RightFit
RecruitingPhase 2

Scalp Cooling in MBC

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The research study procedures include: screening for eligibility, photographs, hair loss assessments, questionnaires and study treatment including evaluations and follow up visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares hair loss in people who use the Paxman Scalp Cooling System with those who do not. It is for adults with breast cancer that has spread to other parts of the body who will receive sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.

This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The name of the study intervention involved in this study is: * Paxman Scalp Cooling System

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men and women age 18 or older.
  • Have breast cancer that has spread to other parts of the body.
  • Can care for yourself and are up and about at least half of your waking hours (ECOG activity score of 2 or less).
  • Have hair at the start of the study.
  • Plan to receive at least 4 treatment cycles of full-dose sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.
  • If you choose scalp cooling, start it with your first treatment dose.

Who can't join

  • Have a blood cancer, such as leukemia or lymphoma.
  • Have cancer that has spread to the scalp.
  • Have any hair loss before treatment starts.
  • Have cold agglutinin disease (a blood condition triggered by cold) or cold urticaria (hives caused by cold).
  • Are scheduled for chemotherapy that destroys bone marrow.
  • Have a history of migraines, cluster headaches, or tension headaches diagnosed by a doctor or treated with prescribed medicine. If migraines were caused by a past health problem that is now resolved, the study leader may allow you to join.
  • Have lichen planus (a condition that causes swelling and irritation of skin or moist body linings) or lupus (a disease in which the body's defenses attack healthy tissue).
  • Are receiving any other cancer drugs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2 * Participant is ≥ 18 years old. * Hair present at baseline. * One of the following full dose chemotherapy regimens must be planned for at least 4 cycles: * Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle * Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks * Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle * The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group. Exclusion Criteria: * Known hematological malignancies (i.e. leukemia or lymphoma) * Known scalp metastases. * Baseline alopecia (defined CTCAE 5.0 grade \> 0, see Appendix B) * Subjects with cold agglutinin disease or cold urticaria. * Subjects who are scheduled for bone marrow ablation chemotherapy. * Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, the subject may go on study at the discretion of the Principal Investigator. * Subjects who have lichen planus or lupus. * Participants who are receiving any additional anti-cancer agents

Study sites (2)

MA