score of 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
Measured: week 12
Secondary outcomes (21)
Breast cancer-related quality of life - sub scores
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 37 self-report items and assesses the specific breast cancer-related quality of life on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
Measured: week 12
Breast cancer-related quality of life - total score
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 37 self-report items (4 general subscales and one breast-cancer specific subscale, which will be summarized to a total score) and assesses the specific breast cancer-related quality of life. A higher score indicates a higher cancer-related quality of life.
Measured: week 26
Breast cancer-related quality of life - sub scores
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 37 self-report items and assesses the specific breast cancer-related quality of life on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
Measured: week 26
Fatigue
Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Questionnaire: The addoitional F-scale of the FACT consists of 13 self-report items and assesses fatigue related to cancer on 1 scale. A higher score indicates a higher cancer-related fatigue.
Measured: week 12
Fatigue
Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Questionnaire: The addoitional F-scale of the FACT consists of 13 self-report items and assesses fatigue related to cancer on 1 scale. A higher score indicates a higher cancer-related fatigue.
Measured: week 26
Endocrine symptoms
Funcitonal Assessment of Cancer - Endocrine Symptom (FACT-ES) Questionnaire: The additonal ES-scale of the FACT consists of 19 self-report items and assesses symptoms related to the endocrine system / antihormonal therapy on 1 scale. A higher score indicates a higher endocrine symptoms.
Measured: week 12
Endocrine symptoms
Funcitonal Assessment of Cancer - Endocrine Symptom (FACT-ES) Questionnaire: The additonal ES-scale of the FACT consists of 19 self-report items and assesses symptoms related to the endocrine system / antihormonal therapy on 1 scale. A higher score indicates a higher endocrine symptoms.
Measured: week 26
Sleep disturbance
Patient related outcomes measurement information system - sleep disturbance (PROMIS-SD) Short form: The SD-short form of the PROMIS consists of 8 self-report items and assesses the disturbance of sleep on 1 scale. A higher score indicates higher disturbances of the sleep.
Measured: week 12
Sleep disturbance
Patient related outcomes measurement information system - sleep disturbance (PROMIS-SD) Short form: The SD-short form of the PROMIS consists of 8 self-report items and assesses the disturbance of sleep on 1 scale. A higher score indicates higher disturbances of the sleep.
Measured: week 26
Severity of insomnia
Insomnia Severity Index (ISI): The ISI consists of 7 self-report items and assesses the severity of insomnia on 1 scale. A higher score indicates higher severity of insomnia.
Measured: week 12
Severity of insomnia
Insomnia Severity Index (ISI): The ISI consists of 7 self-report items and assesses the severity of insomnia on 1 scale. A higher score indicates higher severity of insomnia.
Measured: week 26
State anxiety
Patient related outcomes measurement information system - anxiety/emotional distress (PROMIS-A/ED) Short form: The A/ED-short form of the PROMIS consists of 7 self-report items and assesses state anxiety on one scale. A higher score indicates higher anxiety.
Measured: week 12
State anxiety
Patient related outcomes measurement information system - anxiety/emotional distress (PROMIS-A/ED) Short form: The A/ED-short form of the PROMIS consists of 7 self-report items and assesses state anxiety on one scale. A higher score indicates higher anxiety.
Measured: week 26
Fear of recurrence
The Fear of Relapse/Recurrence Scale (FRRS): The FRRS consists of 5 self-report items and assesses the fear of cancer recurrence on one scale. A higher score indicates higher fear of recurrence.
Measured: week 12
Fear of recurrence
The Fear of Relapse/Recurrence Scale (FRRS): The FRRS consists of 5 self-report items and assesses the fear of cancer recurrence on one scale. A higher score indicates higher fear of recurrence.
Measured: week 26
Severity of depressive symptoms
Center for epdiemiologic studies depression scale (CES-D): The CES-D consists of 10 self-report items and assesses the severity of depressive symptoms on one scale. A higher score indicates higher severity of depressive symptoms.
Measured: week 12
Severity of depressive symptoms
Center for epdiemiologic studies depression scale (CES-D): The CES-D consists of 10 self-report items and assesses the severity of depressive symptoms on one scale. A higher score indicates higher severity of depressive symptoms.
