Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Hot Flashes; Amenorrhea
• Interventions: Other: hydrotherapy according to Kneipp rules

• Registration Number: NCT00243607
• Lead Sponsor: Heidelberg University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2005-10-21
• Study First Submitted QC: 2005-10-21
• Study First Posted: 2005-10-24
• Study Start: 2006-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-06
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate treatment group (SBG)	hydrotherapy according to Kneipp rules	immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)

Primary Outcome Measures

Name	Time	Method
Menopausal complaints (MRS II)	12 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Cortisol profile (saliva)	12 and 24 weeks

Trial Locations

Locations (1)

Ambulanz für Naturheilkunde und Integrative Medizin; 🇩🇪 Heidelberg, Baden-Württemberg, Germany