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CompletedNCT00243607Updated May 8, 2017

Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

An interventional study of hydrotherapy according to Kneipp rules in Amenorrhea and Hot Flashes, sponsored by Heidelberg University. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-08.

Sponsored by Heidelberg University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Amenorrhea
  • Hot Flashes

Keywords

  • climacteric symptoms
  • breast cancer
  • hydrotherapy
03

In context

Hot Flashes

285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.

This study's enrollment of 45 is below the median of 90 across 255 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    immediate treatment group (SBG)

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

    Other: hydrotherapy according to Kneipp rules

  • No intervention
    waiting group (WG)

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

Interventions

  • Otherhydrotherapy according to Kneipp rules

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

06

What researchers measure

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

07

Study locations

1 site
  • Ambulanz für Naturheilkunde und Integrative Medizin
    Heidelberg, Baden-Württemberg D-69115, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00243607
Lead sponsor
Heidelberg University
Collaborators
Charite University, Berlin, Germany
Responsible party
Cornelia von Hagens (Head Complementary & Integrative Medicine, Dep. 4.2, Heidelberg University) — Principal investigator
First posted
Oct 24, 2005
Start date
May 2006
Primary completion
Oct 2008
Completion
Oct 2008
Last update
May 8, 2017

Study contacts

Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD)
study chair · Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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