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

NCT03711877 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2021-11-29

No results posted yet for this study

Summary

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

Conditions

  • Primary Breast Cancer

Interventions

DEVICE

Scalp cooling system

Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward. Temperature of scalp cooling system can be controlled constantly, the effect of reducing scalp temperature maybe better and patient tolerance maybe better. Meanwhile, there is a higher likelihood of hair retention due to a tight fit in scalp cooling system.

DEVICE

Cold cap

The operation of chemical cold cap is convenient and the price was low, and the economic burden of patients was not increased. But it is necessary to replace the cold cap periodically during chemotherapy, and the temperature during chemotherapy is difficult to keep constant.

Sponsors & Collaborators

  • Tao OUYANG

    lead OTHER

Principal Investigators

  • Xinying Yu, Master · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03711877 on ClinicalTrials.gov