Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer
Primary Purpose
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold Cap Therapy
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Anatomic Stage IV Breast Cancer AJCC v8
Eligibility Criteria
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (PSCS)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Hair loss recovery
Patient self-assessment of hair loss at each chemotherapy infusion.
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.
Full Information
NCT ID
NCT05533320
First Posted
September 6, 2022
Last Updated
January 31, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05533320
Brief Title
Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer
Official Title
Evaluation Of Benefits of The Portable Scalp Cooling System (PSCS) in Metastatic Breast Cancer Patients on Taxane-Based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI decided to withdraw
Study Start Date
December 14, 2022 (Anticipated)
Primary Completion Date
November 14, 2023 (Anticipated)
Study Completion Date
November 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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:
I. Measure efficacy of scalp cooling for patients undergoing taxane based chemotherapy for metastatic breast cancer.
SECONDARY OBJECTIVES:
I. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (PSCS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cold Cap Therapy
Other Intervention Name(s)
Cold Cap, Paxman Scalp Cooling System, PSCS, Scalp Cooling, Scalp Cryotherapy, Scalp Hypothermia
Intervention Description
Undergo scalp cooling
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Success in hair preservation
Description
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.
Time Frame
At 4 weeks after completion of the 6th chemotherapy cycle
Secondary Outcome Measure Information:
Title
Incidence of adverse events of PSCS
Description
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.
Time Frame
At 4 weeks, 3 months, and 6 months following the conclusion of 6 cycles of chemotherapy
Title
Burden on nurses and infusion center team
Description
The workload impact will be assessed via surveys distributed to nurses, and descriptive analysis will be used to explore the collected data.
Time Frame
Up to 1 year
Title
Tolerability of PSCS
Description
Will be determined by the proportion of patients who completed all planned cycles of chemotherapy using the PSCS will be assessed (including 95% CI).
Time Frame
Up to 1 year
Title
Hair loss recovery
Description
Patient self-assessment of hair loss at each chemotherapy infusion.
Time Frame
Up to 1 year
Title
Patients quality of life
Description
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.
Time Frame
Up to 30 days after the last dose of treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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)
Exclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Waisman
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer
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