Patients Undergoing Open Thyroid SurgeryPhase 3MIRENNCT07274696
Mecobalamin in Promoting Recurrent Laryngeal Nerve Function Recovery After Thyroid Surgery
A Phase 3 study testing Mecobalamin in people with Patients Undergoing Open Thyroid Surgery, run by West China Hospital at 1 site in China.
Trial summary
Recurrent laryngeal nerve injury is one of the most common and serious complications affecting quality of life after thyroid surgery. Intraoperative traction, clamping, thermal injury, or direct transection can lead to its dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients Undergoing Open Thyroid Surgery
- What is being tested?
- Mecobalamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years (inclusive) Scheduled to undergo thyroid surgery (including thyroid gland and isthmus resection, total thyroidectomy, etc.) Preoperative laryngoscopy confirms normal bilateral vocal cord mobility Intraoperative neuromonitoring (IONM) technology is used in all cases Voluntarily and capable of providing signed informed consent.
Who cannot join
- Pre-existing hoarseness or recurrent laryngeal nerve palsy Planned surgery limited to the thyroid isthmus only, or the isthmus plus the medial one-third of both lobes Pre-existing severe peripheral neuropathy due to other causes (e.g., diabetes mellitus, alcoholism) Pregnant or lactating women Chronic use of high-dose vitamin B12 or other neurotrophic drugs Conditions interfering with drug administration or absorption (e.g., dysphagia, intestinal obstruction) Severe pre-existing comorbidities with intolerance to general anesthesia or surgery History of vitamin B12 allergy Concurrent participation in another clinical study that may interfere with this trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China hospital of Sichuan University
Chengdu, Sichuan, 610041
Jianyong Lei, +86 19983137992, leijianyong@scu.edu.cn
Yu Feng, +86 15183042703, 1350502131@qq.com
About this study
Official title: A Multicenter, Open-Label, Randomized, Placebo-Controlled Study Protocol on the Effect of Mecobalamin in Promoting Recurrent Laryngeal Nerve Function Recovery After Thyroid Surgery（MIREN Trial）
Recurrent laryngeal nerve injury is one of the most common and serious complications affecting quality of life after thyroid surgery. Intraoperative traction, clamping, thermal injury, or direct transection can lead to its dysfunction. Unilateral injury causes vocal cord paralysis, manifesting as hoarseness, coughing while drinking, and vocal fatigue; bilateral injury can result in severe dyspnea, potentially requiring tracheotomy and posing life-threatening risks. Although intraoperative neuromonitoring has reduced the risk of permanent injury, temporary nerve palsy remains very common, imposing a dual physiological and psychological burden on patients. Therefore, exploring safe and effective methods to promote the recovery of recurrent laryngeal nerve function postoperatively is an urgent clinical issue in thyroid surgery.
As a motor nerve, the functional recovery of the recurrent laryngeal nerve depends on axonal regeneration and reinnervation of the laryngeal muscles. This process is slow and often incomplete, influenced by factors such as the extent of injury and patient age. Current clinical management of postoperative recurrent laryngeal nerve palsy primarily involves conservative observation and voice training, lacking proactive pharmacological interventions. This presents a clear rationale and clinical entry point for research.
Read more
Mecobalamin, the active form of vitamin B12, has high bioavailability and directly participates in methylation reactions, as well as nucleic acid and protein synthesis. Studies have confirmed its multifaceted role in treating peripheral neuropathy: (1) It promotes myelin regeneration by enhancing Erk1/2 and Akt activity, accelerating the myelination of damaged nerve fibers; (2) It enhances nerve regeneration by promoting the synthesis and secretion of nerve growth factors; (3) It improves nerve cell metabolism and repairs damaged nerve cell membranes; (4) It exerts neurotrophic effects by stimulating the proliferation and activity of Schwann cells, thereby increasing the secretion of neurotrophic factors and optimizing the microenvironment for nerve regeneration.
Although mecobalamin is theoretically beneficial for nerve repair and has been successfully applied in other neuropathies, high-quality clinical studies specifically targeting its use for recurrent laryngeal nerve recovery after thyroid surgery are still lacking. Existing literature consists mostly of small-sample retrospective analyses or case reports with inconsistent conclusions and limitations such as selection bias and inadequate control of confounding factors. There is a lack of large-sample, multicenter, randomized controlled trials to provide high-level evidence-based medical data.
Based on this background, the investigators plan to conduct a nationwide multicenter, randomized controlled study. The primary endpoint will be objective acoustic parameters measured by computerized voice analysis, while secondary endpoints will include patient-reported quality of life outcomes, time to voice recovery, subjective patient satisfaction, incidence of permanent paralysis, and adverse drug reactions. The study aims to scientifically and objectively evaluate the efficacy and safety of mecobalamin in promoting the recovery of recurrent laryngeal nerve function after thyroid cancer surgery, providing new therapeutic strategies to optimize perioperative management and improve the quality of life for patients.
Read the detailed description
This study is a multicenter, open-label, randomized controlled trial. Inclusion Criteria: (1) Patients aged 18-75 years (inclusive); (2) Scheduled to undergo thyroid surgery (including thyroid gland and isthmus resection, total thyroidectomy, etc.); (3) Preoperative laryngoscopy confirms normal bilateral vocal cord mobility; (4) Intraoperative neuromonitoring (IONM) technology is used in all cases; (5) Voluntarily and capable of providing signed informed consent. Exclusion Criteria: (1) Pre-existing hoarseness or recurrent laryngeal nerve palsy; (2) Planned surgery limited to the thyroid isthmus only, or the isthmus plus the medial one-third of both lobes; (3) Pre-existing severe peripheral neuropathy due to other causes (e.g., diabetes mellitus, alcoholism); (4) Pregnant or lactating women; (5) Chronic use of high-dose vitamin B12 or other neurotrophic drugs; (6) Conditions interfering with drug administration or absorption (e.g., dysphagia, intestinal obstruction); (7) Severe pre-existing comorbidities with intolerance to general anesthesia or surgery; (8) History of vitamin B12 allergy; (9) Concurrent participation in another clinical study that may interfere with this trial.
Eligible patients will be randomly assigned in a 1:1 ratio to either the experimental group (Mecobalamin group) or the control group (control group). Data to be collected includes: (1) Basic Information: Name, randomization number, treating hospital, hospital admission number, group assignment, phone number, age, height, weight, BMI, comorbidities (cardiovascular, endocrine, thyroid diseases, etc.); (2) Preoperative Imaging and Laboratory Data: Laryngoscopy results, thyroid ultrasound, electrocardiogram (ECG), TSH, FT3, FT4, TT3, TT4, Tg, TgAb; (3) Surgical Data: Diagnosis, operating surgeon, surgical procedure, surgery date, intraoperative complications, intraoperative signal changes of the vagus nerve, recurrent laryngeal nerve, and superior laryngeal nerve; (4) Voice Assessments (Preoperative, Postoperative Day 1, Postoperative 1 month, 3 months, 6 months): Objective acoustic parameters of voice quality, Voice Handicap Index-10 (VHI-10), Voice-Related Quality of Life-10 (V-RQOL-10), subjective perceptual evaluation of voice quality (GRBAS scale); (5) Postoperative Pathological Results: Postoperative pathological TNM staging, postoperative pathological diagnosis, postoperative treatment; (6) Surgical Complications: Whether secondary surgery was required due to complications; (7) Postoperative Mecobalamin/Placebo Usage: Dosage, course duration, adverse drug events.
- Conditions
- Patients Undergoing Open Thyroid Surgery
- Being tested
- Mecobalamin, placebo
- Keywords
- thyroid surgery, recurrent laryngeal nerve, mecobalamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MecobalaminDrug
The patient began taking mecobalamin tablets orally within 24 hours after thyroid surgery, three times a day, 0.5mg each time, for three consecutive months.
placeboDrug
The patient was given a placebo within 24 hours after thyroid surgery, which was identical in appearance, size, color, dosage form, weight, taste, and smell to mecobalamin tablets, three times a day, 0.5mg each time, for three consecutive months.
| Study group | Role | What they receive |
|---|---|---|
| Mecobalamin Group | Experimental | The patient began taking mecobalamin tablets orally within 24 hours after thyroid surgery, three times a day, 0.5mg each time, for three consecutive months. Receives: Drug: Mecobalamin |
| Control group | Placebo comparator | The patient was given a placebo within 24 hours after thyroid surgery, which was identical in appearance, size, color, dosage form, weight, taste, and smell to mecobalamin tablets, three times a day, 0.5mg each time, for three consecutive months. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jitter
Jitter reflects the regularity of the voice in terms of frequency. A smaller jitter value indicates higher regularity of the voice in terms of frequency.
Measured: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Shimmer
Shimmer reflects the regularity of the voice in terms of amplitude. A smaller shimmer value indicates higher regularity of the voice in terms of amplitude.
Measured: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Fundamental frequency (F0)
Measured: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Maximum Phonational Frequency Range (MPFR)
The frequency range from the lowest to the highest pitch a person can produce (in Hz or semitones).
Measured: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Noise-to-Harmonic Ratio (NHR)
The NHR parameter is the ratio of non-harmonic components within the 1,500-4,500 Hz range to harmonic components within the 70-4,500 Hz range. It can be used to assess the proportion of noise components in the voice.
Measured: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Secondary outcomes (7)
The Voice Handicap Index-10 (VHI-10)
The VHI-10 is a voice disorder index scale containing 10 items, comprising 5 functional items, 3 physical items, and 2 emotional items. Each item is scored from 0 to 4, with different scores representing the frequency of occurrence for that item: "Never" is 0 points; "Almost Never" is 1 point; "Sometimes" is 2 points; "Almost Always" is 3 points; and "Always" is 4 points. A higher score indicates a greater impact of the voice disorder in that domain and a more severe self-assessment of the voice disorder by the subject. The critical value for the VHI-10 is 8 points, and subjects with a VHI score ≥ 8 are classified as having a voice disorder.
Measured: Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The Voice-Related Quality of Life (V-RQOL-10) scale
Consists of 10 items, encompassing two domains: social-emotional and physical-functioning. The items describe the subjective experiences of patients with voice disorders. Severity is rated on a 5-point scale, where 1 represents "none," 2 represents "a little," 3 represents "a moderate amount," 4 represents "a lot," and 5 represents "a great deal." This questionnaire uses "reverse scoring," and the final scores need to be transformed to a 0 to 100 scale. A higher overall score indicates better voice-related quality of life, while a lower score indicates worse voice-related quality of life.
Measured: Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The subjective auditory-perceptual assessment of voice quality (GRBAS Scale)
This scale consists of five parameters: overall grade of hoarseness (G), roughness (R), breathiness (B), asthenia (A), and strain (S). Each parameter is rated on a severity scale from 0 to 3: 0 indicates normal, 1 indicates mild deviation, 2 indicates moderate deviation, and 3 indicates severe deviation. A higher score represents a more severe voice disorder. The assessment is conducted by professional audiologists, voice specialists, and the patient's family members.
Measured: Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Stroboscopy
This examination utilizes the principle of persistence of vision to observe the vocal cords in a seemingly stationary or slow-motion vibrating state through visual superposition. Dynamic laryngoscopy is performed preoperatively, and the stroboscopic findings are recorded. Postoperatively, it is conducted on patients presenting with voice abnormalities, dysphonia, or suspected abnormal vocal cord mobility to confirm the mobility of the vocal cords.
Measured: Preoperative, If necessary after surgery
Intraoperative neural signals
During the surgery, IONM technology was used to monitor neural signals from the vagus nerve, recurrent laryngeal nerve, and superior laryngeal nerve both before and after nerve exposure.
Measured: Intraoperative
The Eating Assessment Tool (EAT-10)
This instrument consists of 10 questions, with severity rated on a scale from 0 to 4. A score of 0 indicates "no problem," 1 indicates "mild," 2 indicates "moderate," 3 indicates "severe," and 4 indicates "very severe." A total score above 3 is generally considered indicative of abnormal swallowing function.
Measured: Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Adverse Events
At each follow-up visit, adverse events (including adverse drug reactions) were recorded through patient interviews and physical examinations.
Measured: Within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Open Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Tianfu Hospital, Shang Jin Hospital of West China Hospital,Sichuan University, Sichuan Academy of Medical Sciences, Sanya People's Hospital
- Responsible party
- Principal investigator, Yu Feng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274696
- Sponsor's protocol ID
- 2025(2153)
- Acronym
- MIREN
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stojadinovic A, Shaha AR, Orlikoff RF, Nissan A, Kornak MF, Singh B, Boyle JO, Shah JP, Brennan MF, Kraus DH. Prospective functional voice assessment in patients undergoing thyroid surgery. Ann Surg. 2002 Dec;236(6):823-32. doi: 10.1097/00000658-200212000-00015.
PubMed 12454521Xia Y, Zhu Y, Ling L, Xu F, Yang Y, Ye J, Tan W, Chen Z, Liu Q, Wei W, Zhang J, Zhang A, Zhang L, Song E, Gong C. Effect of methylcobalamin on capecitabine induced hand-foot syndrome in patients with HER2 negative early breast cancer: multicentre, double blind, randomised, placebo controlled, phase 3 trial. BMJ. 2025 Sep 11;390:e084290. doi: 10.1136/bmj-2025-084290.
