Head and Neck CancerNCT04700475
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
A study testing low level laser and citric acid solution in people with Head and Neck Cancer, run by Nada Yousef at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the effectiveness of low level laser on radiotherapy induced xerostomia to improve oral function and decrease oral complication due to hyposalivation and thus enhancing survival. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- low level laser and citric acid solution
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2020to Feb 2021
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Age range between 25-55 years.
- All patients included in the study established HNC and will receive radiotherapy encompassing major salivary glands accompanied or not by surgery.
- All patients enrolled to the study will have their informed consent.
- Both genders will participate in the study.
- All the patients were examined medically by oncologist
Who cannot join
- - Diabetes mellitus,
- Autoimmune diseases as sjorgen syndrome by established diagnosis criteria.
- Infectious diseases
- Collagen diseases, as were those with incipient tumors (stage T1 or T2) limited to the larynx, as well as those with trismus (reduced mouth opening capacity) due to surgical sequelae.
- xerostomic drugs (antiretroviral medications, antihistamines, anticholinergics, antihypertensives, decongestants, narcotic analgesics, tricyclic antidepressants)
Trial locations and contacts
1 site in 1 country.
Mohamed M. Mosaad, bachelor contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Giza
Nada M. Yousef, master, 01002010168 ext. 01069207280, dr.nada123.ny@gmail.com
About this study
The purpose of the study is to evaluate the effectiveness of low level laser on radiotherapy induced xerostomia to improve oral function and decrease oral complication due to hyposalivation and thus enhancing survival.
Read the detailed description
In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures.
- Subjects: Sixty patients who have head and neck cancer (oral cavity, pharynx, larynx, or occult primary tumor) submitted to conventional 3D radiotherapy, with irradiation fields necessarily encompassing all major salivary glands. The total dose ranged from 66 to 70 Gy, given in fractions of 2 Gy/day selected randomly from Nuclear medicine department, Oncology institute, Mansoura University. These patients will be divided randomly into two groups of equal number, thirty patients for each group. Group A: (Laser group) This group of patients composes of thirty patients who will receive GaAlAs laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions (Fernanda A. S.G. et al., 2016). Group B :( Control group) This group of patients composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec (Bozana Loncar, D.M.D. et al., 2010) . The criteria of Patients selection :
- Equipment used:
1-Therapeutic equipment: Laser therapy will be performed with an GaAlAs laser
2- Evaluation tools:
- Unstimulated and stimulated saivery flow rate.
- Salivery immunoglobin A (sIgA) concentration in unstimulated saliva
- The 11-item modified Xerostomia Inventory-Dutch questionnaire version 22.
- Conditions
- Head and Neck Cancer
- Being tested
- low level laser, citric acid solution
- Keywords
- Low level laser, Xerostomia, Radiotherapy, Head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laserDevice
Also called cold or non invasive laser
Laser will be performed with a GaAlAs diode laser at a wavelength of 808 nm, 100-mW output power, laser beam area of 0.03 cm2, and in continuous wave mode, three times a week, on alternate days. Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions.
The total energy per session (56 J) will be divided into 14 irradiation points, as marked on the overlying skin (Fig.2). Each irradiation point received a dose of 4 J over an irradiation time of 40 s.
With exclusion of tumor area or area of removed tumor laser will be applied as following:
- Extra oral application: The laser will be used extraorally at eight points in the parotid glands (bilaterally, four points in each gland), at four points in the submandibular glands (bilaterally, two points in each gland
- Intraoral application: The will be used intraorally at two points in the sublingual glands bilaterally, one point in each gland .
citric acid solutionDrug
citric acid solution applied as a mouth rinse
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Experimental | Laser group composes of thirty patients who will receive low level laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions Receives: Device: low level laser; Drug: citric acid solution |
| Control group | Other | control group composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec Receives: Drug: citric acid solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unstimulated and stimulated salivary flow rate.
For the assessment of salivary flow rate, unstimulated and stimulated sialometry tests will be performed before the first radiotherapy session and after completion of laser programe.
As salivary secretion fluctuates between minimal and maximal rates during the day, it is important to assess the salivary secretion consistently at an established time of the day, in order to properly examine the evolution of the condition and its treatment in every patient.
The normal flow rate for unstimulated, "resting" whole saliva is 0.3 to 0.5 ml/min.; for stimulated saliva, 1 to 2 ml/min. Values less than 0.1 ml/min. are typically considered xerostomic, although reduced flow may not always be associated with complaints of dryness
Measured: 7 weeks
Secondary outcomes (1)
Salivary immunoglobin A (sIgA) concentration in unstimulated saliva.
The samples of unstimulated whole saliva will be frozen and stored at -20°C until used for sIgA determination. sIgA concentrations were measured by using commercially available indirect competitive enzyme immunoassay kit (Salivary SIgA EIA kit, Salimetrics).
The quantities of salivary IgA secreted in 5 minutes will be calculated by taking in account sIgA concentrations and volumes of unstimulated saliva secreted in 5 minutes.
