Larynx CancerNCT01084733
Nicotine Levels With Response Rates to Radiation Alone or With Chemo In Head & Neck Cancer
An observational study of Larynx Cancer and Lip Cancer, run by Mahesh Kudrimoti at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Larynx Cancer, Lip Cancer, Oral Cavity Cancer
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female aged 18 or older
Who may be able to join
- A: Male or female aged 18 or older
- B: Pathologically confirmed squamous cell carcinoma
- C: Measurable disease using CT, MRI, or panendoscopy
- D: Tumor sites to include:
- Oropharynx Hypopharynx Oral cavity Larynx Measurable disease with no evidence of primary
- E: Patients to be treated with radiotherapy or chemoradiotherapy as a primary treatment modality. Patients to be treated with radiotherapy in combination with platinum based chemotherapy will be considered for enrollment.
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- F: Nutritional status to include patients that do not require placement of a feeding tube as well as patients that are feeding tube dependent. However, patients requiring total parenteral nutrition prior to initiation of treatment will be excluded.
- G: ECOG performance status of 0, 1 or 2.
- H: Standard of care chemotherapy inclusion criteria to include:
- i: No evidence of active angina pectoris or ventricular arrhythmia's; no myocardial infarction within the last six months. (Patients with medically controlled hypertension or congestive heart failure are eligible.) ii: Absolute neutrophil count of > 1000/uL and platelet count > 100,000/uL iii: Serum total bilirubin < 1.5 mg/dL iv: Creatinine Clearance greater than 60 ml/min creatinine clearance to be calculated using the formula: (140 - age) x (wgt in kg) (serum creatinine) x (72)
- multiply by 0.85 for females v: If a pre-existing grade I neuropathy exists, patients must be willing to risk worsening neuropathy secondary to treatment. Patients with grade II or greater neuropathy will be excluded from study.
- I: Standard of care treatment will require counseling against the use of tobacco products and can include nicotine replacement at the request of the patient and discretion of treating physician. Patients who continue to use tobacco products as well as patients using any form of cessation strategy (nicotine replacement, bupropion, or other) will be eligible for enrollment.
- J: Patients enrolled on experimental studies will be considered for enrollment with final selection to be made by Dr. Kudrimoti, Dr. Warren, Dr. Arnold, and Dr. Valentino.
- K: Ability to give informed consent
Who cannot join
- A: Pregnant females. Males and females of childbearing potential must use effective contraception in order to prevent pregnancy during therapy.
- B: Histology other than squamous cell carcinoma
- C: Patients without measurable disease using CT, MRI, or panendoscopy
- D: Patients eligible for surgical resection alone or with significant (> 25%) surgical tumor debulking prior to radiotherapy will not be considered for enrollment. Furthermore, patients who are otherwise not candidates for radiotherapy at the discretion of the treating physician will be excluded from enrollment.
- E: Patients with a history of previous or current malignancy at other sites diagnosed within the last 5 years, with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain free of recurrence or metastases for greater than five years are eligible.
- F: Patients with active infection will not be eligible for this protocol until the infection is treated and the symptoms have clinically resolved.
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- G: Prior chemotherapy, prior irradiation or surgery for SCCHN will not be allowed.
- H: Patients with metastatic disease will not be eligible for this study.
- I: Patients with grade II or greater peripheral neuropathy will be excluded from study.
- J: Patients receiving medication to prevent mucositis (palifermin, amifostine, or other).
- K: Patients requiring total parenteral nutritional support prior to the initiation of treatment will not be eligible for study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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).
- Medical subject headings
- Laryngeal Neoplasms, Lip Neoplasms, Mouth Neoplasms, Pharyngeal Neoplasms, Oropharyngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of serum cotinine with volumetric response
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.
Measured: 2 years from start of treatment
Secondary outcomes (5)
Correlation of serum cotinine with toxicities during 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.
Measured: 90 days from start of treatment
Correlation of serum cotinine with time to progression.
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
Measured: 2 years
Correlation of serum cotinine with survival
Survival will be calculated from the start of radiation to the date of death.
Measured: 5 years from start of treatment
Correlation of serum cotinine with response to treatment
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.
Measured: 5 years
Investigate the hemodynamic responses to different nicotine levels and different therapies (radiation alone, radiation + chemotherapy).
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
Measured: End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startAug 2007
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahesh Kudrimoti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahesh Kudrimoti, University of Kentucky
- Investigators
- Mahesh Kudrimoti, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084733
- Sponsor's protocol ID
- MCC-06-0781-P3K
- Other IDs
- NICOTINE-HN
- Status last verified
- Jul 2021
- First submitted
- 9 Mar 2010
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01084733
- Acronym / sponsor ID
- MCC-06-0781-P3K
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Mahesh KudrimotiUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female aged 18 or older
Key inclusion criteria (14 listed)
- A: Male or female aged 18 or older
- B: Pathologically confirmed squamous cell carcinoma
- C: Measurable disease using CT, MRI, or panendoscopy
- D: Tumor sites to include:
- Oropharynx Hypopharynx Oral cavity Larynx Measurable disease with no evidence of primary
Key exclusion criteria (11 listed)
- A: Pregnant females. Males and females of childbearing potential must use effective contraception in order to prevent pregnancy during therapy.
- B: Histology other than squamous cell carcinoma
- C: Patients without measurable disease using CT, MRI, or panendoscopy
- D: Patients eligible for surgical resection alone or with significant (> 25%) surgical tumor debulking prior to radiotherapy will not be considered for enrollment. Furthermore, patients who are otherwise not candidates for radiotherapy at the discretion of the treating physician will be excluded from enrollment.
- E: Patients with a history of previous or current malignancy at other sites diagnosed within the last 5 years, with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain free of recurrence or metastases for greater than five years are eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Correlation of serum cotinine with toxicities during treatment.
Time frame: 90 days from start of treatment
Correlation of serum cotinine with time to progression.
Time frame: 2 years
Correlation of serum cotinine with survival
Time frame: 5 years from start of treatment
Correlation of serum cotinine with response to treatment
Time frame: 5 years
Investigate the hemodynamic responses to different nicotine levels and different therapies (radiation alone, radiation + chemotherapy).
Time frame: End of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahesh Kudrimoti, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Larynx Cancer and Lip Cancer, run by Mahesh Kudrimoti at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of serum cotinine with volumetric response (time frame: 2 years from start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.