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Article ; Online: Analysis of T-cell alloantigen response

Iwahara, Naoya / Hotta, Kiyohiko / Iwami, Daiki / Tanabe, Tatsu / Tanaka, Yuka / Ito, Yoichi M / Otsuka, Takuya / Murai, Sachiyo / Takada, Yusuke / Higuchi, Haruka / Sasaki, Hajime / Hirose, Takayuki / Harada, Hiroshi / Shinohara, Nobuo

Frontiers in immunology

2023 Volume 14, Page(s) 1164794

Abstract: ... on T-cell alloantigen response ...

Abstract	Donor-specific antibodies (DSAs) are the main cause of graft loss over time. The direct pathway of alloantigen recognition is important in the pathogenesis of acute rejection. Recent studies have suggested that the direct pathway also contributes to the pathogenesis of chronic injury. Nevertheless, there are no reports on T-cell alloantigen response
MeSH term(s)	Humans ; Kidney Transplantation/adverse effects ; Isoantigens ; Antibodies
Chemical Substances	Isoantigens ; Antibodies
Language	English
Publishing date	2023-05-03
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2023.1164794
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Article ; Online: Failure of Costimulatory Blockade-induced Regulatory T Cells to Sustain Long-term Survival of High Ischemic Allografts.

Kohei, Naoki / Tanaka, Toshiaki / Miyairi, Satoshi / Tsuda, Hidetoshi / Abe, Toyofumi / Su, Charles A / Kish, Danielle D / Tanabe, Kazunari / Valujskikh, Anna / Min, Booki / Fairchild, Robert L

Transplantation

2023 Volume 107, Issue 9, Page(s) 1935–1944

Abstract: ... ischemia-reperfusion injury, which amplifies infiltrating endogenous memory CD8 T-cell activation within hours after ... resistant rejection. This study tested strategies inhibiting memory CD8 T-cell activation within such high ... blockade. At 60 d posttransplant, regulatory T cells (Treg) were depleted in recipients of high ischemic ...

Abstract	Background: Costimulatory blockade-induced allograft tolerance has been achieved in rodent models, but these strategies do not translate well to nonhuman primate and clinical transplants. One confounder that may underlie this discrepancy is the greater ischemic inflammation imposed on the transplants. In mice, cardiac allografts subjected to prolonged cold ischemic storage (CIS) before transplant have increased ischemia-reperfusion injury, which amplifies infiltrating endogenous memory CD8 T-cell activation within hours after transplantation to mediate acute graft inflammation and cytotoxic lymphocyte-associated molecule-4 immunoglobulin-resistant rejection. This study tested strategies inhibiting memory CD8 T-cell activation within such high ischemic allografts to achieve long-term survival. Methods: A/J (H-2 a ) hearts subjected to 0.5 or 8 h of CIS were transplanted to C57BL/6 (H-2 b ) recipients and treatment with peritransplant costimulatory blockade. At 60 d posttransplant, regulatory T cells (Treg) were depleted in recipients of high ischemic allografts with anti-CD25 monoclonal antibody (mAb) or diphtheria toxin. Results: Whereas peritransplant (days 0 and +1) anti-lymphocyte function-associated antigen-1 mAb and anti-CD154 mAb prolonged survival of >60% allografts subjected to minimal CIS for >100 d, only 20% of allografts subjected to prolonged CIS survived beyond day 80 posttransplant and rejection was accompanied by high titers of donor-specific antibody. Peritransplant anti-lymphocyte function-associated antigen-1, anti-tumor necrosis factor-α, and anti-CD154 mAb plus additional anti-CD154 mAb on days 14 and 16 obviated this donor-specific antibody and promoted Treg-mediated tolerance and survival of 60% of high ischemic allografts beyond day 100 posttransplant, but all allografts failed by day 120. Conclusions: These studies indicate a strategy inducing prolonged high ischemic allograft survival through Treg-mediated tolerance that is not sustained indefinitely.
MeSH term(s)	Mice ; Animals ; T-Lymphocytes, Regulatory ; Heart Transplantation/adverse effects ; Mice, Inbred C57BL ; Transplantation, Homologous ; CD40 Ligand ; Allografts ; Graft Survival ; Graft Rejection/prevention & control
Chemical Substances	CD40 Ligand (147205-72-9)
Language	English
Publishing date	2023-08-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	208424-7
ISSN	1534-6080 ; 0041-1337
ISSN (online)	1534-6080
ISSN	0041-1337
DOI	10.1097/TP.0000000000004570
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Zs.A 488: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Granzyme K- and amphiregulin-expressing cytotoxic T cells and activated extrafollicular B cells are potential drivers of IgG4-related disease.

