Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners

Last updated: October 31, 2024
Sponsor: Universität Duisburg-Essen
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Craniosacral therapy

Treatment as usal / wait list

Craniosacral self-help group training

Clinical Study ID

NCT04319510
2019402
  • Ages > 18
  • Female

Study 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 to take part in two individual CST interventions and the CST self-help training. For all groups, treatment as usual is allowed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Breast cancer (stage I-III) survivors after finishing curative chemotherapy and/orradiation

  • Impaired breast caner-related quality of life (< 112,8 points on the FACT-B)

Exclusion

Exclusion Criteria:

  • Planned surgery, adjuvant therapy (chemotherapy and/or radtiation), orrehabilitation during the study period

  • Pregnancy

  • Simultaneous participation in other clinical trials

Study Design

Total Participants: 102
Treatment Group(s): 3
Primary Treatment: Craniosacral therapy
Phase:
Study Start date:
September 18, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Breast Unit, Evang. Kliniken Essen-Mitte

    Essen, 45276
    Germany

    Site Not Available

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

    Essen, 45130
    Germany

    Site Not Available

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

    Essen,
    Germany

    Site Not Available

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