Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

NCT00243607 | Completed

• 1 other identifier: HD175-05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Amenorrhea; Hot Flashes

Keywords

climacteric symptoms; breast cancer; hydrotherapy

Outcome Measures

Primary Outcomes (1)

• Menopausal complaints (MRS II)

  12 and 24 weeks

Secondary Outcomes (1)

• Cortisol profile (saliva)

  12 and 24 weeks

Study Arms (2)

immediate treatment group (SBG)

EXPERIMENTAL

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

Other: hydrotherapy according to Kneipp rules

waiting group (WG)

NO INTERVENTION

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

Interventions

hydrotherapy according to Kneipp rules OTHER

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

immediate treatment group (SBG)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Regular intake of glucocorticoids
• 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)

Sponsors & Collaborators

• Heidelberg University: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Ambulanz für Naturheilkunde und Integrative Medizin

Heidelberg, Baden-Wurttemberg, D-69115, Germany

Location

MeSH Terms

Conditions

Amenorrhea; Hot Flashes; Breast Neoplasms

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD)

  Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Complementary & Integrative Medicine, Dep. 4.2

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 24, 2005
• Study Start: May 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 8, 2017

Record last verified: 2009-06

Locations

DE (1)