Koga, Risako / Maehara, Takashi / Aoyagi, Ryuichi / Munemura, Ryusuke / Murakami, Yuka / Doi, Atsushi / Kono, Michihito / Yamamoto, Hidetaka / Niiro, Hiroaki / Kiyoshima, Tamotsu / Tanabe, Mika / Nakano, Toshiaki / Matsukuma, Yuta / Kawano, Mitsuhiro / Stone, John H / Pillai, Shiv / Nakamura, Seiji / Kawano, Shintaro

The Journal of allergy and clinical immunology

2023 Volume 153, Issue 4, Page(s) 1095–1112

Abstract: ... Objective: We sought to perform single-cell RNA sequencing and T-cell receptor and B-cell receptor ... sequencing to obtain a comprehensive, unbiased view of tissue-infiltrating T and B cells.: Methods ... We performed unbiased single-cell RNA-sequencing analysis for the transcriptome and T-cell receptor sequencing ...

Abstract	Background: IgG4-related disease (IgG4-RD), an example of a type I immune disease, is an immune-mediated fibrotic disorder characterized by dysregulated resolution of severe inflammation and wound healing. However, truly dominant or pathognomonic autoantibodies related to IgG4-RD are not identified. Objective: We sought to perform single-cell RNA sequencing and T-cell receptor and B-cell receptor sequencing to obtain a comprehensive, unbiased view of tissue-infiltrating T and B cells. Methods: We performed unbiased single-cell RNA-sequencing analysis for the transcriptome and T-cell receptor sequencing and B-cell receptor sequencing on sorted CD3 Results: Almost all clonally expanded T cells in these lesions were either Granzyme K (GZMK)-expressing CD4 Conclusions: The above-mentioned cells likely participate in T-B collaborative events, suggesting possible avenues for targeted therapies. Our findings were validated using orthogonal approaches, including multicolor immunofluorescence and the use of comparator disease groups, to support the central role of cytotoxic CD4
MeSH term(s)	Humans ; Amphiregulin/genetics ; CD8-Positive T-Lymphocytes ; Granzymes ; Immune System Diseases ; Immunoglobulin G4-Related Disease ; Receptors, Antigen, B-Cell ; Receptors, Antigen, T-Cell ; T-Lymphocytes, Cytotoxic ; Transforming Growth Factor beta
Chemical Substances	Amphiregulin ; Granzymes (EC 3.4.21.-) ; Receptors, Antigen, B-Cell ; Receptors, Antigen, T-Cell ; Transforming Growth Factor beta ; GZMK protein, human (EC 3.4.21.-) ; AREG protein, human
Language	English
Publishing date	2023-12-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2023.11.916
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Article ; Online: Thrombophlebitis Migrans As the Prodrome of Adult T-Cell Leukemia-Lymphoma.

Matsuda-Hirose, Haruna / Nashimoto, Yuko / Tanabe, Aki / Ogata, Masao / Iwao, Masao / Mizukami, Kazuhiro / Nishida, Haruto / Hatano, Yutaka

Annals of dermatology

2022 Volume 34, Issue 4, Page(s) 312–314

Language	English
Publishing date	2022-08-07
Publishing country	Korea (South)
Document type	Journal Article
ZDB-ID	1012662-4
ISSN	2005-3894 ; 1013-9087
ISSN (online)	2005-3894
ISSN	1013-9087
DOI	10.5021/ad.20.184
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Article: Health-Related Quality of Life Evaluation Using the Short Form-36 in Patients With Human T-Lymphotropic Virus Type 1-Associated Myelopathy.

Frontiers in medicine

2022 Volume 9, Page(s) 879379

Abstract: Background: Human T-lymphotropic virus type 1 (HTLV-1)-associated myelopathy (HAM) is ...

