UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール（ビタミンB6）予防投与の有効性に関する臨床評価

英語
Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer

一般向け試験名略称/Acronym

日本語
進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール予防投与の有効性に関する臨床評価

英語
Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer

科学的試験名/Scientific Title

日本語
進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール（ビタミンB6）予防投与の有効性に関する臨床評価

英語
Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer

科学的試験名略称/Scientific Title:Acronym

日本語
進行・再発乳癌を対象としたカペシタビン治療による手足症候群に対するピリドキサール予防投与の有効性に関する臨床評価

英語
Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
進行・再発乳癌

英語
Locally advanced or metastatic breast cancer

疾患区分1/Classification by specialty

血液・腫瘍内科学/Hematology and clinical oncology

疾患区分2/Classification by malignancy

悪性腫瘍/Malignancy

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
進行・再発乳癌患者に対し、カペシタビン単独又はカペシタビン併用化学療法を行い、カペシタビン初回治療例における手足症候群（HFS）に対するピリドキサール（ビタミンB6）投与の予防効果を検討する。

英語
This randomized phase II trial evaluates pridoxine for preventing of hand-foot syndrome (HFS) compared with no pyridoxine in breast cancer patients treated with capacitabine.

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

実務的/Pragmatic

試験のフェーズ/Developmental phase

第Ⅱ相/Phase II

主要アウトカム評価項目/Primary outcomes

日本語
Grade2以上のHFS発現までの期間

英語
Time to the onset of HFS (Grade2 or 3)

副次アウトカム評価項目/Key secondary outcomes

日本語
・HFSの発現割合（全Grade、Grade別）
・HFS発現までの期間（全Grade、Grade別）
・併用療法別HFSの発現状況
・カペシタビンの投与状況（投与量、投与期間、総投与量と総投与期間）
・安全性
・QOL（Skindex29）
・指圧計による指圧の変動

英語
Incidence of HFS (any Grade)
Time to the onset of HFS (any Grade)
Incidence of HFS by chemotherapy type
Treatment duration and dosage of Capecitabine administration
Safety
Quality of life by Skindex29
Finger pressure by pinch meter

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

オープン/Open -no one is blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

はい/YES

動的割付/Dynamic allocation

はい/YES

試験実施施設の考慮/Institution consideration

動的割付けの際に施設を調整因子としている/Institution is considered as adjustment factor in dynamic allocation.

ブロック化/Blocking

いいえ/NO

割付コードを知る方法/Concealment

中央登録/Central registration

群数/No. of arms

2

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

医薬品/Medicine

介入1/Interventions/Control_1

日本語
ピリドキサール（ビタミンB6）非予防投与群：カペシタビン単独療法、カペシタビン＋パクリタキセル併用療法、カペシタビン＋シクロホスファミド併用療法のいずれかを行う

英語
No prodpxine group: Patients receiving capecitabine mono therapy or capecitabine combination chemotherapy

介入2/Interventions/Control_2

日本語
ピリドキサール（ビタミンB6）予防投与群：カペシタビン単独又は併用療法にピリドキサール60mg/日の予防投与を行う

英語
Pridoxine group: Patients receiving capecitabine mono therapy or capecitabine combination chemotherapy with pyridoxal 60mg po daily

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

20

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

女/Female

選択基準/Key inclusion criteria

日本語
1、組織学的診断で乳癌であることが確認されている進行・再発の乳癌患者
2、満20歳以上の女性患者
3、The Eastern Cooperative Oncology Group(ECOG) Performance Statusが0-1
4、経口摂取可能である患者
5、登録日から3カ月以上の生存が可能と期待される患者
6、患者本人から文書により試験参加に同意が得られていること
7、登録前21日以内の主要臓器機能について以下の規準を満たしている

英語
1. Diagnosis of advanced breast cancer
2. 20 years old or more
3. ECOG performance status 0-1
4. Can eat
5. Life expectancy more than 3 months
6. Written informed consents
7. Sufficient organ functions

除外基準/Key exclusion criteria

日本語
1、フルオロウラシル製剤に対して重篤な過敏症の既往がある。またはDPD欠損が疑われるようなフルオロピリミジン系薬剤に対する副作用が発現したことのある患者
2、カペシタビンの治療歴を有する患者
3、本治療に支障をきたすおそれのある薬剤過敏症既往のある患者
4、コントロールできない重篤な合併症のある患者
5、登録までの無病期間5年未満の重複がんまたは合併を有する患者
6、妊娠または妊娠している可能性のある患者
7、その他、担当医師が不適と判断したもの

