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OpenTrials
Completed

NCT Number: NCT00243607

Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ambulanz für Naturheilkunde und Integrative Medizin

Heidelberg, Baden-Wurttemberg, D-69115, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

hydrotherapy according to Kneipp rules

Other

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

Primary outcomes

  1. Menopausal complaints (MRS II)

    Time frame: 12 and 24 weeks

Secondary outcomes

  1. Cortisol profile (saliva)

    Time frame: 12 and 24 weeks

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 24, 2005
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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