Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00243607

Collaborator

Charite University, Berlin, Germany (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amenorrhea Hot Flashes	Other: hydrotherapy according to Kneipp rules	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: immediate treatment group (SBG) immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)	Other: hydrotherapy according to Kneipp rules 2-5 applications of hydrotherapy according to Kneipp rules (self application) per day
No Intervention: waiting group (WG) start of hydrotherapy (self treatment) after waiting period of 12 weeks

Arm

Intervention/Treatment

Experimental: immediate treatment group (SBG)

immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)

Other: hydrotherapy according to Kneipp rules

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

No Intervention: waiting group (WG)

start of hydrotherapy (self treatment) after waiting period of 12 weeks

Outcome Measures

Primary Outcome Measures

Menopausal complaints (MRS II) [12 and 24 weeks]

Secondary Outcome Measures

Cortisol profile (saliva) [12 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ambulanz für Naturheilkunde und Integrative Medizin	Heidelberg	Baden-Württemberg	Germany	D-69115

Sponsors and Collaborators

Heidelberg University
Charite University, Berlin, Germany

Investigators

Study Chair: Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD), Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus