Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients
Condition: Neoplasm, Breast
MeSH terms: Breast Neoplasms; Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced
      alopecia in woman 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/and Taxane will participate in the study. The study design is a 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. 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 effect.
    

Detailed 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 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 prevention of permanent CIA(PCIA). This study aims to examine the impact of scalp cooling
      on 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 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 intervention group will have applied scalp cooling
      during 4 or 6 cycles of their chemotherapy whereas participants in control group will be
      observed.

      The objective of the study is to examine whether Paxman scalp cooling system is effective in
      reducing PCIA in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. In
      addition, impact of Paxman scalp cooling on prevention of CIA, alopecia-related distress,
      quality of life and patient-reported alopecia related side effect will be also explored.
    

Intervention name(s): Scalp cooling system 2
Intervention type(s): Device
Intervention description(s): The investigational device which will be used in this study is the Paxman Scalp Cooling System 2. This device is manufactured by: Paxman Coolers Limited. This is a free-standing, electrically-powered, mobile refrigeration unit which circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap which is attached to, and covers, the top of the patient's head. The Paxman Scalp Cooling System is intended to be used for scalp cooling of patients who are receiving chemotherapy for the treatment of solid tumors, in order to reduce the risk of chemotherapy-induced alopecia.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial, Single center
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Scalp cooling system; Randomized controlled trial; Permanent-Chemotherapy-Induced Alopecia; Chemotherapy-Induced Alopecia