Scalp Cooling in Gynecologic Cancer Patients

NCT04168242 | Completed

• 1 other identifier: UWB 19-514
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Chemotherapy-Induced Change

Keywords

Gynecologic cancer; chemotherapy-induced alopecia; scalp cooling

Outcome Measures

Primary Outcomes (1)

• Incidence and grading of chemotherapy induced alopecia

  Will be assessed by Dean's scale Grade 0 - 4 (from 0% to \>75% hair loss)

  9 months

Secondary Outcomes (3)

• Quality-of-life scale

  9 months

• Anxiety / depression level

  9 months

• Incidence and grading of treatment-related adverse events

  9 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patients have scalp cooling during the chemotherapy period

Device: Scalp cooling Paxman Orbis II system

Control arm

PLACEBO COMPARATOR

Patients do not have scalp cooling during the chemotherapy period

Other: Standard treatment

Interventions

Scalp cooling Paxman Orbis II system DEVICE

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.

Experimental arm

Standard treatment OTHER

The control arm will not have scalp cooling before, during and after chemotherapy.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

• Ka Yu Tse

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2019
• First Posted: November 19, 2019
• Study Start: November 11, 2019
• Primary Completion: January 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-10

Locations

HK (1)