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

Neoplasm, Breast Clinical Trial

Official title:

A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678544
• Other study ID #: PAXMAN
• Status: Completed
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: December 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: August 30, 2022
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Breast Neoplasms
• Neoplasm, Breast

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Ilwon-ro 81, Gangnam-gu	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Paxman

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (22)

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Breed WP. What is wrong with the 30-year-old practice of scalp cooling for the prevention of chemotherapy-induced hair loss? Support Care Cancer. 2004 Jan;12(1):3-5. doi: 10.1007/s00520-003-0551-8. Epub 2003 Nov 13. — View Citation

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Cho J, Choi EK, Kim IR, Im YH, Park YH, Lee S, Lee JE, Yang JH, Nam SJ. Development and validation of Chemotherapy-induced Alopecia Distress Scale (CADS) for breast cancer patients. Ann Oncol. 2014 Feb;25(2):346-51. doi: 10.1093/annonc/mdt476. Epub 2013 Dec 29. — View Citation

Choi EK, Kim IR, Chang O, Kang D, Nam SJ, Lee JE, Lee SK, Im YH, Park YH, Yang JH, Cho J. Impact of chemotherapy-induced alopecia distress on body image, psychosocial well-being, and depression in breast cancer patients. Psychooncology. 2014 Oct;23(10):1103-10. doi: 10.1002/pon.3531. Epub 2014 Mar 24. — View Citation

Dunnill CJ, Al-Tameemi W, Collett A, Haslam IS, Georgopoulos NT. A Clinical and Biological Guide for Understanding Chemotherapy-Induced Alopecia and Its Prevention. Oncologist. 2018 Jan;23(1):84-96. doi: 10.1634/theoncologist.2017-0263. Epub 2017 Sep 26. — View Citation

Gregory RP, Cooke T, Middleton J, Buchanan RB, Williams CJ. Prevention of doxorubicin-induced alopedia by scalp hypothermia: relation to degree of cooling. Br Med J (Clin Res Ed). 1982 Jun 5;284(6330):1674. doi: 10.1136/bmj.284.6330.1674. No abstract available. — View Citation

Janssen FP, Rajan V, Steenbergen W, van Leeuwen GM, van Steenhoven AA. The relationship between local scalp skin temperature and cutaneous perfusion during scalp cooling. Physiol Meas. 2007 Aug;28(8):829-39. doi: 10.1088/0967-3334/28/8/006. Epub 2007 Jul 6. — View Citation

Kang D, Kim IR, Choi EK, Im YH, Park YH, Ahn JS, Lee JE, Nam SJ, Lee HK, Park JH, Lee DY, Lacouture ME, Guallar E, Cho J. Permanent Chemotherapy-Induced Alopecia in Patients with Breast Cancer: A 3-Year Prospective Cohort Study. Oncologist. 2019 Mar;24(3):414-420. doi: 10.1634/theoncologist.2018-0184. Epub 2018 Aug 17. — View Citation

Kang D, Kim IR, Im YH, Park YH, Ahn JS, Lee JE, Nam SJ, Park H, Kim E, Lee HK, Lee DY, Cho J. Quantitative changes in skin composition parameters due to chemotherapy in breast cancer patients: a cohort study. Breast Cancer Res Treat. 2015 Aug;152(3):675-82. doi: 10.1007/s10549-015-3502-4. Epub 2015 Jul 22. — View Citation

Kang D, Kim IR, Park YH, Im YH, Zhao D, Guallar E, Ahn JS, Cho J. Impact of a topical lotion, CG428, on permanent chemotherapy-induced alopecia in breast cancer survivors: a pilot randomized double-blind controlled clinical trial (VOLUME RCT). Support Care Cancer. 2020 Apr;28(4):1829-1837. doi: 10.1007/s00520-019-04982-z. Epub 2019 Jul 23. — View Citation

Kim IR, Cho J, Choi EK, Kwon IG, Sung YH, Lee JE, Nam SJ, Yang JH. Perception, attitudes, preparedness and experience of chemotherapy-induced alopecia among breast cancer patients: a qualitative study. Asian Pac J Cancer Prev. 2012;13(4):1383-8. doi: 10.7314/apjcp.2012.13.4.1383. — View Citation

Kim SN, Lee SY, Choi MH, Joo KM, Kim SH, Koh JS, Park WS. Characteristic features of ageing in Korean women's hair and scalp. Br J Dermatol. 2013 Jun;168(6):1215-23. doi: 10.1111/bjd.12185. — View Citation

Kluger N, Jacot W, Frouin E, Rigau V, Poujol S, Dereure O, Guillot B, Romieu G, Bessis D. Permanent scalp alopecia related to breast cancer chemotherapy by sequential fluorouracil/epirubicin/cyclophosphamide (FEC) and docetaxel: a prospective study of 20 patients. Ann Oncol. 2012 Nov;23(11):2879-2884. doi: 10.1093/annonc/mds095. Epub 2012 May 9. — View Citation

Komen MM, Breed WP, Smorenburg CH, van der Ploeg T, Goey SH, van der Hoeven JJ, Nortier JW, van den Hurk CJ. Results of 20- versus 45-min post-infusion scalp cooling time in the prevention of docetaxel-induced alopecia. Support Care Cancer. 2016 Jun;24(6):2735-41. doi: 10.1007/s00520-016-3084-7. Epub 2016 Jan 25. — View Citation

Komen MMC, Smorenburg CH, Nortier JWR, van der Ploeg T, van den Hurk CJG, van der Hoeven JJM. Results of scalp cooling during anthracycline containing chemotherapy depend on scalp skin temperature. Breast. 2016 Dec;30:105-110. doi: 10.1016/j.breast.2016.09.007. Epub 2016 Sep 28. — View Citation

Lane P, Vichi P, Bain DL, Tritton TR. Temperature dependence studies of adriamycin uptake and cytotoxicity. Cancer Res. 1987 Aug 1;47(15):4038-42. — View Citation

McGarvey EL, Baum LD, Pinkerton RC, Rogers LM. Psychological sequelae and alopecia among women with cancer. Cancer Pract. 2001 Nov-Dec;9(6):283-9. doi: 10.1046/j.1523-5394.2001.96007.x. — View Citation

Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, Holmes F, Abraham J, Lacouture M, Courtright J, Paxman R, Rude M, Hilsenbeck S, Osborne CK, Rimawi M. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):596-605. doi: 10.1001/jama.2016.20939. — View Citation

Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bageman E, D'Agostino RB Jr, Ver Hoeve ES, Esserman L, Cigler T. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer. JAMA. 2017 Feb 14;317(6):606-614. doi: 10.1001/jama.2016.21038. — View Citation

Rugo HS, Melin SA, Voigt J. Scalp cooling with adjuvant/neoadjuvant chemotherapy for breast cancer and the risk of scalp metastases: systematic review and meta-analysis. Breast Cancer Res Treat. 2017 Jun;163(2):199-205. doi: 10.1007/s10549-017-4185-9. Epub 2017 Mar 8. — View Citation

van den Hurk CJ, Peerbooms M, van de Poll-Franse LV, Nortier JW, Coebergh JW, Breed WP. Scalp cooling for hair preservation and associated characteristics in 1411 chemotherapy patients - results of the Dutch Scalp Cooling Registry. Acta Oncol. 2012 Apr;51(4):497-504. doi: 10.3109/0284186X.2012.658966. Epub 2012 Feb 6. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effect	Potential side-effect including discomfort due to the cold, headache, dizziness or vomiting.	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
Other	Willingness to pay	Willingness to pay to use scalp cooling by self-developed questionnaire.	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
Other	Effort for managing hair	Usual care for hair and scalp, type of shampoo, wig	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
Other	Characteristic of participants	Demographic information including age, education, marital status, working status, income, smoking and drinking history, medication, exposure-time to sunlight and co-morbidities	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
Primary	Permanent chemotherapy-induced alopecia	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.	6 months (±2 months) after completion of chemotherapy and intervention
Secondary	Hair density and thickness during and after chemotherapy	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).	Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention
Secondary	Distress due to chemotherapy-induced alopecia	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	Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention
Secondary	Quality of life (cancer related quality of life)	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.	Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention
Secondary	Breast cancer related quality of life	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.	Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention
Secondary	Patients reported outcomes	Self-reported hair loss will be assessed by using Korean version of PRO-CTCAE.	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
Secondary	Global photographs	Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject by using Canon EOS 70D.	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