Abstract	Background: Human T-lymphotropic virus type 1 (HTLV-1)-associated myelopathy (HAM) is a neuroinflammatory disease, causing various neurological symptoms, including motor, sensory, and bladder and bowel dysfunctions. This study was designed to reveal the impact of HAM and related symptoms on health-related quality of life (HRQoL). Methods: We analyzed the Short Form-36 (SF-36) and clinical data of 538 patients with HAM registered in the HAM-net, a nationwide patient registry for HAM in Japan. HRQoL was evaluated using the SF-6D (a health state utility value calculated from the SF-36) and eight SF-36 subscales. A general liner model was used to estimate the impact of major HAM-related symptoms, including gait dysfunction, sensory disturbance in the legs (pain and numbness), urinary dysfunction, and constipation, on the SF-6D and SF-36 subscale scores. Results: The mean age and disease duration were 62.0 and 16.5 years, respectively. Of the patients, 73.2% needed walking aid; 42.7 and 67.1% had leg pain and numbness, respectively; 92.1% had urinary dysfunction; and 77.9% had constipation. The mean SF-6D score was 0.565, which was significantly lower than the national average (0.674 in the 60-69 years age group; Conclusion: HRQoL of patients with HAM was worse than that of the general population and was associated with all major symptoms. Thus, patients should be comprehensively managed to achieve better HRQoL.
Language	English
Publishing date	2022-04-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2022.879379
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Article ; Online: Impact of activated invariant natural killer T cells on the expansion of regulatory T cell precursors in murine thymocytes in vitro.

Katsumata, Haruki / Ikemiyagi, Masako / Hirai, Toshihito / Kanzawa, Taichi / Ishii, Rumi / Miyairi, Satoshi / Fukuda, Hironori / Saiga, Kan / Okumi, Masayoshi / Ishii, Yasuyuki / Yokoo, Takashi / Tanabe, Kazunari

Immunology letters

2018 Volume 206, Page(s) 41–48

Abstract: ... that the establishment of mixed chimerism by treatment with a ligand for invariant natural killer T (iNKT) cells ...

Abstract	Tolerance induction is a goal of clinical transplantation to prevent graft rejection without the lifelong use of immunosuppressive drugs. In a series of mouse studies, we previously reported that the establishment of mixed chimerism by treatment with a ligand for invariant natural killer T (iNKT) cells with CD40 signal blockade makes it possible to prevent allograft rejection without immunosuppressants, and this approach fails in thymectomized recipient mice. In this study, we showed that iNKT cells in murine thymocyte cultures are indispensable for the expansion of CD4
MeSH term(s)	Animals ; Biomarkers ; Cell Communication ; Cells, Cultured ; Cytokines/biosynthesis ; Immunophenotyping ; Lymphocyte Activation/genetics ; Lymphocyte Activation/immunology ; Mice ; Mice, Knockout ; Natural Killer T-Cells/immunology ; Natural Killer T-Cells/metabolism ; T-Lymphocytes, Regulatory/immunology ; T-Lymphocytes, Regulatory/metabolism ; Thymocytes/immunology ; Thymocytes/metabolism
Chemical Substances	Biomarkers ; Cytokines
Language	English
Publishing date	2018-11-29
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	445150-8
ISSN	1879-0542 ; 0165-2478
ISSN (online)	1879-0542
ISSN	0165-2478
DOI	10.1016/j.imlet.2018.11.013
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Zs.A 1512: Show issues

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Article ; Online: Microbiota-derived butyrate limits the autoimmune response by promoting the differentiation of follicular regulatory T cells.

Takahashi, Daisuke / Hoshina, Naomi / Kabumoto, Yuma / Maeda, Yuichi / Suzuki, Akari / Tanabe, Hiyori / Isobe, Junya / Yamada, Takahiro / Muroi, Kisara / Yanagisawa, Yuto / Nakamura, Atsuo / Fujimura, Yumiko / Saeki, Aiko / Ueda, Mizuki / Matsumoto, Ryohtaroh / Asaoka, Hanako / Clarke, Julie M / Harada, Yohsuke / Umemoto, Eiji /

Komatsu, Noriko / Okada, Takaharu / Takayanagi, Hiroshi / Takeda, Kiyoshi / Tomura, Michio / Hase, Koji

EBioMedicine

2020 Volume 58, Page(s) 102913

Abstract: ... although the pathological relevance has remained obscure. Follicular regulatory T (T: Methods: We examined ... reaction prior to the onset of the CIA. Butyrate mitigated these pathological events by promoting T ... Interpretation: Accordingly, microbiota-derived butyrate serves as an environmental cue to enhance T: Funding ...

Abstract	Background: Rheumatoid arthritis (RA) is a chronic debilitating autoimmune disorder with a high prevalence, especially in industrialized countries. Dysbiosis of the intestinal microbiota has been observed in RA patients. For instance, new-onset untreated RA (NORA) is associated with the underrepresentation of the Clostridium cluster XIVa, including Lachnospiraceae, which are major butyrate producers, although the pathological relevance has remained obscure. Follicular regulatory T (T Methods: We examined the contribution of microbe-derived butyrate in controlling autoimmune arthritis using collagen-induced arthritis (CIA) and SKG arthritis models. We phenotyped autoimmune responses in the gut-associated lymphoid tissues (GALT) in the colon and joint-draining lymph nodes in the CIA model. We developed an in vitro CXCR5 Findings: Microbe-derived butyrate suppressed the development of autoimmune arthritis. The immunization of type II collagen (CII) caused hypertrophy of the GALT in the colon by amplifying the GC reaction prior to the onset of the CIA. Butyrate mitigated these pathological events by promoting T Interpretation: Accordingly, microbiota-derived butyrate serves as an environmental cue to enhance T Funding: This work was supported by AMED-Crest (16gm1010004h0101, 17gm1010004h0102, 18gm1010004h0103, and 19gm1010004s0104 to KH), the Japan Society for the Promotion of Science (JP17KT0055, JP16H01369, and JP18H04680 to KH; JP17K15734 to DT), Keio University Special Grant-in-Aid for Innovative Collaborative Research Projects (KH), Keio Gijuku Fukuzawa Memorial Fund for the Advancement of Education and Research (DT), the SECOM Science and Technology Foundation (KH), the Cell Science Research Foundation (KH), the Mochida Memorial Foundation for Medical and Pharmaceutical Research (DT), the Suzuken Memorial Foundation (KH and DT), the Takeda Science Foundation (KH and DT), The Science Research Promotion Fund, and The Promotion and Mutual Aid Corporation for Private Schools of Japan (KH).
MeSH term(s)	Acetylation ; Adoptive Transfer ; Aged ; Arthritis, Experimental/chemically induced ; Arthritis, Experimental/immunology ; Arthritis, Experimental/therapy ; Arthritis, Rheumatoid/chemically induced ; Arthritis, Rheumatoid/immunology ; Arthritis, Rheumatoid/therapy ; Autoimmunity ; Bacteria/metabolism ; Butyrates/pharmacology ; Cell Differentiation/drug effects ; Cells, Cultured ; Gastrointestinal Microbiome ; Histone Deacetylase Inhibitors/pharmacology ; Histone Deacetylases/metabolism ; Histones/metabolism ; Humans ; Lymphoid Tissue/cytology ; Lymphoid Tissue/drug effects ; Lymphoid Tissue/immunology ; Middle Aged ; T-Lymphocytes, Regulatory/cytology ; T-Lymphocytes, Regulatory/drug effects ; T-Lymphocytes, Regulatory/transplantation
Chemical Substances	Butyrates ; Histone Deacetylase Inhibitors ; Histones ; Histone Deacetylases (EC 3.5.1.98)
Language	English
Publishing date	2020-07-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2851331-9
ISSN	2352-3964
ISSN (online)	2352-3964
DOI	10.1016/j.ebiom.2020.102913
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Zs.A 7090: Show issues

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Article ; Online: Clinical course of neurogenic bladder dysfunction in human T-cell leukemia virus type-1-associated myelopathy/tropical spastic paraparesis: a nationwide registry study in Japan.

Iijima, Naoki / Yamauchi, Junji / Yagishita, Naoko / Araya, Natsumi / Aratani, Satoko / Tanabe, Kenichiro / Sato, Tomoo / Takata, Ayako / Yamano, Yoshihisa

Orphanet journal of rare diseases

2021 Volume 16, Issue 1, Page(s) 355

Abstract: Background: Most patients with human T-cell leukemia virus type 1-associated myelopathy ...

