Clinical trial · Interventional
Hyperbaric Oxygen Therapy to Reduce Lymphedema After Breast Cancer -an Explorative Clinical Trial
NCT02895724CI-TRIAL-00031593HBOT-LYCAunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Secondary Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical Oxygen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HBOT receivers
- description
- Participants in a post breast cancer surgery randomized controlled trial detected with lymphedema 1 year postoperatively are invited to 40 consequtive treatments of hyperbaric oxygen therapy to reduce lymphedema. The experimental drug is 100% medical oxygen given in a pressure chamber of 2,4 bar,every treatment lasting approximately 100 minutes.
- interventionNames
- Drug: Medical Oxygen
- type
- NO_INTERVENTION
- label
- blodsample comparison
- description
- Matched Lymphedema free participants from LYCA Exercise recruited to donate blood samples for comparison on important blod biomarkers and collagen levels.
Primary outcomes (1)
- measure
- Arm volume
- timeFrame
- 8 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.