Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients

Samsung Medical Center

Status: Completed

Conditions: Neoplasm, Breast

Treatments: Device: Scalp cooling system 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04678544

PAXMAN

Details and patient eligibility

About

This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. Female adults who are newly diagnosed with stage 1-3 breast cancer and expected to receive Adriamycin or/Taxane will participate in the study. The study design is an open-label, randomized controlled trial. The patients will be randomly assigned to intervention or control groups. Intervention patients will have applied scalp cooling during 4 or 6 cycles of their chemotherapy. The primary endpoint is the effectiveness of the PSCS2 for reducing permanent chemotherapy-induced alopecia. Secondary endpoints include chemotherapy-induced alopecia, distress due to chemotherapy-induced alopecia, quality of life, and patient-reported alopecia-related side effects.

After the RCT, only patients who were expected to receive 4, 6, or 8 cycles of chemotherapy with an anthracycline regimen were further enrolled in the intervention group as a single-arm trial.

Full description

Adjuvant chemotherapy decreases the risk of recurrence. However, it has distressing side effects, including alopecia. Chemotherapy-induced alopecia (CIA) is a common and distressing side effect of many chemotherapy drugs. In a previous study, more than half of the breast cancer patients experienced higher distress due to CIA during cancer treatment, and this distress was strongly associated with negative body image, overall health status, and psychosocial well-being. Recently scalp cooling has been known to be one of the effective options for hair loss prevention. However, there was little information regarding the effect on the prevention of permanent CIA(PCIA). This study aims to examine the impact of scalp cooling on the prevention of PCIA as well as CIA.

Female adults who are newly diagnosed with stage 1-3 breast cancer and aged less than 70 years will be screened for a plan of undergoing Adriamycin or/and Taxane regimen as neoadjuvant or adjuvant chemotherapy. Eligible patients will be randomly assigned to intervention or control groups (2:1 ratio). Patients in the intervention group will have applied scalp cooling during 4 or 6 cycles of their chemotherapy whereas participants in the control group will be observed.

The objective of the study is to examine whether the Paxman scalp cooling system is effective in reducing PCIA in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. In addition, the impact of Paxman scalp cooling on the prevention of CIA, alopecia-related distress, quality of life, and patient-reported alopecia-related side effects will also be explored.

After the RCT, only patients who were expected to receive 4, 6, or 8 cycles of chemotherapy with an anthracycline regimen were further enrolled in the intervention group as a single-arm trial.

Enrollment: 170 patients

Sex: Female

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed breast cancer, stage I-III
• Expected to receive 4 or 6 cycles of Adriamycin or Taxance of chemotherapy regimen as neoadjuvant or adjuvant chemotherapy with curative intent (e.g., AC, TC, or TCHP)
• For the additional single arm, patients who expected to receive 4, 6, or 8 cycles of Adriamycin or Taxance chemotherapy regimen as neoadjuvant or adjuvant chemotherapy with curative intent (e.g., AC, TC, TCHP, or AC+T).

Exclusion criteria

• Any other concurrent malignancy including hematological malignancies
• Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
• Serum Albumin < 3.0
• Subjects who are underweight (defined as a BMI < 17.5)
• Subjects who have had previous chemotherapy exposure
• Subjects with cold agglutinin disease or cold urticarial
• Subject who had thyroid disease, diabetes or cardiac disease
• Subject who had auto-immune disease
• History of treatment due to alopecia
• Subject who had scalp disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Before the chemotherapy, patients in intervention group will use cooling cap 30 minutes before chemotherapy. Once chemotherapy drug be ready, patients will receive chemotherapy. After the chemotherapy, patients go to the cooling cap area (room) and wear the cooling cap additional 20 minute for Taxane and 90 minute for other drugs, respectively.

Treatment:

Device: Scalp cooling system 2

Controlled Group

No Intervention group

Description:

chemotherapy with usual care