Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04678544
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
Paxman
Information provided by (Responsible Party):
Jin Seok Ahn, MD, Samsung Medical Center

Brief Summary:
This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. Female adults who are newly diagnosed with stage 1-3 breast cancer and expected to receive Adriamycin or/and Taxane will participate in the study. The study design is a open label, randomized controlled trial. The patients will be randomly assigned to intervention or control groups. Intervention patients will have applied scalp cooling during 4 or 6 cycles of their chemotherapy. Primary endpoint is the effectiveness of the PSCS2 for reducing permanent chemotherapy-induced alopecia. Secondary endpoints include chemotherapy-induced alopecia, distress due to chemotherapy induced alopecia, quality of life, and patient-reported alopecia related side effect.

Condition or disease Intervention/treatment Phase
Neoplasm, Breast Device: Scalp cooling system 2 Not Applicable

Detailed Description:

Adjuvant chemotherapy decreases the risk of recurrence. However, it has distressing side effects, including alopecia. Chemotherapy-induced alopecia (CIA) is a common and distressing side effect of many chemotherapy drugs. In previous study, more than half of the breast cancer patients experienced higher distress due to CIA during cancer treatment, and this distress was strongly associated with negative body image, overall health status, and psychosocial well-being. Recently scalp cooling has been known to be one of the effective options for hair loss prevention. However there was little information regarding the effect on prevention of permanent CIA(PCIA). This study aims to examine the impact of scalp cooling on prevention of PCIA as well as CIA.

Female adults who are newly diagnosed with stage 1-3 breast cancer and aged less than 70 years will be screened for plan of undergoing Adriamycin or/and Taxane regimen as neoadjuvant or adjuvant chemotherapy. Eligible patients will be randomly assigned to intervention or control groups (2:1 ratio). Patients in intervention group will have applied scalp cooling during 4 or 6 cycles of their chemotherapy whereas participants in control group will be observed.

The objective of the study is to examine whether Paxman scalp cooling system is effective in reducing PCIA in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. In addition, impact of Paxman scalp cooling on prevention of CIA, alopecia-related distress, quality of life and patient-reported alopecia related side effect will be also explored.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial, Single center
Masking: Single (Outcomes Assessor)
Masking Description: There will be no blindness of physician and patients. However, statisticians who will analyze the data will be blinded.
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients
Actual Study Start Date : December 23, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Intervention Group
Before the chemotherapy, patients in intervention group will use cooling cap 30 minutes before chemotherapy. Once chemotherapy drug be ready, patients will receive chemotherapy. After the chemotherapy, patients go to the cooling cap area (room) and wear the cooling cap additional 20 minute for Taxane and 90 minute for other drugs, respectively.
Device: Scalp cooling system 2
The investigational device which will be used in this study is the Paxman Scalp Cooling System 2. This device is manufactured by: Paxman Coolers Limited. This is a free-standing, electrically-powered, mobile refrigeration unit which circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap which is attached to, and covers, the top of the patient's head. The Paxman Scalp Cooling System is intended to be used for scalp cooling of patients who are receiving chemotherapy for the treatment of solid tumors, in order to reduce the risk of chemotherapy-induced alopecia.

No Intervention: Controlled Group
chemotherapy with usual care



Primary Outcome Measures :
  1. Permanent chemotherapy-induced alopecia [ Time Frame: 6 months (±2 months) after completion of chemotherapy and intervention ]
    Permanent chemotherapy-induced alopecia is defined as hair density or thickness less than two standard deviations (SDs) compared to the baseline mean (before chemotherapy) at 6 months (±2 months) after completion of chemotherapy. Hair density and thickness will be measured by using Folliscope 5.0, LeadM.


Secondary Outcome Measures :
  1. Hair density and thickness during and after chemotherapy [ Time Frame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention ]
    Hair density and thickness will be measured by using Folliscope 5.0, LeadM between 1st and 2nd intervention and at 1st clinical visit after chemotherapy compared to the baseline mean (before chemotherapy).

  2. Distress due to chemotherapy-induced alopecia [ Time Frame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention ]
    Chemotherapy-Induced Alopecia Distress Scale (CADS) will be used to demonstrate that the PSCS is effective in reducing distress due to chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy

  3. Quality of life (cancer related quality of life) [ Time Frame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention ]
    Quality of life will be measured using EORTC QLQ-C30. The QLQ-C30 is a cancer health-related quality-of-life questionnaire that has been widely used in clinical trials and investigations using patient reported outcome for individual patient management. It use a "past week" recall period. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of Quality of life.

