Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck
Condition: Carcinoma, Squamous Cell; Cancer of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This research is being done because we do not know the best treatment for advanced Squamous
      Cell Carcinoma of the Head and Neck. These cancers have been treated with a combination of
      surgery, radiation and chemotherapy in varying combination. When the tumor is inoperable,
      radiation therapy is used with or without chemotherapy in the hope of curing the tumor.

      Recently, it has become recognized as generalized knowledge that cancer cells are hypoxic
      (low oxygen concentration). Because of the low oxygen concentrations, many cancer treatments
      have not been successful. The theory behind this study is to give oxygen to patients prior to
      chemotherapy and radiation in hopes of generating greater results in killing cancer cells.
      The purpose of this study has two main objectives. The primary objective is to determine
      patient tolerance to each arm of the trial.

      The second objective is to determine the feasibility of treatment delivery and acute
      toxicities associated with each regimen.

      It is our intention to undertake a randomized and controlled trial should this Phase I trial
      prove successful in terms of patient tolerance.
    

Detailed 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.
    

Intervention name(s): Hyperbaric Oxygen Therapy; Hyperbaric Oxygen; Hyperbaric oxygen; Hyperbaric oxygen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute; Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute; Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute; Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment