Clinical trial · Interventional
PROSpECT-PRIOR-2-CHEMO: PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications
PROSpECT-PRIOR-2-CHEMO: A Feasibility RCT of Novel Dental Intervention PRIOR[Proactive Intensive Oral Review & Treatment] in Patients Scheduled for Chemotherapy for Myeloma-ASCT & Hematological Cancers to Mitigate Chemotherapy Complications
NCT06450821CI-TRIAL-00077839not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Oncology | — | UNRESOLVED | — |
| Oral Mucositis | — | UNRESOLVED | — |
| Periodontitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRIOR [Proactive Intensive Oral Review & Treatment] | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Control Arm: NHS standard care pathway delivered.
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Intervention Arm: Professional Oral Health Care (POHC) referred to as PRIOR \[Proactive Intensive Oral Review \& Treatment\] prior to chemotherapy.
- interventionNames
- Procedure: PRIOR [Proactive Intensive Oral Review & Treatment]
Primary outcomes (1)
- measure
- Number of participants able to attend treatment sessions required for completion of treatment plan, within the defined chemotherapy therapeutic window.
- timeFrame
- 100 days from the date of commencement of chemotherapy (about 4 months from randomisation)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (mod-high/risk trial participants): * 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 Exclusion Criteria: * 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
References
Publications (12)
- BACKGROUNDRaber-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
- BACKGROUNDBrennan 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
- BACKGROUNDJia 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
- BACKGROUNDZecha 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
- BACKGROUNDLaine 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
- BACKGROUNDBorowski 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
- 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.