Effect of a scalp cooling device on alopecia inwomen undergoing chemotherapy for breast cancer: The SCALP randomized clinical trial

JAMA - Journal of the American Medical Association

Volumn 317, Issue 6, 2017, Pages 596-605

  Nangia, Julie ^a   Wang, Tao ^a   Osborne, Cynthia ^b   Niravath, Polly ^a,c   Otte, Kristen ^a   Papish, Steven ^d   Holmes, Frankie ^b   Abraham, Jame ^e   Lacouture, Mario ^f   Courtright, Jay ^b   Paxman, Richard ^g   Rude, Mari ^a   Hilsenbeck, Susan ^a   Osborne, Kent ^a   Rimawi, Mothaffar ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b TEXAS ONCOLOGY   (United States)

^c HOUSTON METHODIST HOSPITAL   (United States)

^d UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^e LERNER RESEARCH INSTITUTE   (United States)

^f MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^g Paxman Coolers Limited   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CARBOPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; PACLITAXEL; PERTUZUMAB; TRASTUZUMAB; ANTHRACYCLINE; BRIDGED COMPOUND; TAXANE; TAXOID;

ALOPECIA; ANXIETY; ARTICLE; BODY IMAGE SCALE; BREAST CANCER; CANCER CHEMOTHERAPY; CHILL; CONTROLLED STUDY; DEPRESSION; DERMATOLOGICAL EQUIPMENT; DIZZINESS; DRY SKIN; EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER QUALITY OF LIFE QUESTIONNAIRE CORE 30; FEMALE; HAIR; HEADACHE; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; PAIN; PARESTHESIA; PATIENT MONITORING; PRURITUS; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCALP COOLING DEVICE; SCALP PAIN; SINUS PAIN; SKIN DISEASE; SKIN ULCER; SUBCUTANEOUS TISSUE DISORDER; TREATMENT RESPONSE; UNITED STATES; WIG; ADULT; ADVERSE EFFECTS; AGED; BREAST NEOPLASMS; CHEMICALLY INDUCED; CLINICAL TRIAL; DEVICES; EARLY TERMINATION OF CLINICAL TRIAL; INDUCED HYPOTHERMIA; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PRIMARY PREVENTION; PROCEDURES; SCALP;

ADULT; AGED; ALOPECIA; ANTHRACYCLINES; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; BRIDGED-RING COMPOUNDS; EARLY TERMINATION OF CLINICAL TRIALS; FEMALE; HUMANS; HYPOTHERMIA, INDUCED; MIDDLE AGED; PRIMARY PREVENTION; QUALITY OF LIFE; SCALP; TAXOIDS;

EID: 85014707188     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2016.20939     Document Type: Article

References (33)

