PROSpECT-PRIOR-2-CHEMO: PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications

NCT06450821 | Not Yet Recruiting

• 1 other identifier: 296640
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this feasibility trial is to determine if it is safe and feasible to treat oral health diseases in people with haematological cancers before they start their chemotherapy to reduce complications and disruption to planned chemotherapy dose or schedule.

Conditions

Oncology; Periodontitis; Myeloma; Oral Mucositis; Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• Number of participants able to attend treatment sessions required for completion of treatment plan, within the defined chemotherapy therapeutic window.

  Ability to deliver individualised planned PRIOR intervention within the defined chemotherapy therapeutic window (no less than 7 days before the start of ASCT/allo-SCT) - Number of patients able to attend sessions required by treatment plan

  100 days from the date of commencement of chemotherapy (about 4 months from randomisation)

Secondary Outcomes (13)

• Ability to recruit, recruitment rate and acceptability of randomisation

  Prior to commencement of CT and 100 days after CT

• Patient compliance with dental referral and treatment plan

  Prior to commencement of CT and 100 days after CT

• Ability to collect samples (baseline and febrile events) for trial biobank future oral biology testing/mechanistic evaluation

  Prior to commencement of CT and 100 days after CT

• Data collection via electronic health records

  Prior to commencement of CT and 100 days after CT

• Number of participants developing sepsis/bloodstream infection/febrile events

  100 days after CT

Study Arms (2)

Control Arm

NO INTERVENTION

Control Arm: NHS standard care pathway delivered.

Intervention Arm

EXPERIMENTAL

Intervention Arm: Professional Oral Health Care (POHC) referred to as PRIOR \[Proactive Intensive Oral Review \& Treatment\] prior to chemotherapy.

Procedure: PRIOR [Proactive Intensive Oral Review & Treatment]

Interventions

PRIOR [Proactive Intensive Oral Review & Treatment] PROCEDURE

Intervention Arm: Professional Oral Health Care (POHC) referred to as PRIOR \[Proactive Intensive Oral Review \& Treatment\] prior to chemotherapy.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 18years) with scheduled Chemotherapy. Specifically, patients who meet the following diagnosis and treatment window requirements:
• Myeloma- Autologous Stem Cell Transplantation (ASCT) before high-dose myeloablative CT.
• Haematological cancers suitable for Allografts Stem Cell Transplant (SCT) before CT
• Moderate / High Oral Health Risk Assessment - any one of the following:
• Clinical evidence of caries (2+ teeth)
• Clinical evidence on soft and hard tissue examination of infection, sinus, swelling or tenderness
• BPE code 3-4 in any remaining sextant
• BPE code 1-2 with \>30% BOP
• The patient is fully informed, has received PIS (patient information sheet) and considered during a 'cooling-off' period, is competent to consent, and is able to comply with minimum attendance requirements

You may not qualify if:

• Have a history of head and neck radiotherapy
• Have been treated with Denusomab, Bevacizumab, Sunitinib or Aflibercept within 9 months of the MDT date.
• Insufficient teeth \[defined as \<2\]
• Are incapable of providing informed written consent
• Are unable to comply with minimum attendance requirements

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Dental Translational & Clinical Research Unit (DenTCRU)

Leeds, West Yorkshire, LS29LU, United Kingdom

Location

Related Publications (12)

• Raber-Durlacher JE, Epstein JB, Raber J, van Dissel JT, van Winkelhoff AJ, Guiot HF, van der Velden U. Periodontal infection in cancer patients treated with high-dose chemotherapy. Support Care Cancer. 2002 Sep;10(6):466-73. doi: 10.1007/s00520-002-0346-3. Epub 2002 Mar 23.

  PMID: 12353125 BACKGROUND

• Brennan MT, Elting LS, Spijkervet FK. Systematic reviews of oral complications from cancer therapies, Oral Care Study Group, MASCC/ISOO: methodology and quality of the literature. Support Care Cancer. 2010 Aug;18(8):979-84. doi: 10.1007/s00520-010-0856-3. Epub 2010 Mar 20.

  PMID: 20306090 BACKGROUND

• Jia G, Zhi A, Lai PFH, Wang G, Xia Y, Xiong Z, Zhang H, Che N, Ai L. The oral microbiota - a mechanistic role for systemic diseases. Br Dent J. 2018 Mar 23;224(6):447-455. doi: 10.1038/sj.bdj.2018.217.

  PMID: 29569607 BACKGROUND

• Zecha JAEM, Raber-Durlacher JE, Laheij AMGA, Westermann AM, Epstein JB, de Lange J, Smeele LE. The impact of the oral cavity in febrile neutropenia and infectious complications in patients treated with myelosuppressive chemotherapy. Support Care Cancer. 2019 Oct;27(10):3667-3679. doi: 10.1007/s00520-019-04925-8. Epub 2019 Jun 20.

  PMID: 31222393 BACKGROUND

• Laine PO, Lindqvist JC, Pyrhonen SO, Strand-Pettinen IM, Teerenhovi LM, Meurman JH. Oral infection as a reason for febrile episodes in lymphoma patients receiving cytostatic drugs. Eur J Cancer B Oral Oncol. 1992 Oct;28B(2):103-7. doi: 10.1016/0964-1955(92)90036-z.

  PMID: 1306727 BACKGROUND

• Borowski B, Benhamou E, Pico JL, Laplanche A, Margainaud JP, Hayat M. Prevention of oral mucositis in patients treated with high-dose chemotherapy and bone marrow transplantation: a randomised controlled trial comparing two protocols of dental care. Eur J Cancer B Oral Oncol. 1994;30B(2):93-7. doi: 10.1016/0964-1955(94)90059-0.

  PMID: 8032307 BACKGROUND

• Tsuji K, Shibuya Y, Akashi M, Furudoi S, Yakushijin K, Kawamoto S, Okamura A, Matsuoka H, Komori T. Prospective study of dental intervention for hematopoietic malignancy. J Dent Res. 2015 Feb;94(2):289-96. doi: 10.1177/0022034514561768. Epub 2014 Dec 10.

  PMID: 25503612 BACKGROUND

• Zhang X, Zhang D, Jia H, Feng Q, Wang D, Liang D, Wu X, Li J, Tang L, Li Y, Lan Z, Chen B, Li Y, Zhong H, Xie H, Jie Z, Chen W, Tang S, Xu X, Wang X, Cai X, Liu S, Xia Y, Li J, Qiao X, Al-Aama JY, Chen H, Wang L, Wu QJ, Zhang F, Zheng W, Li Y, Zhang M, Luo G, Xue W, Xiao L, Li J, Chen W, Xu X, Yin Y, Yang H, Wang J, Kristiansen K, Liu L, Li T, Huang Q, Li Y, Wang J. The oral and gut microbiomes are perturbed in rheumatoid arthritis and partly normalized after treatment. Nat Med. 2015 Aug;21(8):895-905. doi: 10.1038/nm.3914. Epub 2015 Jul 27.

  PMID: 26214836 BACKGROUND

• Momen-Heravi F, Babic A, Tworoger SS, Zhang L, Wu K, Smith-Warner SA, Ogino S, Chan AT, Meyerhardt J, Giovannucci E, Fuchs C, Cho E, Michaud DS, Stampfer MJ, Yu YH, Kim D, Zhang X. Periodontal disease, tooth loss and colorectal cancer risk: Results from the Nurses' Health Study. Int J Cancer. 2017 Feb 1;140(3):646-652. doi: 10.1002/ijc.30486. Epub 2016 Nov 23.

  PMID: 27778343 BACKGROUND

• D'Aiuto F, Gkranias N, Bhowruth D, Khan T, Orlandi M, Suvan J, Masi S, Tsakos G, Hurel S, Hingorani AD, Donos N, Deanfield JE; TASTE Group. Systemic effects of periodontitis treatment in patients with type 2 diabetes: a 12 month, single-centre, investigator-masked, randomised trial. Lancet Diabetes Endocrinol. 2018 Dec;6(12):954-965. doi: 10.1016/S2213-8587(18)30038-X. Epub 2018 Oct 24.

  PMID: 30472992 BACKGROUND

• Konig MF, Abusleme L, Reinholdt J, Palmer RJ, Teles RP, Sampson K, Rosen A, Nigrovic PA, Sokolove J, Giles JT, Moutsopoulos NM, Andrade F. Aggregatibacter actinomycetemcomitans-induced hypercitrullination links periodontal infection to autoimmunity in rheumatoid arthritis. Sci Transl Med. 2016 Dec 14;8(369):369ra176. doi: 10.1126/scitranslmed.aaj1921.

  PMID: 27974664 BACKGROUND

• Keefe DM, Schubert MM, Elting LS, Sonis ST, Epstein JB, Raber-Durlacher JE, Migliorati CA, McGuire DB, Hutchins RD, Peterson DE; Mucositis Study Section of the Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology. Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer. 2007 Mar 1;109(5):820-31. doi: 10.1002/cncr.22484.

  PMID: 17236223 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Periodontitis; Neoplasms, Plasma Cell; Stomatitis; Febrile Neutropenia

Interventions

Lead; Therapeutics

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Histologic Type; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Zaid Ali, BChD

  LTHT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sue H Pavitt, PhD

CONTACT

+44 7939 014 659; s.pavitt@leeds.ac.uk

Anna Nielsen

CONTACT

+44 7948 776456; a.l.nielsen@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The moderate and high-risk patients will then be randomised. Those randomised to the PRIOR intervention arm will be assessed in a consultant-led Restorative Dentistry department \& treatment offered to stabilise primary dental diseases (periodontal disease, caries, and odontogenic infection). The treatment plan (by a dentist) will be delivered within the therapeutic window (the PRIOR window), defined as the period between MDT decision to offer ASCT/allo-SCT up to 7 days prior to commencement of CT for ASCT/allo-SCT. Participant treatment plans are highly personalised and therefore number of visits within the therapeutic window to deliver PRIOR are not strictly defined. PRIOR will aim to stabilise the oral health of the participant and remove obvious sources of oral health infection. Participant follow-up will monitor febrile event rate and OM incidence between groups, within the participant therapeutic window, defined as day one of SCT/CT+100 days.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: June 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

GB (1)