Secondary Lymphedema Clinical Trial
— HBOT-LYCAOfficial title:
Hyperbaric Oxygen Therapy to Reduce Lymphedema After Breast Cancer -an Explorative Clinical Trial
Verified date | February 2018 |
Source | Danish Cancer Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine if pressurechamber treatment (HBOT) can reduce early stages of breast cancer related lymphedema, and to explore the mechanisms involved in the disease progress.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Participant in "LYCA - exercise" - Declared cancer free - Completed chemotherapy and radiotherapy (maximum 1 year after completed treatment) - Lymphedema present when measured at "Lyca-exercise" 1 year follow-up: >3% increase in inter limb volume change from the baseline measurement, AND a score of 2 points or more on NRS for symptoms (heaviness, tightness, swelling), persisting more than 4 weeks - Two or more of the following clinical criteria must be present (i-iii are compared with the unaffected side): i) decreased visibility of subcutaneous veins on the ventral lower arm or dorsal hand, ii) loss of normal contours in the region of the medial side of the elbow/distal end of the upper arm, iii) thicker skin and subcutis on palpation, iv) pitting edema. Exclusion Criteria - Pregnancy - Undrained pneumothorax - Unability to equalize pressure in the ears in spite of drain treatment by Ear- Nose- and Throat specialist. - Severe heart failure detected during pre-examination for HBOT - Intractable Claustrophobia non-responsive of standard pre-medication |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Danish Cancer Society | Herlev Hospital, Rigshospitalet, Denmark |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arm volume | measured by perometry and DXA scans | 8 months | |
Secondary | lymph clearance | upper limb lymph clearance rate measured by quantitative lymphoscintigraphy | 8 months | |
Secondary | Functional impairment | upper limb functional impairment measured by queationnaire: "Lymph ICF" | 8 months | |
Secondary | psychological well-being | anxiety, depression and health realted quality of life measured by questionnaire | 8 months | |
Secondary | blood biomarkers | biomarkers of inflammation and levels of collagen measured by blood samples | 8 months |
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