Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT04168242
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE November 16, 2019
First Posted Date  ICMJE November 19, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2019)
Anxiety / depression level [ Time Frame: 9 months ]
Anxiety and depression scales will be assessed by questionnaires.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2019)
  • 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.
  • Incidence and grading of chemotherapy induced alopecia [ Time Frame: 9 months ]
    Will be assessed by CTCAE v5.0 and Dean's scale
  • Incidence and grading of treatment-related adverse events [ Time Frame: 9 months ]
    Will be assessed by CTCAE v5.0
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2019)
  • Quality-of-life scale [ Time Frame: 9 months ]
    Different functional scales will be assessed by validated questionnaires.
  • Incidence and grading of chemotherapy induced alopecia [ Time Frame: 9 months ]
    Will be assessed by CTCAE v5.0 and Dean's scale
  • Incidence and grading of treatment-related adverse events [ Time Frame: 9 months ]
    Will be assessed by CTCAE v5.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Scalp Cooling in Gynecologic Cancer Patients
Official Title  ICMJE The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Gynecologic Cancer
  • Chemotherapy-Induced Change
Intervention  ICMJE
  • 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.
  • Other: Standard treatment
    The control arm will not have scalp cooling before, during and after chemotherapy.
Study Arms  ICMJE
  • Experimental: Experimental arm
    Patients have scalp cooling during the chemotherapy period
    Intervention: Device: Scalp cooling Paxman Orbis II system
  • Placebo Comparator: Control arm
    Patients do not have scalp cooling during the chemotherapy period
    Intervention: Other: Standard treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lesley Lau 852-22554265 lsk382@hku.hk
Contact: Tina Wei 852-22554265 tinawei@hku.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04168242
Other Study ID Numbers  ICMJE UWB 19-514
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ka Yu Tse The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP