Malignant Tumor of Head and/or NeckNCT06272617
Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer
A study testing verum acupuncture in people with Malignant Tumor of Head and/or Neck and Radiotherapy; Complications, run by West China Hospital at 1 site in China.
Trial summary
A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumor of Head and/or Neck, Radiotherapy; Complications
- What is being tested?
- verum acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2023to 24 Jul 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with malignant tumors of the head and neck without metastasis
- Age ≥18, ≤80 years old
- ZPS score ≤2
- Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy, including at least one parotid gland
- Judged to be able to receive acupuncture treatment, with all needle positions identified as accessible
- Signed informed consent form
Who cannot join
- History of dry mouth, Sjogren's syndrome, or other underlying systemic condition known to cause dry mouth
- Suspected or confirmed physical closure of both salivary gland ducts
- Have a phobia of needles or prohibit the use of acupuncture at any acupuncture points
- Have a history of head and neck radiotherapy
- Have contraindications to acupuncture, including but not limited to bleeding disorders, having skin infections, ulcers or frequent infections
- Have taken any medications or herbs within the past 30 days that may affect salivary function, plan to or eventually take such substances during the study period
Show all 9Show fewer
- Poor oral hygiene or severe periodontitis
- Poor compliance
- Other patients who, in the opinion of the investigator, are not suitable for participation in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Xingchen Peng, 0086-18980606753, pxx2014@scu.edu.cn
About this study
Official title: A Single-center, Single-blind Phase II Clinical Trial of Acupuncture for the Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Malignant Tumors
A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
Read the detailed description
The goal of this clinical trial is to investigate the efficacy and safety of acupuncture for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main questions it aims to answer are:
- the efficacy of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
- the safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
Participants will:
- be treated with real acupuncture or sham acupuncture
- be evaluated to learn the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
Researchers will compare real acupuncture group with sham acupuncture group to see if acupuncture has good efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors.
- Being tested
- verum acupuncture, sham acupuncture
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verum acupunctureDevice
a type of acupuncture which is useful
sham acupunctureDevice
a type of acupuncture which is useless
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | verum acupuncture Receives: Device: verum acupuncture |
| control group | Sham comparator | sham acupuncture Receives: Device: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerostomia questionnaire scores
Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms
Measured: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Secondary outcomes (12)
Salivary flow rate
Researchers-measured unstimulated and stimulated salivary flow rates;Lower value indicates more severe symptoms
Measured: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by patients
Assessed by Patients self-evaluated dysgeusia(score 19-95);Higher score indicates more severe symptoms
Measured: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by electrogustometer test
Assessed by electrogustometer test(score -6 to 34);Higher score indicates more severe symptoms
Measured: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by taste strips test
Assessed by taste strips test(score 0-16);Lower score indicates more severe symptoms
Measured: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Oral mucositis
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale(grade 1-5);Higher grade indicates more severe symptoms
Measured: 1 week before radiotherapy;twice a week during the treatment(usually every 3 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Dysphagia
Dysphagia is assessed by M.D.Anderson Dysphagia Inventory(score 20-100);Lower score indicates more severe symptoms
Measured: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Quality of Life assessed by EORTC QLQ-C30
Quality of Life is assessed by EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire);transformed into 0-100 scales for different domains and symptoms;Higher domain scores represent better quality of life, while higher symptom scores represent worse quality of life
Measured: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Quality of Life assessed by QLQ-H&N35
Quality of Life is assessed by QLQ-H\&N35(Head and neck cancer-related quality of life scale);transformed into 0-100 scales for different domains and symptoms;Higher scores represent worse quality of life
Measured: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Adverse effects
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version(grade 1-5);Higher grade indicates more severe symptoms
Measured: up to 12 months
Changes of oral flora
The changes of oral flora in patients' salivary or oral swab measured by 16s rDNA technique
Measured: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Tongue range of motion
Assessed by Tongue Range of Motion Assessment Scale(score 0-100);Lower score indicates more severe symptoms
Measured: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Neck Fibrosis
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version:Fibrosis skin(grade 1-5);Higher grade indicates more severe symptoms
Measured: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the 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 posted22 Feb 2024
- Study start25 Jul 2023
- Primary completion24 Jul 2024 (estimated)
- Study completion24 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumor of Head and/or NeckStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272617
- Sponsor's protocol ID
- 2023-960
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-blind Phase II Clinical Trial of Acupuncture for the Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Malignant Tumors
- ClinicalTrials.gov ID
- NCT06272617
- Acronym / sponsor ID
- 2023-960
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 24 Jul 2024 (estimated)
- Study completion
- 24 Jul 2025 (estimated)
- First posted
- 22 Feb 2024 (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.
A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
Detailed description
The goal of this clinical trial is to investigate the efficacy and safety of acupuncture for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main questions it aims to answer are:
- the efficacy of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
- the safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
Participants will:
- be treated with real acupuncture or sham acupuncture
- be evaluated to learn the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
Researchers will compare real acupuncture group with sham acupuncture group to see if acupuncture has good efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: verum acupunctureverum acupuncture |
| control group | Sham comparator | Device: sham acupuncturesham acupuncture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with malignant tumors of the head and neck without metastasis
- Age ≥18, ≤80 years old
- ZPS score ≤2
- Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy, including at least one parotid gland
- Judged to be able to receive acupuncture treatment, with all needle positions identified as accessible
Key exclusion criteria (9 listed)
- History of dry mouth, Sjogren's syndrome, or other underlying systemic condition known to cause dry mouth
- Suspected or confirmed physical closure of both salivary gland ducts
- Have a phobia of needles or prohibit the use of acupuncture at any acupuncture points
- Have a history of head and neck radiotherapy
- Have contraindications to acupuncture, including but not limited to bleeding disorders, having skin infections, ulcers or frequent infections
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 |
|---|---|---|
| verum acupuncturea type of acupuncture which is useful | Device | treatment group |
| sham acupuncturea type of acupuncture which is useless | Device | control group |
Primary outcome
Xerostomia questionnaire scores
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms
12 secondary outcomes
Salivary flow rate
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by patients
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by electrogustometer test
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by taste strips test
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Oral mucositis
Time frame: 1 week before radiotherapy;twice a week during the treatment(usually every 3 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Dysphagia
Time frame: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Quality of Life assessed by EORTC QLQ-C30
Time frame: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Quality of Life assessed by QLQ-H&N35
Time frame: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Adverse effects
Time frame: up to 12 months
Changes of oral flora
Time frame: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Tongue range of motion
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Neck Fibrosis
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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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.
Xingchen Peng study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verum acupuncture in people with Malignant Tumor of Head and/or Neck and Radiotherapy; Complications, 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 6 inclusion and 9 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 22 Feb 2024. 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.
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 Xingchen Peng (+8618980606753, pxx2014@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerostomia questionnaire scores (time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end 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 22 Feb 2024.