AmenorrheaNCT00243607
Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors
A study testing hydrotherapy according to Kneipp rules in people with Amenorrhea and Hot Flashes, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Amenorrhea, Hot Flashes
- What is being tested?
- hydrotherapy according to Kneipp rules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- May 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ambulanz für Naturheilkunde und Integrative Medizin
Heidelberg, Baden-Wurttemberg, D-69115
About this study
Official title: Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy
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.
- Conditions
- Amenorrhea, Hot Flashes
- Being tested
- hydrotherapy according to Kneipp rules
- Keywords
- climacteric symptoms, breast cancer, hydrotherapy
- Medical subject headings
- Amenorrhea, Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrotherapy according to Kneipp rulesOther
2-5 applications of hydrotherapy according to Kneipp rules (self application) per day
| Study group | Role | What they receive |
|---|---|---|
| immediate treatment group (SBG) | Experimental | immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG) Receives: Other: hydrotherapy according to Kneipp rules |
| waiting group (WG) | No intervention | start of hydrotherapy (self treatment) after waiting period of 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal complaints (MRS II)
Measured: 12 and 24 weeks
Secondary outcomes (1)
Cortisol profile (saliva)
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startMay 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Cornelia von Hagens, Heidelberg University
- Investigators
- Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD), Study chair, Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243607
- Sponsor's protocol ID
- HD175-05
- Status last verified
- Jun 2009
- First submitted
- 21 Oct 2005
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy
- ClinicalTrials.gov ID
- NCT00243607
- Acronym / sponsor ID
- HD175-05
- Conditions
- Amenorrhea, Hot Flashes
- Keywords
- climacteric symptoms, breast cancer, hydrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- May 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate treatment group (SBG) | Experimental | Other: hydrotherapy according to Kneipp rulesimmediate start of hydrotherapy (self treatment) in immediate treatment group (SBG) |
| waiting group (WG) | No intervention | –start of hydrotherapy (self treatment) after waiting period of 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrotherapy according to Kneipp rules2-5 applications of hydrotherapy according to Kneipp rules (self application) per day | Other | immediate treatment group (SBG) |
Primary outcome
Menopausal complaints (MRS II)
Time frame: 12 and 24 weeks
1 secondary outcome
Cortisol profile (saliva)
Time frame: 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD) study chair
Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrotherapy according to Kneipp rules in people with Amenorrhea and Hot Flashes, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopausal complaints (MRS II) (time frame: 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.