Prevention of wound complications with hyperbaric oxygen therapy for soft tissue sarcoma patients

PREVENTION OF WOUND COMPLICATIONS WITH HYPERBARIC OXYGEN THERAPY DURING PREOPERATIVE RADIOTHERAPY FOR PATIENTS WITH SOFT TISSUE SARCOMA: A PHASE II STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22338

Enrollment

Registered

2016-02-13

Start date

2016-04-02

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sarcoma, hyperbaric oxygen, preoperative radiotherapy

Interventions

Hyperbaric Oxygen, 90 minutes per , 5 days per week, during the radiotherapy course (25 fractions)

Eligibility

Inclusion criteria

Inclusion criteria: - Patients ¡Ý 18 years old - Tumor size of > 5 cm. - Primary tumour site: extremity, trunk, groin, (excluding intra-abdominal and retroperitoneal sarcomas) - WHO performance status ¡Ü 2 - Written informed consent - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. - Every patient has been discussed in the local tumor board. - A MRI scan of the tumor not older than 6 weeks. -CT thorax not older than 6 weeks. - a resectable tumor according to the surgeon

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Other malignancy with a life expectancy of less than 2 years. - Prior radiotherapy to the local site - Presence of metastases - Chemotherapy needed for this sarcoma - Patients with contraindications for hyperbaric oxygen therapy: Pneumothorax, TBC, COPD Gold IV, bullae, myocardial infarction, EF 30%, serious cardiac valve problems, acute ischaemic CVA, unstable epilepsy.

Design outcomes

Primary

Measure	Time frame
The primary objective will be the number, size and features of postoperative wound complications during the first 4 months after surgery	—

Secondary

Measure	Time frame
- the acute toxicity during radiotherapy with HBOT according to the to the Common Terminology Crtiteria for Adverse Events 4 (CTC-AE4). - the tumor response will also be evaluated with a MRI 2 weeks before the surgery according to the RECIST criteria. - the percentage of necrosis in the pathology specimen.	—

Contacts

Public ContactJ.J. Nuyttens

j.nuyttens@erasmusmc.nl+31 (0)10 7041766

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)