Study on the efficacy and satisfaction of scalp cooling system DigniCap Delta for chemotherapy-induced Alopecia in breast cancer patients
- Conditions
- Chemotherapy Induced Alopecia
- Registration Number
- JPRN-jRCTs032230065
- Lead Sponsor
- Tsugawa Koichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 21
(1) Histologically diagnosed as breast cancer
(2) Confirmed to receive neo adjuvant or adjuvant chemotherapy for primary breast cancer
(3) 18 to 70 years old
(4) PS 0-1
(5) No history of use of chemotherapy which may cause hair loss
(6) Stage I-III female breast cancer patients
(7) Combination of 4 cycles of anthracyclines and 4 cycles of taxanes (excluding single doses of each, limited to the treatment order of anthracycline to taxane). Concurrent use of anti-HER2 drugs to HER2-positive patients are permitted.
List of applicable regimens:
EC (3 weeks * 4 times) followed by DTX (3 weeks * 4 times)
dose-dense EC (2 weeks * 4 times) followed by DTX (3 weeks * 4 times)
dose-dense EC (2 weeks * 4 times) followed by dose-dense PTX (2 weeks * 4 times)
(8) No history of treatment for alopecia (use of hair restorers, wigs, hair transplantation, etc. within 6 months), including the history of any alopecia caused other than chemotherapy (alopecia areata, etc.)
(9) Patients who can understand the content of the clinical research and have the ability to sign the consent by their decision
(10) Patients who have signed the informed consent to participate in this study
(1) Patients with conditions of contraindications for DigniCap Delta
1. Cold sensitivity
2. Cold agglutinin disease (including past history)
3. Cryoglobulinemia (including past history)
4. Cryofibrinogenemia (including past history)
5. Cold urticaria (including past)
6. Central nervous system malignant tumor (primary or metastatic)
7. Squamous cell carcinoma of the lung
8. Small cell carcinoma of the lung
9. Cancers of the head and neck
10. Skin cancers including melanoma, squamous cell carcinoma, and Merkel cell carcinoma
11. Hematologic malignancies treated with curative intent with chemotherapy
12. Solid tumor malignancies with a high likelihood of metastases in transit
13. Patients scheduled for myeloablative chemotherapy
14. Patients who are scheduled to undergo skull irradiation
15. Patients who have previously received skull irradiation
(2) Patients who are judged to be unsuitable by the doctor's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method