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Trial record 1 of 1 for:    NCT04168242
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Scalp Cooling in Gynecologic Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04168242
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : November 26, 2019
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Chemotherapy-Induced Change Device: Scalp cooling Paxman Orbis II system Other: Standard treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : May 30, 2022

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.

Primary Outcome Measures :
  1. Anxiety / depression level [ Time Frame: 9 months ]
    Anxiety and depression scales will be assessed by GAD7 PHQ9. A higher score means the more frequent an event is.

Secondary Outcome Measures :
  1. Quality-of-life scale [ Time Frame: 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.

  2. Incidence and grading of chemotherapy induced alopecia [ Time Frame: 9 months ]
    Will be assessed by CTCAE v5.0 and Dean's scale

  3. Incidence and grading of treatment-related adverse events [ Time Frame: 9 months ]
    Will be assessed by CTCAE v5.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04168242

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Contact: Lesley Lau 852-22554265
Contact: Tina Wei 852-22554265

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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Tina Wei    852-22554265   
Contact: Lesley Lau    852-22554265   
Sponsors and Collaborators
The University of Hong Kong
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Principal Investigator: Ka Yu Tse The University of Hong Kong
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Responsible Party: The University of Hong Kong Identifier: NCT04168242    
Other Study ID Numbers: UWB 19-514
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
Gynecologic cancer
chemotherapy-induced alopecia
scalp cooling