Tongue CancerNCT01854021
Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
A study testing intravenous anesthesia, combined intravenous-inhalational anesthesia and inhalational anesthesia in people with Tongue Cancer, run by tiejun Zhang at 1 site in China.
Trial summary
Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced immunosuppression has been implicated in the development of post-operative septic complications and neoplasm metastasis. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Tongue Cancer
- What is being tested?
- intravenous anesthesia, combined intravenous-inhalational anesthesia and inhalational anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Aug 2013
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patients were scheduled for elective surgery for tongue cancer under general anesthesia. None of the patients had a history of endocrine, immune and circulatory system diseases;
- Exclusion criteria were also contraindications for receiving chemotherapy
Who cannot join
- contraindications for receiving chemotherapy,
- receiving perioperative blood transfusion, or
- preoperative and perioperative treatment with hormones and immunomodulatory agent.
- Patients who suffered from any surgical complications such as infection were also excluded from our study.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital of stomatology of wuhan university
Wuhan, Hubei, 430079
tiejun zhang, M.D., 8602787686219, ztj@whu.edu.cn
tiejun zhang, M.D.
About this study
Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced immunosuppression has been implicated in the development of post-operative septic complications and neoplasm metastasis. General anesthesia is considered to not only suppress surgical stress, but also affect the immune function directly，such as altering the number and activity of immune cells. It is reported that some anesthetics increase susceptibility to tumor metastasis, apparently by suppressing natural killer cell activity. Different anesthetic techniques and anesthetics used in anesthesia have shown different effects on immunity. Many of the studies were animal trials or performed in vitro; in addition, most are focused on a single drug. To date, there is little published prospective clinical research designed specifically to investigate the effects of different general anesthetic technique on immune function in patients with oral malignant tumors. The aim of this study is going to characterize the immune response of patients undergoing surgery for tongue cancer under 3 types of general anesthesia.
- Conditions
- Tongue Cancer
- Being tested
- intravenous anesthesia, combined intravenous-inhalational anesthesia, inhalational anesthesia
- Keywords
- Anesthesia, general, Immunity, Tongue neoplasms, immune, general anesthesia
- Medical subject headings
- Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous anesthesiaProcedure or surgery
intravenous anesthesia
combined intravenous-inhalational anesthesiaProcedure or surgery
combined intravenous-inhalational anesthesia
inhalational anesthesiaProcedure or surgery
inhalational anesthesia
| Study group | Role | What they receive |
|---|---|---|
| inhalational anesthesia | Experimental | inhalational anesthesia Receives: Procedure: inhalational anesthesia |
| combined intravenous-inhalational anesthesia | Experimental | combined intravenous-inhalational anesthesia Receives: Procedure: combined intravenous-inhalational anesthesia |
| intravenous anesthesia | Experimental | intravenous anesthesia Receives: Procedure: intravenous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of immune cells
30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation
Measured: 3 days
Secondary outcomes (3)
Percentages of T lymphocytes subsets
30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation
Measured: 3 days
Percentages of Natural Killer cells
30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation
Measured: 3 days
Percentages of B lymphocytes
30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- tiejun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, tiejun Zhang, Wuhan University
- Investigators
- kebin Liu, Study director, Master of Department of Anesthesiology of Hospital of Stomatology, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854021
- Sponsor's protocol ID
- wuhan university
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 17 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
- ClinicalTrials.gov ID
- NCT01854021
- Acronym / sponsor ID
- wuhan university
- Conditions
- Tongue Cancer
- Keywords
- Anesthesia, general, Immunity, Tongue neoplasms, immune, general anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- tiejun ZhangUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (estimated)
- First posted
- 15 May 2013 (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.
Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced immunosuppression has been implicated in the development of post-operative septic complications and neoplasm metastasis. General anesthesia is considered to not only suppress surgical stress, but also affect the immune function directly，such as altering the number and activity of immune cells. It is reported that some anesthetics increase susceptibility to tumor metastasis, apparently by suppressing natural killer cell activity. Different anesthetic techniques and anesthetics used in anesthesia have shown different effects on immunity. Many of the studies were animal trials or performed in vitro; in addition, most are focused on a single drug. To date, there is little published prospective clinical research designed specifically to investigate the effects of different general anesthetic technique on immune function in patients with oral malignant tumors. The aim of this study is going to characterize the immune response of patients undergoing surgery for tongue cancer under 3 types of general anesthesia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inhalational anesthesia | Experimental | Procedure: inhalational anesthesiainhalational anesthesia |
| combined intravenous-inhalational anesthesia | Experimental | Procedure: combined intravenous-inhalational anesthesiacombined intravenous-inhalational anesthesia |
| intravenous anesthesia | Experimental | Procedure: intravenous anesthesiaintravenous anesthesia |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All the patients were scheduled for elective surgery for tongue cancer under general anesthesia. None of the patients had a history of endocrine, immune and circulatory system diseases;
- Exclusion criteria were also contraindications for receiving chemotherapy
Key exclusion criteria (5 listed)
- contraindications for receiving chemotherapy,
- receiving perioperative blood transfusion, or
- preoperative and perioperative treatment with hormones and immunomodulatory agent.
- Patients who suffered from any surgical complications such as infection were also excluded from our study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous anesthesiaintravenous anesthesia | Procedure or surgery | intravenous anesthesia |
| combined intravenous-inhalational anesthesiacombined intravenous-inhalational anesthesia | Procedure or surgery | combined intravenous-inhalational anesthesia |
| inhalational anesthesiainhalational anesthesia | Procedure or surgery | inhalational anesthesia |
Primary outcome
Percentages of immune cells
Time frame: 3 days
30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation
3 secondary outcomes
Percentages of T lymphocytes subsets
Time frame: 3 days
Percentages of Natural Killer cells
Time frame: 3 days
Percentages of B lymphocytes
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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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.
kebin Liu study director
Master of Department of Anesthesiology of Hospital of Stomatology, Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous anesthesia, combined intravenous-inhalational anesthesia and inhalational anesthesia in people with Tongue Cancer, run by tiejun Zhang at 1 site in China.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 May 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tiejun zhang, M.D. (8602787686219, ztj@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of immune cells (time frame: 3 days). 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 17 May 2013.