Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)

Tao OUYANG

Status and phase: Unknown; Phase 3

Conditions: Primary Breast Cancer

Treatments: Device: Scalp cooling system; Device: Cold cap

Study type: Interventional

Funder types: Other

Identifiers

NCT03711877

BCP-25

Details and patient eligibility

About

This is a phase III, single-center, prospective, open-label, randomized,controlled study

Full description

To conduct a prospective randomized controlled study comparing the effect of scalp cooling system (DigniCap) and chemical cold cap on preventing chemotherapy-induced alopecia in a group of breast cancer patients receiving standard anthracycline followed paclitaxel regimens. To obtain the exact data on the role of different methods of preventing alopecia in Chinese women with breast cancer.

PASS 11 software was used to calculate the sample size. According to the results of previous studies, the hair retention rate of the cold cap group was 67.7%, the hair retention rate of the scalp cooling system group was 50.5%, α=0.05，Power=0.8. The sample size was calculated to be at least 128 cases in each group, 256 cases in total.

Enrollment: 256 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients, 18≦age ≦66 years
• Invasive breast cancer diagnosed with core needle needle biopsy
• Staging I-II
• Without chemotherapy contraindications, and planned to receive neoadjuvant chemotherapy with a standard regimen (containing 4-cycle dose-dense anthracycline followed 4-cycle paclitaxel)
• Attend the study voluntarily, sign the informed consent

Exclusion criteria

• History of malignant tumors
• With chemotherapy contraindications
• With severe dermatosis and severe sparsity
• History of chronic diseases such as cerebrovascular disease, migraine and hyperthyroidism
• Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
• Refuse to join the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

scalp cooling system

Experimental group

Description:

'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.

Treatment:

Device: Scalp cooling system

cold cap

Active Comparator group

Description:

'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.

Treatment:

Device: Cold cap