Chemotherapy-Induced Change, Gynecologic Cancer
Conditions
Keywords
Gynecologic cancer, chemotherapy-induced alopecia, scalp cooling
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.
Interventions
DEVICEScalp 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.
OTHERStandard treatment
The control arm will not have scalp cooling before, during and after chemotherapy.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Hong Kong
Outcome results
None listed