Clinical trial NCT04678544: Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients
Official title: A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm, Breast
Keywords: Scalp cooling system
Randomized controlled trial
Permanent-Chemotherapy-Induced Alopecia
Chemotherapy-Induced Alopecia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Paxman
First posted: 2020-12-22
Enrollment: 170
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial, Single center
Primary purpose: PREVENTION

Brief summary: This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in women 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/Taxane will participate in the study. The study design is an 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. The 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 effects.

After the RCT, only patients who were expected to receive 4, 6, or 8 cycles of chemotherapy with an anthracycline regimen were further enrolled in the intervention group as a single-arm trial.

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 a 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 the prevention of permanent CIA(PCIA). This study aims to examine the impact of scalp cooling on the 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 a 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 the intervention group will have applied scalp cooling during 4 or 6 cycles of their chemotherapy whereas participants in the control group will be observed.

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

After the RCT, only patients who were expected to receive 4, 6, or 8 cycles of chemotherapy with an anthracycline regimen were further enrolled in the intervention group as a single-arm trial.

Eligibility 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)
* For the additional single arm, patients who expected to receive 4, 6, or 8 cycles of Adriamycin or Taxance chemotherapy regimen as neoadjuvant or adjuvant chemotherapy with curative intent (e.g., AC, TC, TCHP, or AC+T).

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

Primary outcomes:
measure: Permanent chemotherapy-induced alopecia
timeFrame: 6 months (±2 months) after completion of chemotherapy and intervention
Secondary outcomes:
measure: Hair density and thickness during and after chemotherapy
timeFrame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention
measure: Distress due to chemotherapy-induced alopecia
timeFrame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention
measure: Quality of life (cancer related quality of life)
timeFrame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention
measure: Breast cancer related quality of life
timeFrame: Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention
measure: Patients reported outcomes
timeFrame: 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
measure: Global photographs
timeFrame: 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
Other outcomes:
measure: Side effect
timeFrame: 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
measure: Willingness to pay
timeFrame: 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
measure: Effort for managing hair
timeFrame: 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
measure: Characteristic of participants
timeFrame: 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
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Ilwon-ro 81, Gangnam-gu
Study officials:
affiliation: Samsung Medical Center
name: Jin Seok Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Batchelor D. Hair and cancer chemotherapy: consequences and nursing care--a literature study. Eur J Cancer Care (Engl). 2001 Sep;10(3):147-63. doi: 10.1046/j.1365-2354.2001.00272.x.
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.
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.
citation: 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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: Bulow J, Friberg L, Gaardsting O, Hansen M. Frontal subcutaneous blood flow, and epi- and subcutaneous temperatures during scalp cooling in normal man. Scand J Clin Lab Invest. 1985 Oct;45(6):505-8. doi: 10.3109/00365518509155250.
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.
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.
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.
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.
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.
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.