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
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Cancer Chemotherapy-Induced Change||Device: Scalp cooling Paxman Orbis II system Other: Standard treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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|
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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT04168242
|Contact: Lesley Laufirstname.lastname@example.org|
|Contact: Tina Weiemail@example.com|
|Principal Investigator:||Ka Yu Tse||The University of Hong Kong|