1. Zdenkowski N, Tesson S, Lombard J, et al. Supportive care of women with breast cancer: key concerns and practical solutions. Med J Aust. 2016; 205(10):471-475.
2. Trusson D, Pilnick A. The role of hair loss in cancer identity: perceptions of chemotherapyinduced alopecia among women treated for early-stage breast cancer or ductal carcinoma in situ [published online April 11, 2016]. Cancer Nurs. 2016. doi:10.1097/NCC.0000000000000373
3. van den Hurk CJ. Safety and Effectiveness of Scalp Cooling in Cancer Patients Undergoing Cytotoxic Treatment. Leiden, the Netherlands: Gildeprint Drukkerijen; 2013.
4. Massey CS. A multicentre study to determine the efficacy and patient acceptability of the Paxman Scalp Cooler to prevent hair loss in patients receiving chemotherapy. Eur J Oncol Nurs. 2004;8 (2):121-130.
5. Lemieux J, Desbiens C, Hogue JC. Breast cancer scalp metastasis as firstmetastatic site after scalp cooling: two cases of occurrence after 7- and 9-year follow-up. Breast Cancer Res Treat. 2011;128(2):563-566.
6. van de Sande MA, van den Hurk CJ, Breed WP, Nortier JW. Allow scalp cooling during adjuvant chemotherapy in patients with breast cancer; scalp metastases rarely occur [in Dutch]. Ned Tijdschr Geneeskd. 2010;154:A2134.
7. Lemieux J, Amireault C, Provencher L, Maunsell E. Incidence of scalp metastases in breast cancer: a retrospective cohort study in women who were offered scalp cooling. Breast Cancer Res Treat. 2009;118(3):547-552.
8. Christodoulou C, Tsakalos G, Galani E, Skarlos DV. Scalp metastases and scalp cooling for chemotherapy-induced alopecia prevention. Ann Oncol. 2006;17(2):350.
9. van den Hurk CJ, van de Poll-Franse LV, Breed WP, Coebergh JW, Nortier JW. Scalp cooling to prevent alopecia after chemotherapy can be considered safe in patients with breast cancer. Breast. 2013;22(5):1001-1004.
10. Sneeuw KC, Aaronson NK, Yarnold JR, et al. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer, 2: relationship with psychosocial functioning. Radiother Oncol. 1992;25(3):160-166.
11. Münstedt K, Manthey N, Sachsse S, Vahrson H. Changes in self-concept and body image during alopecia induced cancer chemotherapy. Support Care Cancer. 1997;5(2):139-143.
12. van den Hurk CJ, Mols F, Vingerhoets AJ, Breed WP. Impact of alopecia and scalp cooling on the well-being of breast cancer patients. Psychooncology. 2010;19(7):701-709.
13. Pozo-Kaderman C, Kaderman RA, Toonkel R. The psychosocial aspects of breast cancer. Nurse Pract Forum. 1999;10(3):165-174.
14. Kornblith AB. Psychosocial adaptation of cancer survivors. In: Holland JC, BreitbartW, Jacobsen PB, et al, eds. Psycho-Oncology. Oxford, England: Oxford University Press; 1998:223-254.
15. Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A; EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual. 3rd ed. Brussels, Belgium: European Organisation for Research & Treatment of Cancer; 2001.
16. GL Assessment. Hospital Anxiety and Depression Scale (HADS). http://www.gl-assessment.co.uk/products/hospital-anxiety -and-depression-scale/hospital-anxiety-and -depression-scale-faqs. Accessed November 10, 2016.
17. Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001;37(2):189-197.
18. Shin H, Jo SJ, Kim DH, Kwon O, Myung SK. Efficacy of interventions for prevention of chemotherapy-induced alopecia: a systematic review and meta-analysis. Int J Cancer. 2015;136(5): E442-E454.
19. Mols F, van den Hurk CJ, Vingerhoets AJ, Breed WP. Scalp cooling to prevent chemotherapy-induced hair loss: practical and clinical considerations. Support Care Cancer. 2009; 17(2):181-189.
20. van den Hurk C, Peerbooms M, Komen M, Nortier H, BreedW. Multicenter results of scalp cooling to prevent chemotherapy-induced alopecia in 1500 breast cancer patients. Poster presented at: 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium; December 6-10, 2011; San Antonio, TX.
21. 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;51(4):497-504.
22. Edelstyn GA, MacDonald M, MacRae KD. Doxorubicin-induced hair loss and possible modification by scalp cooling. Lancet. 1977;2(8031): 253-254.
23. Giaccone G, Di Giulio F, Morandini MP, Calciati A. Scalp hypothermia in the prevention of doxorubicin-induced hair loss. Cancer Nurs. 1988;11(3):170-173.
24. Ron IG, Kalmus Y, Kalmus Z, Inbar M, Chaitchik S. Scalp cooling in the prevention of alopecia in patients receiving depilating chemotherapy. Support Care Cancer. 1997;5(2): 136-138.
25. Macduff C, Mackenzie T, Hutcheon A, Melville L, Archibald H. The effectiveness of scalp cooling in preventing alopecia for patients receiving epirubicin and docetaxel. Eur J Cancer Care (Engl). 2003;12(2):154-161.
26. Satterwhite B, ZimmS. The use of scalp hypothermia in the prevention of doxorubicininduced hair loss. Cancer. 1984;54(1):34-37.
27. Kennedy M, Packard R, Grant M, Padilla G, Presant C, Chillar R. The effects of using Chemocap on occurrence of chemotherapy-induced alopecia. Oncol Nurs Forum. 1983;10(1):19-24.
28. Parker R. The effectiveness of scalp hypothermia in preventing cyclophosphamideinduced alopecia. Oncol Nurs Forum. 1987;14(6): 49-53.
29. Spaeth D, Luporsi E, Weber B, et al. Efficacy and safety of cooling helmets (CH) for the prevention of chemotherapy-induced alopecia (CIA): a prospective study of 911 patients (pts). J Clin Oncol. 2008;26(15S):9564.
30. Breed WPM, van den Hurk CJG, Peerbooms M. Presentation, impact and prevention of chemotherapy-induced hair loss: scalp cooling potentials and limitations. Expert Rev Dermatol. 2011;6(1):109-125. doi:10.1586/edm.10.76
31. Rugo HS, Klein P, Melin SA, et al. Clinical performance of the DigniCap system, a scalp hypothermia system, in preventing chemotherapy-induced alopecia. Poster presented at: 2015 ASCO Annual Meeting; May 29, 2015; Chicago, IL. Abstract 9518.
32. Komen MM, Smorenburg CH, van den Hurk CJ, Nortier JW. Factors influencing the effectiveness of scalp cooling in the prevention of chemotherapy-induced alopecia. Oncologist. 2013; 18(7):885-891.
33. Lemieux J, Maunsell E, Provencher L. Chemotherapy-induced alopecia and effects on quality of life among women with breast cancer: a literature review. Psychooncology. 2008;17(4): 317-328.