Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Mitogens

Treatment Monday through Friday in a monoplace hyoerbaric chamber 100% oxygen at 2.0 atmospheres (14.7 PSI or the equivalent of being under 33 feet of sea water) for 90 minutes at pressure. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each subject will be treated for two weeks for a total of 10 HBOT treatments

Hyperbaric Oxygen Therapy

Sarah Waheed, MD

The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as a therapeutic option in mobilizing stem cells for autologous stem cell transplant.

Subjects will receive HBOT daily for 10 days in conjunction with standard growth factor treatment regimens for stem cell mobilization. The role of HBOT in stem cell mobilization as well as its role on oxidative stress will be evaluated.

Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization

Pilot Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization

Total stem cells collected from all participants at one week post-study treatment

University of Arkansas

Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens

Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres for 90 minutes at pressure. Treatment lasts about 2 hours as time is allowed for gradual pressurization and depressurization. Treated for two weeks a total of 10 HBOT treatments.

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Study was terminated early because the site that administered the hyperbaric oxygen treatment closed and an alternative site could not be identified. Only four subjects completed the trial.

Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres (the equivalent of being under 33 feet of sea water) for 90 minutes. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each participant will be treated for two weeks for a total of 10 HBOT treatments.

Four of eight enrolled subjects completed the study.

Number of Stem Cells Collected

Overall Study

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Head and Neck Neoplasms

Antineoplastic Agents

Cetuximab

patients with operable head and neck squamous cell carcinoma

patients treated by neck ansd head surgery for a non-oncological disease

patients treated before surgery with 3 doses of neoadjuvant cetuximab

Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.

head and neck surgery

Jean-Pascal Machiels, PhD

The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome

Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Neoplastic Cells, Circulating

Breast Diseases

Skin Diseases

Neoplastic Processes

Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).

In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.

lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)

Surgery

Surgery on Demand

Florian Fitzal, MD

Michael Gnant, MD

Guenther Steger, MD

Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy

This study is a prospective, randomized, multicentre, study concerning the influence of local treatment on the patients with synchronous metastasized breast cancer. Patients will be stratified at inclusion according to the centre, the menopausal status (pre-menopausal, post-menopausal), the hormone-receptor status (ER-/PR-/not determinable; any PR and/or Er+), the HER-2 status (positive vs. negative/not determinable), the grading (G1/G2/not determinable vs. G3), location of metastases (visceral ± vs bone only), organs with metastases (single organ vs multiple organs) and use of first line chemotherapy (anthracycline ± vs. taxane vs others). Thereafter patients will be randomly assigned to receive either local therapy of the breast (lumpectomy or mastectomy + axillary surgery /± radiotherapy) versus no local therapy. Systemic therapy will be administered at the centers policy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization	NCT01449539	Multiple Myelom...	Hyperbaric Oxyg...	18 Years -	University of Arkansas
Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization	NCT01449539	Multiple Myelom...	Hyperbaric Oxyg...	18 Years -	University of Arkansas
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery	NCT01280318	Head and Neck S... Growth Factor Surgery	head and neck s...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer	NCT01015625	Synchronous Met... Circulating Tum...	Surgery Surgery on Dema...	18 Years -	Austrian Breast & Colorectal Cancer Study Group
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery	NCT01280318	Head and Neck S... Growth Factor Surgery	head and neck s...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer	NCT01015625	Synchronous Met... Circulating Tum...	Surgery Surgery on Dema...	18 Years -	Austrian Breast & Colorectal Cancer Study Group

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