Anatomic Stage IV Breast Cancer AJCC v8NCT05533320
Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer
A study testing Cold Cap Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by City of Hope Medical Center.
Trial summary
This clinical trial evaluates the benefits of a portable scalp cooling system (PSCS) for improving chemotherapy-induced hair loss in patients with breast cancer that has spread to other places in the body (metastatic) and are undergoing taxane-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
- What is being tested?
- Cold Cap Therapy, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2022to 14 Nov 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
- Documented informed consent of the participant
- Age: >= 18 years
- Eastern Cooperative Oncology Group (ECOG) =< 2
- Ability to read and understand English or Spanish for questionnaires
- Documented diagnosis of metastatic breast cancer with at least a 6 month life expectancy
- A planned course of taxane based chemotherapy in the metastatic setting, including paclitaxel, docetaxel or abraxane
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- At least 6 months from the last chemotherapy causing hair loss with complete recovery of hair
- Willing to be contacted for brief annual assessments for five years
- Women of childbearing potential (WOCBP): negative urine pregnancy test
- Agreement by females of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Who cannot join
- Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
- A history of whole brain radiation with persistent hair thinning or alopecia, or concurrent whole brain radiation therapy
- Exposure to other investigational agents, drugs, device or procedure that may cause hair loss
- Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
- Any cutaneous scalp metastases
- Clinically significant liver dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
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- Clinically significant renal dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
- A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
- Evidence of untreated or poorly controlled hyper or hypothyroidism
- American Society of Anesthesiologist Class >= 3
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Pregnant or breastfeeding
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
About this study
Official title: Evaluation Of Benefits of The Portable Scalp Cooling System (PSCS) in Metastatic Breast Cancer Patients on Taxane-Based Chemotherapy
This clinical trial evaluates the benefits of a portable scalp cooling system (PSCS) for improving chemotherapy-induced hair loss in patients with breast cancer that has spread to other places in the body (metastatic) and are undergoing taxane-based chemotherapy. The PSCS is a new system designed to reduce chemotherapy induced hair loss. The PSCS is designed as a portable unit, allowing patients to leave the infusion center after chemotherapy is completed and finish scalp cooling at home. PSCS may help improve chemotherapy-induced hair loss in patients with metastatic breast cancer receiving chemotherapy.
Read the detailed description
PRIMARY OBJECTIVE:
- Measure efficacy of scalp cooling for patients undergoing taxane based chemotherapy for metastatic breast cancer.
SECONDARY OBJECTIVES:
- Assess safety of PSCS in treating patients with metastatic breast cancer. II. Assess burden on nurses and infusion center team of patients using the PSCS.
III. Assess tolerability of PSCS. IV. Assess hair loss and recovery as assessed by the patient. V. Assess patient quality of life and satisfaction with treatment.
OUTLINE:
Patients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions.
After completion of study, patients are followed up for 1 year.
- Being tested
- Cold Cap Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Cap TherapyDevice
Also called Cold Cap, Paxman Scalp Cooling System, PSCS, Scalp Cooling
Undergo scalp cooling
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (PSCS) | Experimental | Patients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions. Receives: Device: Cold Cap Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in hair preservation
Hair loss will be measured by the patient according to the Dean Score. (Grade 0: no hair loss, grade 1: > 0 - 25%; grade 2: > 25 - 50%; grade 3: > 50 - 75%; grade 4: > 75%). Hair preservation was defined as hair loss no more than grade 2.
Measured: At 4 weeks after completion of the 6th chemotherapy cycle
Secondary outcomes (5)
Incidence of adverse events of PSCS
Will be determined by spontaneous reporting of adverse events and negative scalp changes determined by physical examination. Frequency tables will be used to summarize these events.
Measured: At 4 weeks, 3 months, and 6 months following the conclusion of 6 cycles of chemotherapy
Burden on nurses and infusion center team
The workload impact will be assessed via surveys distributed to nurses, and descriptive analysis will be used to explore the collected data.
Measured: Up to 1 year
Tolerability of PSCS
Will be determined by the proportion of patients who completed all planned cycles of chemotherapy using the PSCS will be assessed (including 95% CI).
Measured: Up to 1 year
Hair loss recovery
Patient self-assessment of hair loss at each chemotherapy infusion.
