Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2019-11-11
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental arm
Patients have scalp cooling during the chemotherapy period
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.
Control arm
Patients do not have scalp cooling during the chemotherapy period
Standard treatment
The control arm will not have scalp cooling before, during and after chemotherapy.
Interventions
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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.
Standard treatment
The control arm will not have scalp cooling before, during and after chemotherapy.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Principal Investigators
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Ka Yu Tse
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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UWB 19-514
Identifier Type: -
Identifier Source: org_study_id