Abstract	Background: Most patients with human T-cell leukemia virus type 1-associated myelopathy/tropical spastic paraparesis (HAM/TSP) develop neurogenic bladder dysfunction. However, longitudinal changes and treatment effects remain poorly understood. This study aimed to characterize the clinical course of urinary dysfunction in this population. Methods: This prospective observational study included 547 patients enrolled in HAM-net, a nationwide registry for HAM/TSP in Japan. Urinary dysfunction severity was evaluated using the HAM/TSP-bladder dysfunction symptom score (HAM-BDSS) and the HAM/TSP-bladder dysfunction severity grade (HAM-BDSG). These specific measures were recently developed for assessing urinary dysfunction in HAM/TSP. We analyzed longitudinal changes over a 6-year follow-up period, associations between urinary and gait dysfunction, and treatment efficacy of urinary catheterization and mirabegron (a β3-adrenergic agonist for overactive bladder symptoms). Results: The mean (standard deviation [SD]) age and disease duration at enrollment were 61.9 (10.7) years and 16.6 (11.6) years, respectively, and 74.6% of patients were women. Only 8.0% were free from urinary symptoms (HAM-BDSG 0), 65.4% had urinary symptoms or were on medication (HAM-BDSG I), and 23.2% and 3.3% used intermittent and indwelling catheters (HAM-BDSG II and III), respectively. HAM-BDSG and BDSS were worse in patients with greater gait dysfunction (p < 0.001 for both). During the 6-year follow-up, 66.7% of patients with HAM-BDSG 0 developed new urinary symptoms. Of those with HAM-BDSG I at enrollment, 10.8% started using urinary catheters. Importantly, HAM-BDSS significantly improved after initiating catheterization (mean [SD] change, - 8.93 [10.78], p < 0.001). The number of patients receiving mirabegron increased in the fourth year. Multivariable linear regression analysis significantly associated mirabegron with improvement in HAM-BDSS (- 5.82, 95% confidence interval - 9.13 to - 2.51, p = 0.001). Conclusions: Urinary dysfunction affected 92% of patients and progressed over the 6-year follow-up. Urinary symptoms were more severe in patients with poorer gait function. Urinary catheterization and mirabegron were effective in relieving symptoms. Effective utilization of real-world data is key to establishing evidence for rare diseases, such as HAM/TSP.
MeSH term(s)	Female ; Humans ; Japan/epidemiology ; Leukemia, T-Cell ; Paraparesis, Tropical Spastic ; Registries ; Urinary Bladder, Neurogenic/etiology
Language	English
Publishing date	2021-08-09
Publishing country	England
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ISSN	1750-1172
ISSN (online)	1750-1172
DOI	10.1186/s13023-021-01990-3
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Article ; Online: Significance of revised criteria for chronic active T cell-mediated rejection in the 2017 Banff classification: Surveillance by 1-year protocol biopsies for kidney transplantation.

Nakagawa, Kaneyasu / Tsuchimoto, Akihiro / Ueki, Kenji / Matsukuma, Yuta / Okabe, Yasuhiro / Masutani, Kosuke / Unagami, Kohei / Kakuta, Yoichi / Okumi, Masayoshi / Nakamura, Masafumi / Nakano, Toshiaki / Tanabe, Kazunari / Kitazono, Takanari

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

2020 Volume 21, Issue 1, Page(s) 174–185

Abstract: Diagnostic criteria for chronic active T cell-mediated rejection (CA-TCMR) were revised ...