Measured: week 26
Number of patients with adverse events
The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: week 12
Number of patients with adverse events
The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: week 26
Total number, type, and grade of adverse events
The total number, type and grade of adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: week 12
Total number, type, and grade of adverse events
The total number, type and grade of adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start18 Sep 2023
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319510
- Sponsor's protocol ID
- 2019402
- Acronym
- CRANIO4US
- Status last verified
- Jan 2026
- First submitted
- 20 Mar 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Effects of Craniosacral Therapy for Women With Breast Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04319510
- Acronym / sponsor ID
- CRANIO4US / 2019402
- Conditions
- Breast Cancer, Complementary Therapies
- Keywords
- Craniosacral Therapy, Breast cancer, Randomized Controlled Trial, Self-help strategies, Self-efficacy, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Craniosacral Therapy (CST) is a non-manipulative, very gentle, manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system, which is often increased in chronically ill patients. Initial randomized trials support CST's efficacy and effectiveness in reducing symptoms of patients with psychosomatic and chronic pain disorders. To date, there is no trial investigating the effectiveness of CST as a supportive strategy for enhancing cancer-related quality of life in women with breast cancer. In clinical practice, therapists also report alleviating as well as regulating effects of simple CST self-help techniques, offered to patients within a group concept.
Within the recent study, a CST treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group. The first group will receive 24 units of CST treatment in a 1:1 setting with a certified craniosacral therapist over 12 weeks. The second group will receive 24 units of group training in CST self-help techniques offered by a certified craniosacral therapist over 12 weeks. They will be reassessed after 12 and 26 weeks (6 months) after randomization. The third group will wait for 26 weeks and will receive no specific study intervention. After 26 weeks patients of the third group were offered self-selection to either individual CST or CST self-help group training. For all groups, treatment as usual is allowed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Craniosacral therapy | Experimental | Procedure: Craniosacral therapy24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization. |
| Craniosacral self-help group training | Experimental | Procedure: Craniosacral self-help group training24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization. |
| Treatment as usual / wait list control | Other | Procedure: Treatment as usal / wait listWaiting period of six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast cancer (stage I-III) survivors after finishing curative chemotherapy and/or radiation
- Impaired breast caner-related quality of life (< 112,8 points on the FACT-B)
Key exclusion criteria (3 listed)
- Planned surgery, adjuvant therapy (chemotherapy and/or radtiation), or rehabilitation during the study period
- Pregnancy
- Simultaneous participation in other clinical trials
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 therapyThe first experimental group of patients will receive 24 units à 45 minutes over 12 weeks (2 consecutive units per week) offered by a trained craniosacral therapist within a 1:1 setting. Treatment as usual is allowed. | Procedure or surgery | Craniosacral therapy |
| Craniosacral self-help group trainingThe second experimental group of patients will receive 24 teaching units (TUs) à 45 minutes over 12 weeks offered by a trained craniosacral therapist within a group setting. The group training will start with an introductory day (8 TUs), followed by 6 practice evenings every two weeks (2 TUs each) and a final afternoon (4 TUs). The patients have to agree to participate in the introductory day and 90% of the following TUs. All patients will receive a script with theoretical CST information and descriptions of the learned techniques, which should facilitate the correct practice at home. Treatment as usual is allowed. | Procedure or surgery | Craniosacral self-help group training |
| Treatment as usal / wait listThe control group will receive no specific study treatment for a waiting period of six months. Treatment as usual is allowed. Afterwards they were offered self-selection to 1:1 CST or participation in the CST self-help group training. | Procedure or surgery | Treatment as usual / wait list control |
Primary outcome
Breast cancer-related quality of life - total score
Time frame: week 12
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 37 self-report items and assesses the specific breast cancer-related quality of life as a total score of 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
21 secondary outcomes
Breast cancer-related quality of life - sub scores
Time frame: week 12
Breast cancer-related quality of life - total score
Time frame: week 26
Breast cancer-related quality of life - sub scores
Time frame: week 26
Fatigue
Time frame: week 12
Fatigue
Time frame: week 26
Endocrine symptoms
Time frame: week 12
Endocrine symptoms
Time frame: week 26
Sleep disturbance
Time frame: week 12
Sleep disturbance
Time frame: week 26
Severity of insomnia
Time frame: week 12
Severity of insomnia
Time frame: week 26
State anxiety
Time frame: week 12
State anxiety
Time frame: week 26
Fear of recurrence
Time frame: week 12
Fear of recurrence
Time frame: week 26
Severity of depressive symptoms
Time frame: week 12
Severity of depressive symptoms
Time frame: week 26
Number of patients with adverse events
Time frame: week 12
Number of patients with adverse events
Time frame: week 26
Total number, type, and grade of adverse events
Time frame: week 12
Total number, type, and grade of adverse events
Time frame: week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Gustav Dobos, Prof. MD study director
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
3 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, Craniosacral self-help group training and Treatment as usal / wait list in people with Breast Cancer and Complementary Therapies, run by Universität Duisburg-Essen at 3 sites in Germany.
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 3 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Breast cancer-related quality of life - total score (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.