UnknownPhase 2

Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy

Spain10 participantsStarted 2018-12-15

Plain-language summary

Phase II not controlled, open-label, prospective, single center clinical trial

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients from 18 to 75 years old of both sexes.
✓. Biochemical analysis without significant alterations which could contraindicate the treatment.
✓. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
✓. 2 years of follow-up without recurrence.
✓. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min.
✓. Grade 1-3 xerostomy as assessed by the grading scale.
✓. The patient is able to understand the nature of the study.
✓. Written informed consent of the patient

Exclusion criteria

✕. Participation in another clinical trial in the 3 months prior to his/her inclusion.
✕. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
✕. Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
✕. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
✕. Xerogenic medication in progress.
✕. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
✕. Local infection.
✕. Pregnancy or pregnancy planned within the next 2 years.

What they're measuring

Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire

Timeframe: 24 months

Changes in the characteristics and degree of discomfort of xerostomia.

Timeframe: 24 months

Sialometry results

Timeframe: 24 months

Restoration of the glandular structure.

Timeframe: 24 months

Restoration of the glandular structure.

Timeframe: 24 months

Restoration of the glandular structure.

Timeframe: 24 months

Measurement of submaxillary gland functionalism changes based on Gammagraphy

Timeframe: 24 months

Trial details

NCT IDNCT03743155

SponsorInstitut de Terapia Regenerativa Tissular

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-30

Contact for this trial

Lluis Orozco, MD

600 421 095 lluis.orozco@itrt.es

View on ClinicalTrials.gov More Xerostomia Due to Radiotherapy trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients from 18 to 75 years old of both sexes.
✓. Biochemical analysis without significant alterations which could contraindicate the treatment.
✓. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
✓. 2 years of follow-up without recurrence.
✓. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min.
✓. Grade 1-3 xerostomy as assessed by the grading scale.
✓. The patient is able to understand the nature of the study.
✓. Written informed consent of the patient

Exclusion criteria

✕. Participation in another clinical trial in the 3 months prior to his/her inclusion.
✕. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
✕. Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
✕. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
✕. Xerogenic medication in progress.
✕. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
✕. Local infection.
✕. Pregnancy or pregnancy planned within the next 2 years.

What they're measuring

Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire

Timeframe: 24 months

Changes in the characteristics and degree of discomfort of xerostomia.

Timeframe: 24 months

Sialometry results

Timeframe: 24 months

Restoration of the glandular structure.

Timeframe: 24 months

Restoration of the glandular structure.

Timeframe: 24 months

Restoration of the glandular structure.

Timeframe: 24 months

Measurement of submaxillary gland functionalism changes based on Gammagraphy

Timeframe: 24 months