  4. Breast cancer related quality of life [ Time Frame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention ]
    Quality of life will be measured using EORTC QLQ-BR23. The BR23 is a breast cancer specific module to measure health-related quality-of-life . It use a "past week" recall period. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of Quality of life.

  5. Patients reported outcomes [ Time Frame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention, and 6 months (±2 months) after completion of chemotherapy and intervention ]
    Self-reported hair loss will be assessed by using Korean version of PRO-CTCAE.

  6. Global photographs [ Time Frame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention, and 6 months (±2 months) after completion of chemotherapy and intervention ]
    Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject by using Canon EOS 70D.


Other Outcome Measures:
  1. Side effect [ Time Frame: At the beginning (1st day) of the 2nd cycle (each cycle is 21days), At the beginning of 3rd cycle of chemotherapy, At the beginning of 4th cycle of chemotherapy, At the beginning of 5th cycle of chemotherapy, and , At the beginning 6th of chemotherapy ]
    Potential side-effect including discomfort due to the cold, headache, dizziness or vomiting.

  2. Willingness to pay [ Time Frame: At the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy, and 6 months (±2 months) after completion of chemotherapy ]
    Willingness to pay to use scalp cooling by self-developed questionnaire.

  3. Effort for managing hair [ Time Frame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention, and 6 months (±2 months) after completion of chemotherapy ]
    Usual care for hair and scalp, type of shampoo, wig

  4. Characteristic of participants [ Time Frame: Smoking, drinking, medication and exposure-time to sunlight at baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), and 6m (±2m) after completion of chemotherapy, the others at only baseline ]
    Demographic information including age, education, marital status, working status, income, smoking and drinking history, medication, exposure-time to sunlight and co-morbidities



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed breast cancer, stage I-III
  • Expected to receive 4 or 6 cycles of Adriamycin or Taxance of chemotherapy regimen as neoadjuvant or adjuvant chemotherapy with curative intent (e.g., AC, TC, or TCHP)

Exclusion Criteria:

  • Any other concurrent malignancy including hematological malignancies
  • Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
  • Serum Albumin < 3.0
  • Subjects who are underweight (defined as a BMI < 17.5)
  • Subjects who have had previous chemotherapy exposure
  • Subjects with cold agglutinin disease or cold urticarial
  • Subject who had thyroid disease, diabetes or cardiac disease
  • Subject who had auto-immune disease
  • History of treatment due to alopecia
  • Subject who had scalp disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678544


Contacts
Layout table for location contacts
Contact: Nayeon Kim, MSN +82-2-3410-6603 ezhyang.kim@samsung.com
Contact: Danbee Kang, PhD +82-2-2148-7197 dbee.kang@skku.edu

Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center, Ilwon-ro 81, Gangnam-gu Recruiting
Seoul, Korea, Republic of, 06351
Contact: Nayeon Kim, MSN    +82-2-3410-6603    ezhyang.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Paxman
Investigators
Layout table for investigator information
Principal Investigator: Jin Seok Ahn, MD, PhD Samsung Medical Center
Publications:

Layout table for additonal information
Responsible Party: Jin Seok Ahn, MD, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04678544    
Other Study ID Numbers: PAXMAN
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The protocol summary, and informed consent form will be made available on clinicaltrials.gov when required.

Requests for study protocol and informed consent form can be shared after starting recruit. Requests for deidentified individual participant data can be made beginning 24 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: jinseok.ahn@samsung.com or jcho@skku.edu

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame:

Requests for study protocol and informed consent form can be shared after starting recruit.

Requests for deidentified individual participant data can be made beginning 24 months after publication and for up to 36 months post publication.

Access Criteria: People who send a request e-mail and be received confirmation from : jinseok.ahn@samsung.com or jcho@skku.edu

Layout table for additional information
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
Keywords provided by Jin Seok Ahn, MD, Samsung Medical Center:
Scalp cooling system
Randomized controlled trial
Permanent-Chemotherapy-Induced Alopecia
Chemotherapy-Induced Alopecia
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Neoplasms by Site
Neoplasms
Breast Diseases