Nicotine Levels With Response Rates to Radiation Alone or With Chemo In Head & Neck Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01084733|
Recruitment Status : Recruiting
First Posted : March 10, 2010
Last Update Posted : August 15, 2018
The objective of this study is to evaluate the relationship between serum nicotine levels and tumor response of squamous cell cancers of the head and neck (SCCHN) to radiotherapy alone or in combination with chemotherapy.
Correlation of RECIST response, volumatic response, pathologic response (in patients receiving post-treatment neck dissection), and hemodynamic response (tumor oxygenation and blood flow) will be performed.
|Condition or disease|
|Larynx Cancer Lip Cancer Oral Cavity Cancer Pharyngeal Cancer Oropharyngeal Cancer|
The exposure to tobacco related carcinogens is highly dependent upon dose as well as interindividual characteristics of metabolism. Risk assessment of carcinogenic profiles for nicotine and its individual metabolites is complicated by interindividual variations in nicotine metabolism associated with quantitative nicotine exposure, gender, genetic polymorphisms, and behavioral and environmentally induced differences in nicotine metabolizing enzyme activities. Consequently, differences in smoking behavior or tobacco use have been correlated to differences in nicotine metabolism resulting in cessation strategies based upon tobacco use, nicotine dependence, and behavioral modification. Cotinine has been shown to be a reliable marker of nicotine exposure and more reflective of recent rather than acute nicotine use with better assessment of baseline nicotine levels. Therefore, subjects will have blood samples drawn weekly during radiation for cotinine analysis.
Radiation therapy efficacy is known to be dependent on tissue oxygen status. Since therapeutic treatment is less efficacious in patients with poorly vascularized/ hypoxic tumors, it is desirable to identify and target such patients for special treatment. Recent magnetic resonance imaging and computed tomography investigations have shown that there are significant blood flow changes during radiation or chemo-radiation therapy, suggesting that early blood flow may have prognostic value. Among those methods for oxygen and blood flow measurements, the near-infrared spectroscopy (NIRS) is more benefit with merit of non-invasive, portable, fast test, and inexpensive. Our instrument system combined near-infrared diffuse reflectance spectroscopy (DRS) and diffuse correlation spectroscopy (DCS) is capable of monitoring tissue oxygen and blood flow simultaneously. This hybrid diffuse optical instrument has already been used for monitoring of therapeutic effects (e.g., radiation therapy, chemotherapy) in tumors in human head & neck and breast. In this study, we will use this hybrid instrument to investigate the hemodynamic responses to different therapies (radiation alone, radiation + chemotherapy) in patients with different nicotine levels. Baseline measurement of tissue oxygen saturation, total hemoglobin concentration and blood flow using a hybrid optical instrument (DRS for oxygen measurement and DCS for blood flow measurement). A hand-hold optical probe connected to the hybrid instrument will be placed on the head/neck tumor for about 3-5 minutes, then move it on the normal arm muscle for control purposeTumor oxygenation and flow measurements will be performed at the beginning of every week during the treatment period. During this monitoring process non-invasive blood pressure monitoring will also occur. Weekly optical measurements will be obtained during treatment.In this study we will investigate the hemodynamic responses to different nicotine levels and different therapies (radiation alone, radiation + chemotherapy).
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Correlative Study of Nicotine Levels With Response Rates to Therapy Using Radiation Alone or in Combination With Chemotherapy in Head and Neck Cancer|
|Study Start Date :||August 2007|
|Estimated Primary Completion Date :||November 15, 2019|
|Estimated Study Completion Date :||November 2020|
- Correlation of serum cotinine with volumetric response [ Time Frame: 2 years from start of treatment ]RECIST criteria will be used as a correlate for standardization of tumor response. Volumetric analysis may provide better assessment of bulky tumor size that may have a large necrotic or hypoxic component that may be resistant to treatment. Furthermore, volumetric analysis has been associated with a higher rate of concordance to response based upon RECIST criteria.
- Correlation of serum cotinine with toxicities during treatment. [ Time Frame: 90 days from start of treatment ]Toxicities will be graded using the National Cancer Institute (NCI) scale for acute and subacute toxicity and the Radiation Therapy Oncology Group's late toxicity scale.
- Correlation of serum cotinine with time to progression. [ Time Frame: 2 years ]Time to progression will be calculated as the time interval between the start of radiation treatment and the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
- Correlation of serum cotinine with survival [ Time Frame: 5 years from start of treatment ]Survival will be calculated from the start of radiation to the date of death.
- Correlation of serum cotinine with response to treatment [ Time Frame: 5 years ]Both pathologic and radiographic response to therapy will be assessed where possible. Primary tumors will be assessed by the attending otolaryngologist by panendoscopy, with biopsies taken in the case of a question of response. Nodal disease response will be assessed by radiographic means. All patients will be assessed for response at the end of primary treatment.
- Investigate the hemodynamic responses to different nicotine levels and different therapies (radiation alone, radiation + chemotherapy). [ Time Frame: End of Treatment ]Previous studies indicated that there is a significant increase in blood flow in the early two weeks of radiation therapy and decreases in the following weeks, while the tissue oxygen saturation tends to decline continually
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084733
|Contact: Dorothy Rossfirstname.lastname@example.org|
|United States, Kentucky|
|Markey Cancer Center||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator: Mahesh R Kudrimoti, MD|
|Principal Investigator:||Mahesh Kudrimoti, MD||University of Kentucky|