Study on the efficacy and satisfaction of scalp cooling system "DigniCap Delta" for chemotherapy-induced Alopecia in breast cancer patients

JRCT ID: jRCTs032230065

Registered date:02/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chemotherapy Induced Alopecia
• Date of first enrollment: 02/05/2023
• Target sample size: 21
• Study type: Interventional
• Intervention(s): Scalp cooling device "DigniCap Delta" will be used to the patients at each chemotherapy treatment for a scalp cooling treatment. The scalp will be continuously cooled before, during, and after the chemotherapy treatment.

Outcome(s)

• Primary Outcome: CIA of 4 weeks after the completion of chemotherapy

Secondary Outcome

1. Evaluation of hair re-growth (Collected at 12, 24 and 48 weeks after completion of chemotherapy)
2. Patient satisfaction using a survey (Collected at the 1st, 3rd, 5th, and 8th cycles of chemotherapy, 4 weeks, 12 weeks, 24 weeks, and 48 weeks after completion of chemotherapy)
3. CTCAE Alopecia Grade (Collected at the 3rd, 5th, and 8th cycles of chemotherapy)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Female

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Tsugawa Koichiro
• Source(s) of Monetary Support: Konica Minolta, INC.