Clinical trial · Interventional
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer
Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
NCT00077090CI-TRIAL-00013017unknownPhase 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)
RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for cancer. PURPOSE: This randomized phase II trial is studying hyperbaric oxygen to see how well it works compared to standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
| Radiation Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperbaric oxygen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Volume of the affected limb, expressed as a percentage of the contralateral limb Volume on the day of measurement, as measured by perometer 12 months after baseline assessment
Secondary outcomes (3)
- measure
- Patient self-assessments, using specific quality of life scale in upper limb lymphoedema and the UK SF-36 Health Survey Questionnaire, at 3, 6, 9 and 12 months after baseline assessment
- measure
- 99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
- measure
- Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * History of early breast cancer (T1-3, N0-1, M0) * Prior breast surgery with or without axillary dissection * Prior breast/chest wall radiotherapy with or without radiotherapy to the supraclavicular fossa and/or axilla, completed at least 2 years ago * Arm lymphedema * At least 15% increase in arm volume * No evidence of cancer recurrence * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Female or male Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Pulmonary * No chronic obstructive airway disease * No bullous lung disease * No acute or chronic pulmonary infection * No uncontrolled asthma * No untreated pneumothorax Other * Physically and psychologically fit for HBO therapy * No claustrophobia * No epilepsy * No eustachian tube dysfunction * No recurrent attacks of vertigo * No contraindication to MRI (e.g., intracranial ferrous material) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics * No prior ear operations Other * No prior hyperbaric oxygen (HBO) therapy, except as treatment for decompression illness
References
Publications (0)
Data not yet available
No reference posted for this study.