Scalp Cooling in Gynecologic Cancer Patients

Study Overview
=================
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.

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

Conditions
-----------------
Gynecologic Cancer, Chemotherapy-Induced Change

Intervention / Treatment
-----------------
* Device: Scalp cooling Paxman Orbis II system
* Other: Standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be at least 18 years old. Patients with primary gynecologic cancers. 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. Patients who are fit to give informed consent. Exclusion Criteria: Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded. Patients who have the following conditions will be excluded: migraine scalp or brain metastasis hypothyroidism uncontrolled diabetes liver and / or renal derangement (where liver enzymes and / or creatinine are 1.5x more than upper normal limit) severe untreated anaemia cold sensitivity cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia Patients who had brain irradiation. Patients who have documented psychiatric disorders will be excluded. Patients who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Patients have scalp cooling during the chemotherapy period | Device: Scalp cooling Paxman Orbis II system<br>* 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.<br>|
| Placebo Comparator: Control arm<br>Patients do not have scalp cooling during the chemotherapy period | Other: Standard treatment<br>* The control arm will not have scalp cooling before, during and after chemotherapy.<br>|

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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| Incidence and grading of treatment-related adverse events | Will be assessed by CTCAE v5.0 | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gynecologic cancer, chemotherapy-induced alopecia, scalp cooling