Scalp Cooling in Gynecologic Cancer Patients

Not Applicable

Completed

• Conditions: Gynecologic Cancer; Chemotherapy-Induced Change
• Interventions: Device: Scalp cooling Paxman Orbis II system; Other: Standard treatment

• Registration Number: NCT04168242
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-11-11
• Study First Submitted: 2019-11-16
• Study First Submitted QC: 2019-11-16
• Study First Posted: 2019-11-19
• Primary Completion: 2023-01-30
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Scalp cooling Paxman Orbis II system	Patients have scalp cooling during the chemotherapy period
Control arm	Standard treatment	Patients do not have scalp cooling during the chemotherapy period

Primary Outcome Measures

Name	Time	Method
Incidence and grading of chemotherapy induced alopecia	9 months	Will be assessed by Dean's scale Grade 0 - 4 (from 0% to \>75% hair loss)

Secondary Outcome Measures

Name	Time	Method
Anxiety / depression level	9 months	Anxiety and depression scales will be assessed by GAD7 PHQ9. A higher score means the more frequent an event is.
Incidence and grading of treatment-related adverse events	9 months	Will be assessed by CTCAE v5.0
Quality-of-life scale	9 months	Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong