UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000036472 |
| Receipt No. | R000041384 |
| Scientific Title | A Multicenter controlled trial of PAX-15 Hair Loss Prevention System with chemotherapy-induced alopecia in breast cancer patients in Japan |
| Date of disclosure of the study information | 2019/04/11 |
| Last modified on | 2019/04/11 (Ver. 1) |
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| Basic information | ||
| Public title | A Multicenter controlled trial of PAX-15 Hair Loss Prevention System with chemotherapy-induced alopecia in breast cancer patients in Japan | |
| Acronym | HOPE study | |
| Scientific Title | A Multicenter controlled trial of PAX-15 Hair Loss Prevention System with chemotherapy-induced alopecia in breast cancer patients in Japan | |
| Scientific Title:Acronym | HOPE study | |
| Region |
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| Condition | ||
| Condition | Female patients with stage I/II primary breast cancer who were scheduled to undergo adjuvant/neoadjuvant chemotherapy | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To assess the efficacy and safety of scalp cooling devices to prevent chemotherapy-induced alopecia in Japanese breast cancer patients |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Proportion of patients with no alopecia after the 4th cycle of chemotherapy treatment |
| Key secondary outcomes | |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -but assessor(s) are blinded |
| Control | No treatment |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Prevention | |
| Type of intervention |
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| Interventions/Control_1 | Scalp cooling by scalp cooling device is done 30 minutes pre-chemotherapy, duration of chemotherapy and more than 90 minutes post-chemotherapy. | |
| Interventions/Control_2 | No cooling | |
| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
| Interventions/Control_5 | ||
| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Female | |||
| Key inclusion criteria | 1. New diagnosis of breast cancer stage 1-2
2. Female with Age >= 20 and age <= 70 3. Planning to undergo 4 cycles of adjuvant/neoadjuvant chemotherapy by following regimens: - AC (Adriamycin 60 mg/m2 with cyclophosphamide 600 mg/m2) - EC (Epirubicin 100 mg/m2 with cyclophosphamide 600 mg/m2) - TC (Docetaxel 75 mg/m2 with cyclophosphamide 600 mg/m2) - FEC (Epirubicin100 mg/m2 with 5-Fluroruacil 500 mg/m2 and cyclophosphamide 500 mg/m2) A dose dense schedule is not allowed. 4. Written informed consent |
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| Key exclusion criteria | 1. Stage 3 or higher breast cancer
2. Any other concurrent malignancy including hematological malignancies 3. Baseline alopecia (defined CTCAE v4.0 grade >= 1) 4. Subjects with cold agglutinin disease or cold urticaria 5. Subjects who are scheduled for bone marrow ablation chemotherapy 6. Personal history of migraines, cluster or tension headaches 7. Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal 8. Serum Albumin < 3.0 g/dL 9. Subjects with anemia (defined as a hemoglobin < 10 g/dL) 10. Abnormal TSH, AND: If high, abnormal free T4 defined as out of normal limits If low, abnormal free T4 or T3 defined as out of normal limits 11. Subjects who have diabetes with a Hgb A1c > 7% 12. Subjects who have lichen planus or lupus 13. Subjects who are underweight (defined as a BMI < 17.5) 14. Subjects who have had previous chemotherapy exposure 15.Subjects with difficulty of the proper cap fitting 16. Subjects with head injury or burn 17. Participation in any clinical trials at present or up to 30 days before consent acquisition. 18.Subjects with difficulty of complying with treatment regimen determined in the protocol 19.Life expectancy of subjects is expected less than 1 year. 20.Subjects determined to be ineligible by an investigator. |
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| Target sample size | 61 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | National Cancer Center Hospital | ||||||
| Division name | Department of Breast Surgery | ||||||
| Zip code | 104-0045 | ||||||
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan | ||||||
| TEL | 03-3542-2511 | ||||||
| takinosh@ncc.go.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| Organization | Century Medical,Inc. | ||||||
| Division name | Clinical Affairs Group | ||||||
| Zip code | 141-8588 | ||||||
| Address | 1-11-2 Osaki, Shinagawa-ku, Tokyo 141-8588, Japan | ||||||
| TEL | 03-3491-1552 | ||||||
| Homepage URL | |||||||
| megumi_okamoto@cmi.co.jp | |||||||
| Sponsor | |
| Institute | Century Medical,Inc. |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Century Medical,Inc. |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | National Cancer Center Institutional Review Board |
| Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan |
| Tel | 03-3542-2511 |
| chiken_CT@ml.res.ncc.go.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | Unpublished due to the article in submission |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | Unpublished due to the article in submission | ||||||
| Number of participants that the trial has enrolled | 58 | ||||||
| Results | Unpublished due to the article in submission |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Unpublished due to the article in submission |
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| Participant flow | Unpublished due to the article in submission |
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| Adverse events | Unpublished due to the article in submission |
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| Outcome measures | Unpublished due to the article in submission |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
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| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041384 |
