Gynecologic CancerNCT04168242
Scalp Cooling in Gynecologic Cancer Patients
A study testing Scalp cooling Paxman Orbis II system and Standard treatment in people with Gynecologic Cancer and Chemotherapy-Induced Change, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Chemotherapy-Induced Change
- What is being tested?
- Scalp cooling Paxman Orbis II system and Standard treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Nov 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be at least 18 years old.
- Patients with primary gynecologic cancers.
- 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.
- Patients who are fit to give informed consent.
Who cannot join
- Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded.
- Patients who have the following conditions will be excluded:
- migraine
- scalp or brain metastasis
- hypothyroidism
- uncontrolled diabetes
Show all 13Show fewer
- liver and / or renal derangement (where liver enzymes and / or creatinine are 1.5x more than upper normal limit)
- severe untreated anaemia
- cold sensitivity
- cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
- Patients who had brain irradiation.
- Patients who have documented psychiatric disorders will be excluded.
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial
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.
Read the 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.
- Conditions
- Gynecologic Cancer, Chemotherapy-Induced Change
- Being tested
- Scalp cooling Paxman Orbis II system, Standard treatment
- Keywords
- Gynecologic cancer, chemotherapy-induced alopecia, scalp cooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp cooling Paxman Orbis II systemDevice
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 treatmentOther
The control arm will not have scalp cooling before, during and after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients have scalp cooling during the chemotherapy period Receives: Device: Scalp cooling Paxman Orbis II system |
| Control arm | Placebo comparator | Patients do not have scalp cooling during the chemotherapy period Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and grading of chemotherapy induced alopecia
Will be assessed by Dean's scale Grade 0 - 4 (from 0% to >75% hair loss)
Measured: 9 months
Secondary outcomes (3)
Quality-of-life scale
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.
Measured: 9 months
Anxiety / depression level
Anxiety and depression scales will be assessed by GAD7 PHQ9. A higher score means the more frequent an event is.
Measured: 9 months
Incidence and grading of treatment-related adverse events
Will be assessed by CTCAE v5.0
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start11 Nov 2019
- Primary completion30 Jan 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ka Yu Tse, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168242
- Sponsor's protocol ID
- UWB 19-514
- Status last verified
- Oct 2023
- First submitted
- 16 Nov 2019
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwok ST, Lau LSK, Chan TO, Chu MMY, Ngu SF, Chan KKL, Ngan HYS, Ho PPY, Wu L, Hung DSM, Lo HKY, Wong CSM, Tse KY. The efficacy of scalp cooling in patients receiving chemotherapy for primary gynecologic cancers: a randomized controlled trial. Sci Rep. 2026 Mar 18;16(1):14109. doi: 10.1038/s41598-026-44772-2.
PubMed 41851427
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial
- ClinicalTrials.gov ID
- NCT04168242
- Acronym / sponsor ID
- UWB 19-514
- Conditions
- Gynecologic Cancer, Chemotherapy-Induced Change
- Keywords
- Gynecologic cancer, chemotherapy-induced alopecia, scalp cooling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: Scalp cooling Paxman Orbis II systemPatients have scalp cooling during the chemotherapy period |
| Control arm | Placebo comparator | Other: Standard treatmentPatients do not have scalp cooling during the chemotherapy period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be at least 18 years old.
- Patients with primary gynecologic cancers.
- 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.
- Patients who are fit to give informed consent.
Key exclusion criteria (13 listed)
- Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded.
- Patients who have the following conditions will be excluded:
- Patients who had brain irradiation.
- Patients who have documented psychiatric disorders will be excluded.
- Patients who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp cooling Paxman Orbis II systemThe 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. | Device | Experimental arm |
| Standard treatmentThe control arm will not have scalp cooling before, during and after chemotherapy. | Other | Control arm |
Primary outcome
Incidence and grading of chemotherapy induced alopecia
Time frame: 9 months
Will be assessed by Dean's scale Grade 0 - 4 (from 0% to >75% hair loss)
3 secondary outcomes
Quality-of-life scale
Time frame: 9 months
Anxiety / depression level
Time frame: 9 months
Incidence and grading of treatment-related adverse events
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 41851427Kwok ST, Lau LSK, Chan TO, Chu MMY, Ngu SF, Chan KKL, Ngan HYS, Ho PPY, Wu L, Hung DSM, Lo HKY, Wong CSM, Tse KY. The efficacy of scalp cooling in patients receiving chemotherapy for primary gynecologic cancers: a randomized controlled trial. Sci Rep. 2026 Mar 18;16(1):14109. doi: 10.1038/s41598-026-44772-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Yu Tse principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp cooling Paxman Orbis II system and Standard treatment in people with Gynecologic Cancer and Chemotherapy-Induced Change, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and grading of chemotherapy induced alopecia (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04168242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.