Scalp Cooling in Gynecologic Cancer Patients

The University of Hong Kong (HKU)

Status: Completed

Conditions: Chemotherapy-Induced Change; Gynecologic Cancer

Treatments: Device: Scalp cooling Paxman Orbis II system; Other: Standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04168242

UWB 19-514

Details and patient eligibility

About

In gynecologic cancers, many common chemotherapy agents can lead to chemotherapy-induced alopecia. Currently scalp cooling is the most well studied preventive measure. However, its acceptability and its impact on patients' QOL in Asian population is unclear.

Full description

Dynamic scalp cooling system prevents alopecia by inducing vasoconstriction leading to a reduction of scalp blood flow, thus reducing the delivery of cytotoxic drugs to the hair follicles and reducing follicular metabolic activities. One recent meta-analysis included 10 studies showed that the efficacy was 43% in general.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be at least 18 years old.
2. Patients with primary gynecologic cancers.
3. Patients who are going to receive at least four cycles of chemotherapy that are known to induce alopecia, such as carboplatin, paclitaxel, taxotere, topotecan, etoposide, vincristine and ifosfamide.
4. Patients who are fit to give informed consent.

Exclusion criteria

1. Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded.

2. Patients who have the following conditions will be excluded:

   1. migraine
   2. scalp or brain metastasis
   3. hypothyroidism
   4. uncontrolled diabetes
   5. liver and / or renal derangement (where liver enzymes and / or creatinine are 1.5x more than upper normal limit)
   6. severe untreated anaemia
   7. cold sensitivity
   8. cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia

3. Patients who had brain irradiation.

4. Patients who have documented psychiatric disorders will be excluded.

5. Patients who are pregnant.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Experimental arm

Experimental group

Description:

Patients have scalp cooling during the chemotherapy period

Treatment:

Device: Scalp cooling Paxman Orbis II system

Control arm

Placebo Comparator group

Description:

Patients do not have scalp cooling during the chemotherapy period

Treatment:

Other: Standard treatment