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Graft Vs Host DiseaseNCT05018754

Treatment of Oral Mucositis Using Platelet Rich Fibrin TREATMENT OF ORAL MUCOSITIS USING PRF

An observational study of Graft Vs Host Disease and Oral Mucositis (Ulcerative), run by University of Rome Tor Vergata at 1 site in Italy.

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

Oral mucositis (OM) is an inflammatory mucosal demolition frequently observed during treatments for neoplastic diseases such as chemotherapy or radiation therapy. The side effects of these treat-ments often drastically reduce patients' quality of life. Read more about this study

Who is it for?
Any age
What is being tested?
TREATMENT OF ORAL MUCOSITIS USING PLATELET-RICH-FIBRIN (PRF)
How many people
15 participants
Where
1 siteItaly
Study dates
1 Jul 2017to 19 Jul 2021
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients were affected by oral mucositis due to RIOM or chemotherapy.

Who may be able to join

  • All patients were affected by oral mucositis (9 RIOM, 6 chemotherapy-related oral mucositis). They were treated with almost 2 different systemic therapies before and during platelets gel applications. Median of time before the lesions were treated with platelets gel were 7 days. Lesions affected buccal mucosa, tongue, labial commissure and lower lip. Preliminar parameters were the microbiological contamination of lesions and presence of pain.

Who cannot join

  • Systemic Healthy Patients

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Francesco Gianfreda

    Taviano, 73057

Other trials in Italy

About this study

Official title: Treatment of Oral Mucositis Using Platelet Rich Fibrin: a Retrospective Study in Oncological Patients.

Oral mucositis (OM) is an inflammatory mucosal demolition frequently observed during treatments for neoplastic diseases such as chemotherapy or radiation therapy. The side effects of these treat-ments often drastically reduce patients' quality of life.

OM are the result of the systemic consequences of chemotherapy and radiotherapy which, due to their cytotoxic and local effects, lead to pain and severe ulceration with a consequent decrease in the quality of life of affected subjects. Plasma Rich in Fibrin is often used to enhance soft tissue wound healing and fight bacterial sepsis through the presence of leukocytes within it.

Aim of the retrospective study was to evaluate efficacy and safety of topic use of platelet gel in clinical management of oral mucositis in order to improve life quality of patients.

Read the detailed description

Oral mucositis (OM) is a reversible common painful and debilitating iatrogenic lesion due to anti-cancer therapy. Depending on the intensity and dose of chemotherapy or radiotherapy, stomatitis or oral mucositis can significantly contribute to the reduction of patients' quality of life. [1]. The purpose of radiotherapy or chemotherapy therapies is to target rapidly duplicating cells and this triggers unwanted effects on oral and gastrointestinal mucosa, skin, bone marrow, hair follicles, and the tissues adjacent to the target [2].

OM can present with different characteristics of which the most common are edematous and ery-thematous areas, major ulcerations, pain and bleeding. In the most serious cases there is a diffi-culty in drinking, eating and speaking [3]. What is more, in severe cases it can damage patients' quality of life [4-5].

From a biochemical point of view, OM are caused by different molecular patterns such as oxida-tion produced by nitric oxide which causes cell apoptosis or the action of cyclooxygenases, protein kinases, cytokines and nuclear factors. Another interesting aspect to consider is the presence of epigenetic risk factors that target DNA methylation. [6,7] Oral mucositis mainly affects the non-keratinized oral mucosa as it has a cell turnover of 14 days which is twice as fast as keratinized gingiva. The areas of the oral cavity in which it is generally difficult to find this type of lesions are the hard palate, the dorsum of the tongue and the keratin-ized gingiva as they have a slower cell turnover (about 24 days) [8-9] To prevent the manifestation of these side effects, the guidelines of the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology have defined home and professional oral hygiene as the main tool to combat OM, candidiasis and the risk of second-ary infections [10-15]. Care must be taken in removing all those mechanical traumas that can cause iatrogenic lesions such as incongruous margins, incongruous prostheses and grinding bites. However, it is also important to pay attention to all those external agents aggravating oral health such as tobacco, alcohol, oral burns and UV rays for the lips. Zinc supplements have also been suggested to maintain cellular homeostasis or human recombinant Keratinocyte Growth Factor to prevent oral mucositis. [13,16] OM lesions can also lead to large ulcers that can be terribly debilitating for patients. Scientific as-sociations for the protection of cancer patients recognize a key role in pain control and the prophy-laxis or treatment of secondary infections [12-15]. The use of low-intensity laser (Low-Level-Laser Therapy) was also proposed, which thanks to photobiostimulation can enhance tissue healing, re-duce inflammation and limit pain [12-15-17]. Zinc supplements are cofactors for many enzymes maintaining cellular equilibrium, immune response, and wound healing. They are considered an antioxidant, that precludes oxidative damage to many biomolecules [19]. In the most debilitating and painful cases of OM it has been suggested the use of a 2% morphine mouthwash and 0.5% doxepin mouthwash [13]. Furthermore, according to a study by O. Muhammad et al. [20], the glycyrrhetic acid / povidone / sodium hyaluronate gel could provide a mechanical protective action to the mucous membranes with a consequent reduction in pain.