PubMed 40935571Nishimoto S, Tanaka H, Okamoto M, Okada K, Murase T, Yoshikawa H. Methylcobalamin promotes the differentiation of Schwann cells and remyelination in lysophosphatidylcholine-induced demyelination of the rat sciatic nerve. Front Cell Neurosci. 2015 Aug 4;9:298. doi: 10.3389/fncel.2015.00298. eCollection 2015.
PubMed 26300733Kim HA, Mindos T, Parkinson DB. Plastic fantastic: Schwann cells and repair of the peripheral nervous system. Stem Cells Transl Med. 2013 Aug;2(8):553-7. doi: 10.5966/sctm.2013-0011. Epub 2013 Jul 1.
PubMed 23817134Stoll G, Muller HW. Nerve injury, axonal degeneration and neural regeneration: basic insights. Brain Pathol. 1999 Apr;9(2):313-25. doi: 10.1111/j.1750-3639.1999.tb00229.x.
PubMed 10219748Zhou T, Wang X, Zhang J, Zhou E, Xu C, Shen Y, Zou J, Lu W, Su K, Huang W, Yi H, Yin S. Global burden of thyroid cancer from 1990 to 2021: a systematic analysis from the Global Burden of Disease Study 2021. J Hematol Oncol. 2024 Aug 27;17(1):74. doi: 10.1186/s13045-024-01593-y.
PubMed 39192360
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized, Placebo-Controlled Study Protocol on the Effect of Mecobalamin in Promoting Recurrent Laryngeal Nerve Function Recovery After Thyroid Surgery（MIREN Trial）
- ClinicalTrials.gov ID
- NCT07274696
- Acronym / sponsor ID
- MIREN / 2025(2153)
- Conditions
- Patients Undergoing Open Thyroid Surgery
- Keywords
- thyroid surgery, recurrent laryngeal nerve, mecobalamin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- West China Tianfu Hospital, Shang Jin Hospital of West China Hospital,Sichuan University, Sichuan Academy of Medical Sciences, Sanya People's Hospital
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 10 Dec 2025 (actual)
- 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.
Recurrent laryngeal nerve injury is one of the most common and serious complications affecting quality of life after thyroid surgery. Intraoperative traction, clamping, thermal injury, or direct transection can lead to its dysfunction. Unilateral injury causes vocal cord paralysis, manifesting as hoarseness, coughing while drinking, and vocal fatigue; bilateral injury can result in severe dyspnea, potentially requiring tracheotomy and posing life-threatening risks. Although intraoperative neuromonitoring has reduced the risk of permanent injury, temporary nerve palsy remains very common, imposing a dual physiological and psychological burden on patients. Therefore, exploring safe and effective methods to promote the recovery of recurrent laryngeal nerve function postoperatively is an urgent clinical issue in thyroid surgery.
As a motor nerve, the functional recovery of the recurrent laryngeal nerve depends on axonal regeneration and reinnervation of the laryngeal muscles. This process is slow and often incomplete, influenced by factors such as the extent of injury and patient age. Current clinical management of postoperative recurrent laryngeal nerve palsy primarily involves conservative observation and voice training, lacking proactive pharmacological interventions. This presents a clear rationale and clinical entry point for research.
Mecobalamin, the active form of vitamin B12, has high bioavailability and directly participates in methylation reactions, as well as nucleic acid and protein synthesis. Studies have confirmed its multifaceted role in treating peripheral neuropathy: (1) It promotes myelin regeneration by enhancing Erk1/2 and Akt activity, accelerating the myelination of damaged nerve fibers; (2) It enhances nerve regeneration by promoting the synthesis and secretion of nerve growth factors; (3) It improves nerve cell metabolism and repairs damaged nerve cell membranes; (4) It exerts neurotrophic effects by stimulating the proliferation and activity of Schwann cells, thereby increasing the secretion of neurotrophic factors and optimizing the microenvironment for nerve regeneration.
Although mecobalamin is theoretically beneficial for nerve repair and has been successfully applied in other neuropathies, high-quality clinical studies specifically targeting its use for recurrent laryngeal nerve recovery after thyroid surgery are still lacking. Existing literature consists mostly of small-sample retrospective analyses or case reports with inconsistent conclusions and limitations such as selection bias and inadequate control of confounding factors. There is a lack of large-sample, multicenter, randomized controlled trials to provide high-level evidence-based medical data.
