CompletedNot Applicable

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

South Korea170 participantsStarted 2020-12-23

Plain-language summary

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.

Who can participate

Age range20 Years – 69 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Permanent chemotherapy-induced alopecia

Timeframe: 6 months (±2 months) after completion of chemotherapy and intervention

Trial details

NCT IDNCT04678544

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-27