Scalp Cooling in Gynecologic Cancer Patients

Gynecologic Cancer Clinical Trial

Official title:

The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168242
• Other study ID #: UWB 19-514
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-Induced Change
• Gynecologic Cancer

Intervention

Device:
• Scalp cooling Paxman Orbis II system
The experimental arm will have scalp cooling that starts 30 minutes before the chemotherapy, continues throughout the infusion of the chemotherapy, and lasts for 20-90 minutes more depending on the type of regimen.

Other:
• Standard treatment
The control arm will not have scalp cooling before, during and after chemotherapy.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and grading of chemotherapy induced alopecia	Will be assessed by Dean's scale Grade 0 - 4 (from 0% to >75% hair loss)	9 months
Secondary	Quality-of-life scale	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.	9 months
Secondary	Anxiety / depression level	Anxiety and depression scales will be assessed by GAD7 PHQ9. A higher score means the more frequent an event is.	9 months
Secondary	Incidence and grading of treatment-related adverse events	Will be assessed by CTCAE v5.0	9 months