Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

Hot Flashes Clinical Trial

Official title:

Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243607
• Other study ID #: HD175-05
• Status: Completed
• Phase: N/A
• First received: October 21, 2005
• Last updated: May 3, 2017
• Start date: May 2006
• Est. completion date: October 2008

Study information

• Verified date: June 2009
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breast cancer survivors often suffer from climacteric symptoms caused by treatment or diagnosis of their disease.

Hormone replacement therapy is contraindicated and other pharmacological options may also include the risk of stimulating hormone receptors. Hydrotherapy following the guidelines of naturopathy by S. Kneipp is a non-pharmacological treatment option which may influence climacteric symptoms by affecting the regulation of body temperature. In this study, the regular self application of hydrotherapy after initial training by a professional will be evaluated for its efficacy, practicability, and compatibility.

Description:

Patients should use 2-5 different treatment options per day and fulfill a diary for symptoms and adherence to self-treatment for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer diagnosis

• Menopausal complaints score > 14 (MRS II)

• End of last chemotherapy or radiotherapy > 2 months

• Expected stable disease for the next 6 months

Exclusion Criteria:

• Regular intake of glucocorticoids

• Regular practice of hydrotherapy before inclusion

• Start or change of other treatments/changes of lifestyle in order to influence menopausal symptoms

• Psychiatric disorders with possible influence on compliance and adherence to the protocol

• Other severe or progressive diseases with influence on compliance and adherence to the protocol

• Contraindications to hydrotherapy (severe heart failure, relevant dermatological diseases, Raynaud's Phenomenon [M. Raynaud], peripheral arterial occlusive disease Fontaine stage IIb [VK IIb] or more, acute thrombosis, or thrombophlebitis)

Related Conditions & MeSH terms

• Amenorrhea
• Breast Neoplasms
• Hot Flashes

Intervention

Other:
• hydrotherapy according to Kneipp rules
2-5 applications of hydrotherapy according to Kneipp rules (self application) per day

Locations

Country	Name	City	State
Germany	Ambulanz für Naturheilkunde und Integrative Medizin	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopausal complaints (MRS II)		12 and 24 weeks
Secondary	Cortisol profile (saliva)		12 and 24 weeks