Nasopharyngeal CarcinomaNCT03788499

Using Massage of Maxillofacial and Oral Cavity to Prevent Radioactive Oral Mucositis

A study testing Massage of Maxillofacial and Oral Cavity in people with Nasopharyngeal Carcinoma, run by Xinqiao Hospital of Chongqing at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A total of 160 cases of nasopharyngeal carcinoma patients who met the inclusion criteria were randomly assigned to two groups. The experimental group was given massage of maxillofacial and oral cavity plus routine oral care and functional exercise. The control group was given routine oral care and functional exercise. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Nasopharyngeal Carcinoma
What is being tested?: Massage of Maxillofacial and Oral Cavity
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 2 sitesChina
Study dates: 11 Jan 2019to 30 Jul 2020
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed by pathology with nasopharyngeal carcinoma;
ECOG PS: 0-2;
Gender is not limited, Age between 18 years old and 70 years old.
Clear consciousness, no mental illness or cognition impairment;
The expected survival time is more than 12 months;

Who cannot join

Patients with other severe diseases affecting the quality of life or the treatment process;
Unwilling to actively cooperate with investigators;
Patients with previous oral diseases;
Patients who have received head and neck surgery and radiotherapy;
A history of psychotropic substance abuse or a mental disorder;
Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment;
Women who are pregnant or in lactation;
Other situations that may affect the results of the clinical study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, 400000
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, 40037

Other trials in China

About this study

Official title: Randomized, Controlled Clinical Study of Using Massage of Maxillofacial and Oral Cavity to Prevent Oral Mucositis in Patients With Nasopharyngeal Carcinoma Undergoing Radiotherapy

Read the detailed description

160 nasopharyngeal carcinoma patients were enrolled and randomly assigned to two groups in a 1:1 ratio. The experimental group was given massage of maxillofacial and oral cavity plus routine oral care and functional exercise, the control group was only given routine oral care and functional exercise. Assess the condition of oral mucosa, according to the grading standard of RTOG acute radiation injury, everyday during radiotherapy. After radiotherapy, follow up the condition of oral mucosa one time per month for a total three times. Then analyze the incidence difference between two groups.

massage method：The duration of the massage lasts from the first day of radiotherapy to three months after the end of radiotherapy，5 times a day（After getting up, before breakfast, lunch, dinner and going to bed). massage of maxillofacial includes the left and right cheeks, the upper jaw, the lower jaw, and around the mouth. Oral Massage includes the tongue, hard palate, the gums, and the bucca. Each part lasts 1-2min，repeating 3 cycles each time. Patients who could finished at least 75% are included in the statistical analysis.

Conditions: Nasopharyngeal Carcinoma
Being tested: Massage of Maxillofacial and Oral Cavity
Keywords: Massage, Maxillofacial and Oral Cavity, Radioactive Oral Mucositis, Nasopharyngeal Carcinoma
Medical subject headings: Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Massage of Maxillofacial and Oral CavityOther
Massage of Maxillofacial and Oral Cavity is performed five times a day, each part lasts 1-2 minutes, repeating 3 cycles. The maxillofacial and oral massage last from the first day of radiotherapy to three months after last radiotherapy.

Study groups in NCT03788499
Study group	Role	What they receive
Control arm	No intervention	routine oral care and functional exercise.
Massage arm	Experimental	Massage of Maxillofacial and oral cavity plus routine oral care and functional exercise Receives: Other: Massage of Maxillofacial and Oral Cavity

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of severe radioactive oral mucositis
the status of oral mucosa was evaluated daily during radiotherapy. According to the grading standard of RTOG acute radiation injury, statistical analysis was made on whether there was a difference and statistical significance in the incidence rate of oral mucositis with radiation above grade 3 between the two groups.
Measured: 3 months

Secondary outcomes (1)

the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 201930 Jul 2020

First posted27 Dec 2018
Study start11 Jan 2019
Primary completion30 Jul 2020
Study completion30 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasopharyngeal CarcinomaStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03788499
Sponsor's protocol ID: XQonc-009
Status last verified: Feb 2024
First submitted: 25 Dec 2018
Last updated: 23 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
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P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
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Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
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RecruitingPhase 1/2
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All Nasopharyngeal Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled Clinical Study of Using Massage of Maxillofacial and Oral Cavity to Prevent Oral Mucositis in Patients With Nasopharyngeal Carcinoma Undergoing Radiotherapy
ClinicalTrials.gov ID: NCT03788499
Acronym / sponsor ID: XQonc-009
Conditions: Nasopharyngeal Carcinoma
Keywords: Massage, Maxillofacial and Oral Cavity, Radioactive Oral Mucositis, Nasopharyngeal Carcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Xinqiao Hospital of ChongqingUniversity, hospital or other
Study start: 11 Jan 2019 (actual)
Primary completion: 30 Jul 2020 (actual)
Study completion: 30 Jul 2020 (actual)
First posted: 27 Dec 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Control arm	No intervention	–routine oral care and functional exercise.
Massage arm	Experimental	Other: Massage of Maxillofacial and Oral CavityMassage of Maxillofacial and oral cavity plus routine oral care and functional exercise

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients diagnosed by pathology with nasopharyngeal carcinoma;
ECOG PS: 0-2;
Gender is not limited, Age between 18 years old and 70 years old.
Clear consciousness, no mental illness or cognition impairment;
The expected survival time is more than 12 months;

Key exclusion criteria (8 listed)

Patients with other severe diseases affecting the quality of life or the treatment process;
Unwilling to actively cooperate with investigators;
Patients with previous oral diseases;
Patients who have received head and neck surgery and radiotherapy;
A history of psychotropic substance abuse or a mental disorder;

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
Massage of Maxillofacial and Oral CavityMassage of Maxillofacial and Oral Cavity is performed five times a day, each part lasts 1-2 minutes, repeating 3 cycles. The maxillofacial and oral massage last from the first day of radiotherapy to three months after last radiotherapy.	Other	Massage arm

Primary outcome

Incidence of severe radioactive oral mucositis
Time frame: 3 months
the status of oral mucosa was evaluated daily during radiotherapy. According to the grading standard of RTOG acute radiation injury, statistical analysis was made on whether there was a difference and statistical significance in the incidence rate of oral mucositis with radiation above grade 3 between the two groups.

1 secondary outcome

the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
Time frame: 3 months

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 23 Feb 2024.

Related trials for Nasopharyngeal Carcinoma

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Massage of Maxillofacial and Oral Cavity in people with Nasopharyngeal Carcinoma, run by Xinqiao Hospital of Chongqing at 2 sites 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 5 inclusion and 8 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 23 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 2 sites 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?

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?

Incidence of severe radioactive oral mucositis (time frame: 3 months). 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 NCT03788499.

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 23 Feb 2024.