Phase I Clinical Trial of Hyperbaric Oxygen Combined With Radiation and Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Description:
The goal of this study is to see if patients can tolerate HBO therapy up to five days a week.
Three patients in Arm 1 (HBO on Monday and Friday) will be observed throughout their course
of concomitant radiation, chemo and hyperbaric therapy. If these patients appear to tolerate
this protocol well, and no adverse effects that can be directly attributed to HBO are
observed, then three more patients will be recruited for Arm 2 (HBO on Monday, Wednesday, and
Friday). If again these patients appear to tolerate this protocol well, and no adverse
effects that can be directly attributed to HBO are observed, then a third group of three
patients will be recruited for Arm 3 (HBO Monday through Friday).
If Grade IV acute toxicity is reported for a single patient in any of the arms, 3 more
patients will be recruited in the same arm. If no further adverse events occur, the protocol
progresses to the next arm. If Grade IV acute toxicity is observed even a single patient, the
study will be stopped.
Tumor and/or lymphatic tissue specimens will be obtained prior to starting treatment. Tumor
tissue specimens will be analyzed to determine whether there is a predictive susceptibility
of tumors to HBO sensitization using currently defined biomarkers known to correlate with
survival.
Condition:
Carcinoma, Squamous Cell
Treatment:
Hyperbaric Oxygen Therapy
Start Date:
July 2007
Sponsor:
National Baromedical Services
For More Information:
https://clinicaltrials.gov/show/NCT00474825