Measured: 7weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start4 Sep 2020
- Primary completion1 Nov 2020
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, 2 groups of patients will participate First, study group will recieve low level laser on major salivary glands and usual medications. Second, control group will recieve usual medications. Second, control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nada Yousef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nada Yousef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700475
- Sponsor's protocol ID
- P.T.REC/012/002269
- Status last verified
- Jan 2021
- First submitted
- 29 Sep 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
- ClinicalTrials.gov ID
- NCT04700475
- Acronym / sponsor ID
- P.T.REC/012/002269
- Conditions
- Head and Neck Cancer
- Keywords
- Low level laser, Xerostomia, Radiotherapy, Head and neck cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nada YousefUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- Feb 2021 (estimated)
- First posted
- 8 Jan 2021 (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.
The purpose of the study is to evaluate the effectiveness of low level laser on radiotherapy induced xerostomia to improve oral function and decrease oral complication due to hyposalivation and thus enhancing survival.
Detailed description
In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures.
- Subjects: Sixty patients who have head and neck cancer (oral cavity, pharynx, larynx, or occult primary tumor) submitted to conventional 3D radiotherapy, with irradiation fields necessarily encompassing all major salivary glands. The total dose ranged from 66 to 70 Gy, given in fractions of 2 Gy/day selected randomly from Nuclear medicine department, Oncology institute, Mansoura University. These patients will be divided randomly into two groups of equal number, thirty patients for each group. Group A: (Laser group) This group of patients composes of thirty patients who will receive GaAlAs laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions (Fernanda A. S.G. et al., 2016). Group B :( Control group) This group of patients composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec (Bozana Loncar, D.M.D. et al., 2010) . The criteria of Patients selection :
- Equipment used:
1-Therapeutic equipment: Laser therapy will be performed with an GaAlAs laser
2- Evaluation tools:
- Unstimulated and stimulated saivery flow rate.
- Salivery immunoglobin A (sIgA) concentration in unstimulated saliva
- The 11-item modified Xerostomia Inventory-Dutch questionnaire version 22.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In the study, 2 groups of patients will participate First, study group will recieve low level laser on major salivary glands and usual medications. Second, control group will recieve usual medications. Second, control
| Arm | Type | Receives |
|---|---|---|
| Laser group | Experimental | Device: low level laser, Drug: citric acid solutionLaser group composes of thirty patients who will receive low level laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions |
| Control group | Other | Drug: citric acid solutioncontrol group composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Age range between 25-55 years.
- All patients included in the study established HNC and will receive radiotherapy encompassing major salivary glands accompanied or not by surgery.
- All patients enrolled to the study will have their informed consent.
- Both genders will participate in the study.
- All the patients were examined medically by oncologist
Key exclusion criteria (5 listed)
- - Diabetes mellitus,
- Autoimmune diseases as sjorgen syndrome by established diagnosis criteria.
- Infectious diseases
- Collagen diseases, as were those with incipient tumors (stage T1 or T2) limited to the larynx, as well as those with trismus (reduced mouth opening capacity) due to surgical sequelae.
- xerostomic drugs (antiretroviral medications, antihistamines, anticholinergics, antihypertensives, decongestants, narcotic analgesics, tricyclic antidepressants)
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 |
|---|---|---|
| low level laserAlso: cold or non invasive laserLaser will be performed with a GaAlAs diode laser at a wavelength of 808 nm, 100-mW output power, laser beam area of 0.03 cm2, and in continuous wave mode, three times a week, on alternate days. Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions. The total energy per session (56 J) will be divided into 14 irradiation points, as marked on the overlying skin (Fig.2). Each irradiation point received a dose of 4 J over an irradiation time of 40 s. With exclusion of tumor area or area of removed tumor laser will be applied as following: • Extra oral application: The laser will be used extraorally at eight points in the parotid glands (bilaterally, four points in each gland), at four points in the submandibular glands (bilaterally, two points in each gland • Intraoral application: The will be used intraorally at two points in the sublingual glands bilaterally, one point in each gland . | Device | Laser group |
| citric acid solutioncitric acid solution applied as a mouth rinse | Drug | Control group, Laser group |
Primary outcome
Unstimulated and stimulated salivary flow rate.
Time frame: 7 weeks
For the assessment of salivary flow rate, unstimulated and stimulated sialometry tests will be performed before the first radiotherapy session and after completion of laser programe. As salivary secretion fluctuates between minimal and maximal rates during the day, it is important to assess the salivary secretion consistently at an established time of the day, in order to properly examine the evolution of the condition and its treatment in every patient. The normal flow rate for unstimulated, "resting" whole saliva is 0.3 to 0.5 ml/min.; for stimulated saliva, 1 to 2 ml/min. Values less than 0.1 ml/min. are typically considered xerostomic, although reduced flow may not always be associated with complaints of dryness
1 secondary outcome
Salivary immunoglobin A (sIgA) concentration in unstimulated saliva.
Time frame: 7weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 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.
Mohamed M. Mosaad, bachelor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser and citric acid solution in people with Head and Neck Cancer, run by Nada Yousef at 1 site in Egypt.
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 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 8 Jan 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 Egypt. 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 Nada M. Yousef, master (01002010168 ext. 01069207280, dr.nada123.ny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unstimulated and stimulated salivary flow rate. (time frame: 7 weeks). 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 8 Jan 2021.