Growth factors have been widely used in various fields of medicine and dentistry with the aim of improving and accelerating healing processes. The use of non-transfusional blood components such as Plasma Rich in Fibrin (PRF) is of great interest as it contains platelets and leukocytes can promote neoangiogenesis, release chemotactic growth factors and some studies have shown that leukocytes have a factor protective even in situations where there may be a risk of osteonecrosis. [21-22] Aim of the study is to evaluate efficacy and safety of topical use of platelet gel rich in fibrin in clinical management and healing of oral mucositis in oncological patients in treatment with chemotherapy and/or radiotherapy.

REFERENCIES:

  1. Sroussi HY, Epstein JB, Bensadoun RJ, et al. Common oral complications of head and neck can-cer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med 2017;6(12):2918-2931. DOI: 10.1002/cam4.122
  2. White S, Pharoah M. Oral radiology: principles and interpretation, 7th ed. St. Louis: Elsevier; 2014
  3. Bensinger W, Schubert M, Ang KK, Brizel D, Brown E, Eilers JG, et al. NCCN task force report. Prevention and management of mucositis in cancer care. J Natl Compr Canc Netw. 2008;6 Suppl 1:S1-21; quiz S22-24
  4. Bensinger W, Schubert M, Ang KK, Brizel D, Brown E, Eilers JG, et al. NCCN task force report. Prevention and management of mucositis in cancer care. J Natl Compr Canc Netw. 2008;6 Suppl 1:S1-21; quiz S22-24
  5. Baharvand M, Sarrafi M, Alavi K, Moghaddam EJ. Efficacy of topical phenytoin on chemothera-py-induced oral mucositis; a pilot study. Daru. 2010;18:46-50
  6. Meyer-Hamme G, Beckmann K, Radtke J, Efferth T, Greten HJ, Rostock M, et al. A survey of chinese medicinal herbal treatment for chemotherapy-induced oral mucositis. Evid Based Com-plement Alternat Med. 2013;2013:284959
  7. Carulli G, Rocco M, Panichi A, Chios CF, Ciurli E, Mannucci C, et al. Treatment of oral mucositis in hematologic patients undergoing autologous or allogeneic transplantation of peripheral blood stem cells: a prospective, randomized study with a mouthwash containing Camelia Sinensis leaf extract. Hematol Rep. 2013;5:21-25
  8. Squier C, Brogden K. Human oral mucosa. Chichester, West Sussex, U.K.: Wiley-Blackwell; 2011
  9. White S, Pharoah M. Oral radiology: principles and interpretation, 7th ed. St. Louis: Elsevier; 2014
  10. Al-Ansari S, Zecha JAEM, Barasch A, de Lange J, Rozema FR, Raber- Durlacher JE. Oral mu-cositis induced by anticancer therapies. Curr Oral Health Rep (2015) 2:202-11. doi:10.1007/s40496-015-0069-4
  11. Picardi A, Miranda M, Liciani F, Paterno G, Arcese W, Bollero P. Identification of oral risk fac-tors for chronic graft versus host disease in haematological patients who underwent allogeneic haematopoietic stem cell transplantation. Oral Implantol (Rome). 2017 Jan 21;10(4):390-397. doi:10.11138/orl/2017.10.4.390. eCollection 2017 Oct-Dec. PubMed PMID: 29682256;PubMed Cen-tral PMCID: PMC5892662.
  12. Lalla RV, Sonis ST, Peterson DE. Management of oral mucositis in patients who have cancer. Dent Clin North Am (2008) 52(1):61-77,viii. doi:10.1016/j. cden.2007.10.002
  13. Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, et al. MASCC/ ISOO clinical prac-tice guidelines for the management of mucositis secondary to cancer therapy. Cancer (2014) 120(10):1453-61. doi:10.1002/cncr.2859 14 Lalla RV. The MASCC/ISOO mucositis guidelines update: introduction to the first set of articles. Support Care Cancer (2013) 21(1):301-2. doi:10.1007/ s00520-012-1660-z
  14. Lalla RV, Ashbury FD. The MASCC/ISOO mucositis guidelines: dissemination and clinical im-pact. Support Care Cancer (2013) 21(11):3161-3. doi:10.1007/s00520-013-1924-2 16) Bollero P., Franco R., Gianfreda F., Gualtieri P., Miranda M., Barlattani A. Epidemiology, Eti-opathogenesis, Treatment and Prognosis of Oral Thermal Burns from Food and Drinks. Dental Hy-potheses 2019. 10. 80. 10.4103/denthyp.denthyp_56_19.
  15. Avci P, Gupta A, Sadasivam M, et al. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg 2013;32(1):41-52 18) Bollero, P., Rocco, F., Gianfreda, F., Miranda, M., Ottria, L., \& Barlattani, A. (2019). The influ-ence of pemphigus vulgaris on oral health. ORAL \& IMPLANTOLOGY, 12(2), 174-179.
  16. Lin P, Sermersheim M, Li H, et al. Zinc in wound healing modulation. Nutrients 2017;10(1):E16. DOI: 10.3390/nu10010016 20) Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089 21) Picardi A, Ferraro AS, Miranda M, Meconi F, Lanti A, Adorno G, Arcese W, Bollero P. Therapeu-tic efficiency of platelet gel for the treatment of oral ulcers related to chronic graft versus host disease after allogeneic haematopoietic stem cell transplantation. Oral Implantol (Rome). 2017 Jan 21;10(4):398-405. doi: 10.11138/orl/2017.10.4.398. eCollection 2017 Oct-Dec. PubMed PMID: 29682257; PubMed Central PMCID: PMC5892654 22) Cantore S, Crincoli V, Boccaccio A, Uva AE, Fiorentino M, Monno G, Bollero P, Derla C, Fabiano F, Ballini A, Santacroce L. Recent Advances in Endocrine, Metabolic and Immune Disorders: Mes-enchymal Stem Cells (MSCs) and Engineered Scaffolds. Endocr Metab Immune Disord Drug Tar-gets. 2018;18(5):466-469. doi:10.2174/1871530318666180423102905. Review. PubMed PMID: 29692270.
Being tested
TREATMENT OF ORAL MUCOSITIS USING PLATELET-RICH-FIBRIN (PRF)
Keywords
PRF, Oral Mucositis
Medical subject headings
Graft vs Host Disease, Stomatitis, Ulcer