Based on this background, the investigators plan to conduct a nationwide multicenter, randomized controlled study. The primary endpoint will be objective acoustic parameters measured by computerized voice analysis, while secondary endpoints will include patient-reported quality of life outcomes, time to voice recovery, subjective patient satisfaction, incidence of permanent paralysis, and adverse drug reactions. The study aims to scientifically and objectively evaluate the efficacy and safety of mecobalamin in promoting the recovery of recurrent laryngeal nerve function after thyroid cancer surgery, providing new therapeutic strategies to optimize perioperative management and improve the quality of life for patients.
Detailed description
This study is a multicenter, open-label, randomized controlled trial. Inclusion Criteria: (1) Patients aged 18-75 years (inclusive); (2) Scheduled to undergo thyroid surgery (including thyroid gland and isthmus resection, total thyroidectomy, etc.); (3) Preoperative laryngoscopy confirms normal bilateral vocal cord mobility; (4) Intraoperative neuromonitoring (IONM) technology is used in all cases; (5) Voluntarily and capable of providing signed informed consent. Exclusion Criteria: (1) Pre-existing hoarseness or recurrent laryngeal nerve palsy; (2) Planned surgery limited to the thyroid isthmus only, or the isthmus plus the medial one-third of both lobes; (3) Pre-existing severe peripheral neuropathy due to other causes (e.g., diabetes mellitus, alcoholism); (4) Pregnant or lactating women; (5) Chronic use of high-dose vitamin B12 or other neurotrophic drugs; (6) Conditions interfering with drug administration or absorption (e.g., dysphagia, intestinal obstruction); (7) Severe pre-existing comorbidities with intolerance to general anesthesia or surgery; (8) History of vitamin B12 allergy; (9) Concurrent participation in another clinical study that may interfere with this trial.
Eligible patients will be randomly assigned in a 1:1 ratio to either the experimental group (Mecobalamin group) or the control group (control group). Data to be collected includes: (1) Basic Information: Name, randomization number, treating hospital, hospital admission number, group assignment, phone number, age, height, weight, BMI, comorbidities (cardiovascular, endocrine, thyroid diseases, etc.); (2) Preoperative Imaging and Laboratory Data: Laryngoscopy results, thyroid ultrasound, electrocardiogram (ECG), TSH, FT3, FT4, TT3, TT4, Tg, TgAb; (3) Surgical Data: Diagnosis, operating surgeon, surgical procedure, surgery date, intraoperative complications, intraoperative signal changes of the vagus nerve, recurrent laryngeal nerve, and superior laryngeal nerve; (4) Voice Assessments (Preoperative, Postoperative Day 1, Postoperative 1 month, 3 months, 6 months): Objective acoustic parameters of voice quality, Voice Handicap Index-10 (VHI-10), Voice-Related Quality of Life-10 (V-RQOL-10), subjective perceptual evaluation of voice quality (GRBAS scale); (5) Postoperative Pathological Results: Postoperative pathological TNM staging, postoperative pathological diagnosis, postoperative treatment; (6) Surgical Complications: Whether secondary surgery was required due to complications; (7) Postoperative Mecobalamin/Placebo Usage: Dosage, course duration, adverse drug events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mecobalamin Group | Experimental | Drug: MecobalaminThe patient began taking mecobalamin tablets orally within 24 hours after thyroid surgery, three times a day, 0.5mg each time, for three consecutive months. |
| Control group | Placebo comparator | Drug: placeboThe patient was given a placebo within 24 hours after thyroid surgery, which was identical in appearance, size, color, dosage form, weight, taste, and smell to mecobalamin tablets, three times a day, 0.5mg each time, for three consecutive months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-75 years (inclusive) Scheduled to undergo thyroid surgery (including thyroid gland and isthmus resection, total thyroidectomy, etc.) Preoperative laryngoscopy confirms normal bilateral vocal cord mobility Intraoperative neuromonitoring (IONM) technology is used in all cases Voluntarily and capable of providing signed informed consent.
