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Completed

NCT Number: NCT04168242

Scalp Cooling in Gynecologic Cancer Patients

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.

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Key information

Conditions

Gynecologic Cancer Chemotherapy-Induced Change

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

standard treatment

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  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. 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.

  3. Incidence and grading of treatment-related adverse events

    Time frame: 9 months

    Will be assessed by CTCAE v5.0

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2019
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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