Phase I Clinical Trial of Hyperbaric Oxygen Combined With Radiation and Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient tolerance to each arm of the study
During intervention phase
No
Dick Clarke, CHT
Study Director
The Baromedical Research Foundation
United States: Institutional Review Board
BRF 06-01
NCT00474825
July 2007
February 2011
Name | Location |
---|---|
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
The Mayo Clinic | Rochester, Minnesota 55905 |
Norfolk General Hospital / Eastern Virginia Medical School | Norfolk, Virginia 23507 |