Abstract	Diagnostic criteria for chronic active T cell-mediated rejection (CA-TCMR) were revised in the Banff 2017 consensus, but it is unknown whether the new criteria predict graft prognosis of kidney transplantation. We enrolled 406 kidney allograft recipients who underwent a 1-year protocol biopsy (PB) and investigated the diagnostic significance of Banff 2017. Interobserver reproducibility of the 3 diagnosticians showed a substantial agreement rate of 0.68 in Fleiss's kappa coefficient. Thirty-three patients (8%) were classified as CA-TCMR according to Banff 2017, and 6 were previously diagnosed as normal, 12 as acute TCMR, 10 with borderline changes, and 5 as CA-TCMR according to Banff 2015 criteria. Determinant factors of CA-TCMR were cyclosporine use (vs tacrolimus), previous acute rejection, and BK polyomavirus-associated nephropathy. In survival analysis, the new diagnosis of CA-TCMR predicted a composite graft endpoint defined as doubling serum creatinine or death-censored graft loss (log-rank test, P < .001). In multivariate analysis, CA-TCMR was associated with the second highest risk of the composite endpoint (hazard ratio: 5.42; 95% confidence interval, 2.02-14.61; P < .001 vs normal) behind antibody-mediated rejection. In conclusion, diagnosis of CA-TCMR in Banff 2017 may facilitate detecting an unfavorable prognosis of kidney allograft recipients who undergo a 1-year PB.
MeSH term(s)	Biopsy ; Graft Rejection/diagnosis ; Graft Rejection/etiology ; Graft Survival ; Humans ; Kidney ; Kidney Transplantation/adverse effects ; Reproducibility of Results ; T-Lymphocytes
Language	English
Publishing date	2020-07-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	2060594-8
ISSN	1600-6143 ; 1600-6135
ISSN (online)	1600-6143
ISSN	1600-6135
DOI	10.1111/ajt.16093
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Zs.A 5542: Show issues

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Article ; Online: Study protocol of a single-arm phase 2 study evaluating the preventive effect of topical hydrocortisone for capecitabine-induced hand-foot syndrome in colorectal cancer patients receiving adjuvant chemotherapy with capecitabine plus oxaliplatin (T-CRACC study).

Iimura, Yohei / Furukawa, Naoki / Ishibashi, Masaaki / Ahiko, Yuka / Tanabe, Taro / Aikou, Susumu / Shida, Dai / Nojima, Masanori / Kuroda, Seiichiro / Boku, Narikazu

BMC gastroenterology

2022 Volume 22, Issue 1, Page(s) 341

Abstract: Backgrounds: Clinical evidence of the preventive effectiveness of medium-class topical corticosteroids for capecitabine-induced hand foot syndrome (HFS) is limited. Although the pathogenesis and mechanism of HFS are unclear, inflammatory reactions are ... ...

Abstract	Backgrounds: Clinical evidence of the preventive effectiveness of medium-class topical corticosteroids for capecitabine-induced hand foot syndrome (HFS) is limited. Although the pathogenesis and mechanism of HFS are unclear, inflammatory reactions are thought to be involved in HFS development. This study aimed to evaluate the preventive effect of medium-class topical corticosteroids (hydrocortisone butyrate 0.1% topical therapy) for capecitabine-induced HFS in patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine plus oxaliplatin. Methods: This is a single-center, single-arm, phase 2 study. Patients with colorectal cancer scheduled to receive adjuvant chemotherapy with capecitabine plus oxaliplatin are enrolled, and topical hydrocortisone butyrate 0.1% is applied prophylactically in addition to standard moisturizing therapy. The primary endpoint is the incidence of grade ≥ 2 HFS within three months. The secondary endpoints are the time to onset of HFS, rates of dose reduction, schedule delay, discontinuation caused by capecitabine-induced HFS, and other adverse events. All adverse events are evaluated by clinical pharmacists and attending physicians. Discussion: This study is expected to contribute to the establishment of new supportive care for preventing HFS, not only for colorectal cancer patients receiving adjuvant chemotherapy, but also for various cancer patients receiving capecitabine-based chemotherapy. Trial registration: This trial was registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs031220002. Registered 5 April 2022, https://jrct.niph.go.jp/search Protocol version V.1.0, 16 February 2022.
MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Capecitabine/adverse effects ; Chemotherapy, Adjuvant/adverse effects ; Clinical Trials, Phase II as Topic ; Colorectal Neoplasms/etiology ; Fluorouracil/adverse effects ; Hand-Foot Syndrome/drug therapy ; Hand-Foot Syndrome/etiology ; Hand-Foot Syndrome/prevention & control ; Humans ; Hydrocortisone/therapeutic use ; Oxaliplatin/adverse effects
Chemical Substances	Oxaliplatin (04ZR38536J) ; Capecitabine (6804DJ8Z9U) ; Fluorouracil (U3P01618RT) ; Hydrocortisone (WI4X0X7BPJ)
Language	English
Publishing date	2022-07-14
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2041351-8
ISSN	1471-230X ; 1471-230X
ISSN (online)	1471-230X
ISSN	1471-230X
DOI	10.1186/s12876-022-02411-w
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