Breast Cancer Trial, Recruiting NCT05484973 Sponsor: Cooler Heads Care Inc. Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT05484973
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women aged 21 years or older
  • People with a documented diagnosis of breast cancer at stage I, II, or III
  • People who have a planned chemotherapy treatment that includes a taxane (a specific type of chemotherapy drug), given either before or after surgery, with the goal of curing the cancer
  • People whose chemotherapy plan may also include other medicines such as trastuzumab, pertuzumab, cyclophosphamide, or carboplatin
  • People whose current chemotherapy treatment is expected to be completed within six months
  • People who had chemotherapy causing hair loss at least two years ago and whose hair has fully grown back since then
  • People with a general health and activity level rated at 80% or above on the Karnofsky scale, which means able to carry out normal activity with only minor symptoms (confirm with trial site)
  • People who are willing and able to sign a consent form for this study
  • People who are willing and able to complete all required study activities

Who may not be able to join:

  • People with a pattern of hair thinning or baldness at a level of I-3 or higher on the Savin scale, which is a standard tool doctors use to measure hair loss (confirm with trial site)
  • People with an autoimmune condition that affects hair, such as alopecia areata or lupus with associated hair loss
  • People who have previously had radiation treatment to the whole brain
  • People whose planned chemotherapy does not include paclitaxel or docetaxel, or whose plan includes a type of drug called an anthracycline (for example, regimens known as AC/T, EC/T, or TAC)
  • People receiving hormone therapy at the same time as chemotherapy (hormone therapy taken after chemotherapy is permitted)
  • People who are currently using or have previously used hair growth products such as Nutrafol, minoxidil, or Keranique
  • People with a serious ongoing infection or medical illness that could affect their ability to complete the treatment and follow-up
  • People with a history of lasting, moderate or severe hair loss caused by a previous chemotherapy treatment
  • People with a history of, or current exposure to, other treatments, drugs, devices, or procedures known to cause hair loss
  • People with sensitivity to cold temperatures
  • People with another serious or life-threatening cancer occurring at the same time
  • People with untreated or poorly controlled overactive or underactive thyroid conditions
  • People with a history of or current diagnosis of cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia, which are conditions affecting how the blood behaves in cold temperatures
  • People with a blood cancer occurring at the same time
  • People currently participating in another clinical trial or receiving another experimental treatment
  • People whom the trial doctor does not consider to be a suitable candidate for the study, for any reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Kate Dilligan, Cooler Heads Inc.

Phone: 9715067552

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Cooler Heads Care Inc.
Registry
ClinicalTrials.gov
Start date
8 November 2024
Est. completion
31 March 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Hair Loss

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov