Supportive Effects of Craniosacral Therapy for Women With Breast Cancer

NCT ID: NCT04319510

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2025-09-11

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Craniosacral therapy

24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization.

Group Type: EXPERIMENTAL

Craniosacral therapy

Intervention Type: PROCEDURE

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 training

24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization.

Group Type: EXPERIMENTAL

Craniosacral self-help group training

Intervention Type: PROCEDURE

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 usual / wait list control

Waiting period of six months.

Group Type: OTHER

Treatment as usal / wait list

Intervention Type: PROCEDURE

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.

Interventions

Craniosacral therapy

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.

Intervention Type: PROCEDURE

Craniosacral self-help group training

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.

Intervention Type: PROCEDURE

Treatment as usal / wait list

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Planned surgery, adjuvant therapy (chemotherapy and/or radtiation), or rehabilitation during the study period
• Pregnancy
• Simultaneous participation in other clinical trials

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Heidemarie Haller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustav Dobos, Prof. MD

Role: STUDY_DIRECTOR

Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

Locations

Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

Essen, , Germany

Breast Unit, Evang. Kliniken Essen-Mitte

Essen, , Germany

Department of Gynecology and Obstetrics, University Hospital Essen, University of Duisburg-Essen

Essen, , Germany

Countries

Germany

Other Identifiers

2019402

Identifier Type: -

Identifier Source: org_study_id