英語
1. History of serious drug hypersensitivity or a history of drug allergy by fluoropyrimidine. History of adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase deficiency
2. Capecitabine used prior chemotherapy
3. History of drug hypersensitivity not suitable for this study
4. Uncontrolled serious complications
5. Multiple primary cancer within 5 years
6. Pregnant women or possibly pregnant women
7. Other conditions not suitable for this study

目標参加者数/Target sample size

150

責任研究者/Name of lead principal investigator

日本語

名	竜也
ミドルネーム
姓	遠山

英語

名	Tatsuya
ミドルネーム
姓	Toyama

所属組織/Organization

日本語
名古屋市立大学大学院 医学研究科

英語
Nagoya City University Hospital

所属部署/Division name

日本語
乳腺外科学分野

英語
Breast Surgery

郵便番号/Zip code

467-8601

住所/Address

日本語
名古屋市瑞穂区瑞穂町字川澄１番地

英語
1, Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan

電話/TEL

052-851-5511

Email/Email

toyamat-ncu@umin.ac.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	慶子
ミドルネーム
姓	大森

英語

名	Keiko
ミドルネーム
姓	Ohmori

組織名/Organization

日本語
東海乳癌臨床試験グループ（TBCRG）

英語
Tokai Breast Cancer Clinical Research Group (TBCRG)

部署名/Division name

日本語
事務局

英語
Office

郵便番号/Zip code

464-8681

住所/Address

日本語
名古屋市千種区鹿子殿1-1

英語
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan

電話/TEL

052-762-6111

試験のホームページURL/Homepage URL

Email/Email

hiwata@aichi-cc.jp

機関名/Institute

日本語
その他

英語
Tokai Breast Cancer Clinical Research Group (TBCRG)

機関名/Institute
（機関選択不可の場合）

日本語
東海乳癌臨床試験グループ（TBCRG）

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Comprehensive Support Project for Oncological Research (CSPOR)

機関名/Organization
（機関選択不可の場合）

日本語
財団法人パブリックリサーチセンター乳癌臨床研究支援事業（CSPOR）

組織名/Division

日本語

組織の区分/Category of Funding Organization

財団/Non profit foundation

研究費拠出国/Nationality of Funding Organization

日本語
日本

英語
Japan

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
名古屋市立大学病院

英語
Nagoya City University Hospital

住所/Address

日本語
名古屋市瑞穂区瑞穂町字川澄１番地

英語
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

電話/Tel

0528515511

Email/Email

toyamat-ncu@umin.ac.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2010

年

01

月

01

日

プロトコル掲載URL/URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/29948956

試験結果の公開状況/Publication of results

最終結果が公表されている/Published

結果掲載URL/URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29948956

組み入れ参加者数/Number of participants that the trial has enrolled

135

主な結果/Results

日本語
A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively.

英語
A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively.

主な結果入力日/Results date posted

2019

年

06

月

30

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語
From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.

英語
From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.

参加者の流れ/Participant flow

日本語
From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.

英語
From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.

有害事象/Adverse events

日本語
Leukopenia has not previously been reported
as an adverse event related to pyridoxine therapy. In this study, the median number of treatment cycles of capecitabine-containing chemotherapy was 5.5 and 4.0 in the pyridoxine and no pyridoxine groups, respectively. Therefore, the increased incidence of leukopenia in the pyridoxine group may be attributable to a longer exposure to chemotherapy.

英語
Leukopenia has not previously been reported
as an adverse event related to pyridoxine therapy. In this study, the median number of treatment cycles of capecitabine-containing chemotherapy was 5.5 and 4.0 in the pyridoxine and no pyridoxine groups, respectively. Therefore, the increased incidence of leukopenia in the pyridoxine group may be attributable to a longer exposure to chemotherapy.

評価項目/Outcome measures

日本語
A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no
pyridoxine groups, respectively.

英語
A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no
pyridoxine groups, respectively.

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2009

年

11

月

09

日

倫理委員会による承認日/Date of IRB

2009

年

10

月

01

日

登録・組入れ開始（予定）日/Anticipated trial start date

2010

年

01

月

01

日

フォロー終了(予定)日/Last follow-up date

2012

年

06

月

01

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2009

年

12

月

22

日

最終更新日/Last modified on

2019

年

06

月

30

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000003567

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003567