What participants receive

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

  • TREATMENT OF ORAL MUCOSITIS USING PLATELET-RICH-FIBRIN (PRF)Device

    All patients were affected by oral mucositis (9 RIOM, 6 chemotherapy-related oral mucositis). They were treated with almost 2 different systemic therapies before and during platelets gel applications. Median of time before the lesions were treated with platelets gel were 7 days. Lesions affected buccal mucosa, tongue, labial commissure and lower lip. Preliminar parameters were the microbiological contamination of lesions and presence of pain. Patients refer spontaneous widespread pain worsened by swallowing and feeding. Response to treatment has been evaluated in relation to the reduction of lesions dimensions, to the involution of pain and presence of granulation tissue after every application of platelet gel.

What is being measured

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

  1. Complete Oral Mucositis Healing

    Healing of oral lesions

    Measured: 1 week

Timeline

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

  1. First posted24 Aug 2021
  2. Study start1 Jul 2017
  3. Primary completion1 May 2019
  4. Study completion19 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018754
Sponsor's protocol ID
25071995
Status last verified
Aug 2021
First submitted
18 Aug 2021
Last updated
24 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sroussi HY, Epstein JB, Bensadoun RJ, Saunders DP, Lalla RV, Migliorati CA, Heaivilin N, Zumsteg ZS. Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med. 2017 Dec;6(12):2918-2931. doi: 10.1002/cam4.1221. Epub 2017 Oct 25.

    PubMed 29071801
  • Bensinger W, Schubert M, Ang KK, Brizel D, Brown E, Eilers JG, Elting L, Mittal BB, Schattner MA, Spielberger R, Treister NS, Trotti AM 3rd. NCCN Task Force Report. prevention and management of mucositis in cancer care. J Natl Compr Canc Netw. 2008 Jan;6 Suppl 1:S1-21; quiz S22-4.

    PubMed 18289497
  • Agren MS, Rasmussen K, Pakkenberg B, Jorgensen B. Growth factor and proteinase profile of Vivostat(R) platelet-rich fibrin linked to tissue repair. Vox Sang. 2014 Jul;107(1):37-43. doi: 10.1111/vox.12120. Epub 2013 Dec 10.

    PubMed 24320875
  • Hirase T, Ruff E, Surani S, Ratnani I. Topical application of platelet-rich plasma for diabetic foot ulcers: A systematic review. World J Diabetes. 2018 Oct 15;9(10):172-179. doi: 10.4239/wjd.v9.i10.172.

    PubMed 30364787

Questions about this trial

What is this clinical trial studying?

An observational study of Graft Vs Host Disease and Oral Mucositis (Ulcerative), run by University of Rome Tor Vergata at 1 site in Italy.

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: finished, as of the sponsor's last update on 24 Aug 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 Italy. 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?

Complete Oral Mucositis Healing (time frame: 1 week). 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 NCT05018754, which also lists 4 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 24 Aug 2021.

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