Measured: Up to 1 year
Patients quality of life
Will be measured by EORTC-QLQ-30 quality of life questionnaire. Changes will be summarized descriptively and comparison with baseline will be carried out using paired t-test (or non-parametric paired test when suitable). In addition, repeated measures one-way ANOVA will also be used where appropriate to evaluate changes over time.
Measured: Up to 30 days after the last dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start14 Dec 2022 (estimated)
- Primary completion14 Nov 2023 (estimated)
- Study completion14 Nov 2023 (estimated)
Why it stopped: PI decided to withdraw
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James R Waisman, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533320
- Sponsor's protocol ID
- 21030
- Other IDs
- NCI-2022-06837, 21030, P30CA033572
- Status last verified
- Feb 2023
- First submitted
- 6 Sep 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Benefits of The Portable Scalp Cooling System (PSCS) in Metastatic Breast Cancer Patients on Taxane-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT05533320
- Acronym / sponsor ID
- 21030
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided to withdraw
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Dec 2022 (estimated)
- Primary completion
- 14 Nov 2023 (estimated)
- Study completion
- 14 Nov 2023 (estimated)
- First posted
- 9 Sep 2022 (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.
This clinical trial evaluates the benefits of a portable scalp cooling system (PSCS) for improving chemotherapy-induced hair loss in patients with breast cancer that has spread to other places in the body (metastatic) and are undergoing taxane-based chemotherapy. The PSCS is a new system designed to reduce chemotherapy induced hair loss. The PSCS is designed as a portable unit, allowing patients to leave the infusion center after chemotherapy is completed and finish scalp cooling at home. PSCS may help improve chemotherapy-induced hair loss in patients with metastatic breast cancer receiving chemotherapy.
Detailed description
PRIMARY OBJECTIVE:
- Measure efficacy of scalp cooling for patients undergoing taxane based chemotherapy for metastatic breast cancer.
SECONDARY OBJECTIVES:
- Assess safety of PSCS in treating patients with metastatic breast cancer. II. Assess burden on nurses and infusion center team of patients using the PSCS.
III. Assess tolerability of PSCS. IV. Assess hair loss and recovery as assessed by the patient. V. Assess patient quality of life and satisfaction with treatment.
OUTLINE:
Patients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions.
After completion of study, patients are followed up for 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (PSCS) | Experimental | Device: Cold Cap Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Documented informed consent of the participant
- Age: >= 18 years
- Eastern Cooperative Oncology Group (ECOG) =< 2
- Ability to read and understand English or Spanish for questionnaires
- Documented diagnosis of metastatic breast cancer with at least a 6 month life expectancy
Key exclusion criteria (13 listed)
- Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
- A history of whole brain radiation with persistent hair thinning or alopecia, or concurrent whole brain radiation therapy
- Exposure to other investigational agents, drugs, device or procedure that may cause hair loss
- Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
- Any cutaneous scalp metastases
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 |
|---|---|---|
| Cold Cap TherapyAlso: Cold Cap, Paxman Scalp Cooling System, PSCS, Scalp CoolingUndergo scalp cooling | Device | Supportive care (PSCS) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (PSCS) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (PSCS) |
Primary outcome
Success in hair preservation
Time frame: At 4 weeks after completion of the 6th chemotherapy cycle
Hair loss will be measured by the patient according to the Dean Score. (Grade 0: no hair loss, grade 1: > 0 - 25%; grade 2: > 25 - 50%; grade 3: > 50 - 75%; grade 4: > 75%). Hair preservation was defined as hair loss no more than grade 2.
5 secondary outcomes
Incidence of adverse events of PSCS
Time frame: At 4 weeks, 3 months, and 6 months following the conclusion of 6 cycles of chemotherapy
Burden on nurses and infusion center team
Time frame: Up to 1 year
Tolerability of PSCS
Time frame: Up to 1 year
Hair loss recovery
Time frame: Up to 1 year
Patients quality of life
Time frame: Up to 30 days after the last dose of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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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.
James R Waisman principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Cold Cap Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by City of Hope Medical Center.
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 11 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: withdrawn, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Success in hair preservation (time frame: At 4 weeks after completion of the 6th chemotherapy cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2023.