Scalp Cooling in Gynecologic Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Chemotherapy-Induced Change
• Intervention / Treatment: Device: Scalp cooling Paxman Orbis II system; Other: Standard treatment

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; Patients have scalp cooling during the chemotherapy period	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.
Placebo Comparator: Control arm; Patients do not have scalp cooling during the chemotherapy period	Other: Standard treatment; The control arm will not have scalp cooling before, during and after chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Incidence and grading of treatment-related adverse events	Will be assessed by CTCAE v5.0	9 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Ka Yu Tse, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: November 16, 2019
• First Submitted That Met QC Criteria: November 16, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Gynecologic cancer; chemotherapy-induced alopecia; scalp cooling
• Other Study ID Numbers: UWB 19-514

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No