Trial reportBone marrow transplantation2019
Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial.
Trial report in Bone marrow transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03704597 (Cryotherapy as Prophylaxis Against Oral Mucositis After High-dose Melphalan and Autologous Stem Cell Transplantation for Myeloma), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cryotherapy as Prophylaxis Against Oral Mucositis After High-dose Melphalan and Autologous Stem Cell Transplantation for Myeloma: a Randomised, Open-label, Phase 3, Non-inferiority Trial Comparing Two and Seven Hours of Cryotherapy.
Who cites it
17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Oral cryotherapy for management of chemotherapy-induced oral mucositis in haematopoietic cell transplantation: a systematic review.BMC cancer · 2022Pooled it
- Efficacy of Oral Cryotherapy in the Prevention of Oral Mucositis Associated with Cancer Chemotherapy: Systematic Review with Meta-Analysis and Trial Sequential Analysis.Current oncology (Toronto, Ont.) · 2021Pooled it
- Nutritional problems and their non-pharmacological treatment in adults undergoing haematopoietic stem cell transplantation-A systematic review.European journal of cancer care · 2020Pooled it
- Systematic review of oral cryotherapy for the management of oral mucositis in cancer patients and clinical practice guidelines.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Pooled it
- Trial
- Tolerability and safety of a new oral device for prevention and treatment of oral mucositis in patients with hematologic malignancies undergoing chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Trial
- Cryopreventive temperatures prior to chemotherapy.Medical oncology (Northwood, London, England) · 2023Trial
- Effect of cryotherapy in preventing mucositis associated with the use of 5-fluorouracil.Revista latino-americana de enfermagem · 2020Trial
- Efficacy of Polyvinylpyrrolidone-Zinc Gluconate and Taurine Gel in the Prophylaxis of Oral Mucositis in Adults Undergoing High-Dose Chemotherapy and Allogeneic Stem Cell Transplantation.Diseases (Basel, Switzerland) · 2025Article
- Recent advances in oral cryotherapy for the management of anticancer therapy-induced oral mucositis.Future science OA · 2025Review
- Impact of cryotherapy on incidence and severity of oral mucositis in hematopoietic stem cell transplantation: retrospective observational study.Scientific reports · 2025Observational
- Determinants of Severe Oral Mucositis Development Despite Photobiomodulation Therapy in Stem Cell Transplant Patients.Dentistry journal · 2025Article
- Treated well but feeling poorly: examining supportive care devices in oncology practice.The oncologist · 2025Article
- Oral Care in Head and Neck Radiotherapy: Proposal for an Oral Hygiene Protocol.Journal of personalized medicine · 2024Review
- Optimizing high dose melphalan.Blood reviews · 2024Review
- Oral health, dental treatment, and medication related osteonecrosis of the jaw in multiple myeloma - a longitudinal cohort study.BMC oral health · 2024Article
- Clinical trials: design, endpoints and interpretation of outcomes.Bone marrow transplantation · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as standard prophylaxis against oral mucositis, the long duration of the treatment affects compliance owing to side effects. In this prospective, randomised trial, 94 patients (62 males/32 females; median age 59 years, range 34-69) with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 h (N = 46) or 2 h (N = 48). Oral mucositis was evaluated prospectively. No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively; 95% CI -0.09 to 0.049; p = 0.98) as between the groups. Two hours of cryotherapy was as effective as 7 h in terms of protecting against severe oral mucositis in connection with autologous HSCT for myeloma. This trial is registered with ClinicalTrials.gov (NCT03704597).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.