Key exclusion criteria (1 listed)
- Pre-existing hoarseness or recurrent laryngeal nerve palsy Planned surgery limited to the thyroid isthmus only, or the isthmus plus the medial one-third of both lobes Pre-existing severe peripheral neuropathy due to other causes (e.g., diabetes mellitus, alcoholism) Pregnant or lactating women Chronic use of high-dose vitamin B12 or other neurotrophic drugs Conditions interfering with drug administration or absorption (e.g., dysphagia, intestinal obstruction) Severe pre-existing comorbidities with intolerance to general anesthesia or surgery History of vitamin B12 allergy Concurrent participation in another clinical study that may interfere with this trial
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 |
|---|---|---|
| MecobalaminThe patient began taking mecobalamin tablets orally within 24 hours after thyroid surgery, three times a day, 0.5mg each time, for three consecutive months. | Drug | Mecobalamin Group |
| placeboThe patient was given a placebo within 24 hours after thyroid surgery, which was identical in appearance, size, color, dosage form, weight, taste, and smell to mecobalamin tablets, three times a day, 0.5mg each time, for three consecutive months. | Drug | Control group |
Primary outcome
Jitter
Time frame: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Jitter reflects the regularity of the voice in terms of frequency. A smaller jitter value indicates higher regularity of the voice in terms of frequency.
Shimmer
Time frame: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Shimmer reflects the regularity of the voice in terms of amplitude. A smaller shimmer value indicates higher regularity of the voice in terms of amplitude.
Fundamental frequency (F0)
Time frame: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Maximum Phonational Frequency Range (MPFR)
Time frame: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The frequency range from the lowest to the highest pitch a person can produce (in Hz or semitones).
Noise-to-Harmonic Ratio (NHR)
Time frame: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The NHR parameter is the ratio of non-harmonic components within the 1,500-4,500 Hz range to harmonic components within the 70-4,500 Hz range. It can be used to assess the proportion of noise components in the voice.
7 secondary outcomes
The Voice Handicap Index-10 (VHI-10)
Time frame: Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The Voice-Related Quality of Life (V-RQOL-10) scale
Time frame: Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The subjective auditory-perceptual assessment of voice quality (GRBAS Scale)
Time frame: Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Stroboscopy
Time frame: Preoperative, If necessary after surgery
Intraoperative neural signals
Time frame: Intraoperative
The Eating Assessment Tool (EAT-10)
Time frame: Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Adverse Events
Time frame: Within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 12454521Stojadinovic A, Shaha AR, Orlikoff RF, Nissan A, Kornak MF, Singh B, Boyle JO, Shah JP, Brennan MF, Kraus DH. Prospective functional voice assessment in patients undergoing thyroid surgery. Ann Surg. 2002 Dec;236(6):823-32. doi: 10.1097/00000658-200212000-00015.
- Results publication: PubMed 40935571Xia Y, Zhu Y, Ling L, Xu F, Yang Y, Ye J, Tan W, Chen Z, Liu Q, Wei W, Zhang J, Zhang A, Zhang L, Song E, Gong C. Effect of methylcobalamin on capecitabine induced hand-foot syndrome in patients with HER2 negative early breast cancer: multicentre, double blind, randomised, placebo controlled, phase 3 trial. BMJ. 2025 Sep 11;390:e084290. doi: 10.1136/bmj-2025-084290.
- Results publication: PubMed 26300733Nishimoto S, Tanaka H, Okamoto M, Okada K, Murase T, Yoshikawa H. Methylcobalamin promotes the differentiation of Schwann cells and remyelination in lysophosphatidylcholine-induced demyelination of the rat sciatic nerve. Front Cell Neurosci. 2015 Aug 4;9:298. doi: 10.3389/fncel.2015.00298. eCollection 2015.
- Results publication: PubMed 23817134Kim HA, Mindos T, Parkinson DB. Plastic fantastic: Schwann cells and repair of the peripheral nervous system. Stem Cells Transl Med. 2013 Aug;2(8):553-7. doi: 10.5966/sctm.2013-0011. Epub 2013 Jul 1.
- Results publication: PubMed 10219748Stoll G, Muller HW. Nerve injury, axonal degeneration and neural regeneration: basic insights. Brain Pathol. 1999 Apr;9(2):313-25. doi: 10.1111/j.1750-3639.1999.tb00229.x.
- Results publication: PubMed 39192360Zhou T, Wang X, Zhang J, Zhou E, Xu C, Shen Y, Zou J, Lu W, Su K, Huang W, Yi H, Yin S. Global burden of thyroid cancer from 1990 to 2021: a systematic analysis from the Global Burden of Disease Study 2021. J Hematol Oncol. 2024 Aug 27;17(1):74. doi: 10.1186/s13045-024-01593-y.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mecobalamin in people with Patients Undergoing Open Thyroid Surgery, run by West China Hospital 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianyong Lei (+86 19983137992, leijianyong@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jitter (time frame: Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07274696, which also lists 6 linked publications.
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 10 Dec 2025.