COLD CAPPING RESEARCH
Adverse Events Research
Rezayee et el published in Current Problems in Cancer 2021
Looked at the tolerability and safety of manual cold capping with Penguin caps (using standardised questionnaires). Only 1 patient reported a side effect clearly related to cold capping, a sore head. 90% endorsed that cold capping with Penguin was worthwhile and 100% would recommend to others. 80% would do it again.
https://www.sciencedirect.com/science/article/pii/S2666621921000454?via%3DihubKimoshita et al published in Frontiers of Oncology the Hope Study 2019
No patient (48 in the study) developed serious adverse events related to the Paxman scalp-cooling device.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691158/Rogo et al published in Breast Cancer Research in Treatment 2017
This meta-analysis looked at the risk of scalp metastases in breast cancer when scalp cooling was used. An American meta-analysis shows there was no difference in the incidents of scalp metastases between scalp cooled and non-scalp cooled patients. 0.6% of the scalp cooled and 0.4% of the non-scalp cooled patients showed metastases. There was no statistical difference between the groups. Scalp metastasis appears rare in breast cancer and the frequency is not affected by scalp cooling.
https://link.springer.com/article/10.1007%2Fs10549-017-4185-9Rice et al published in Breast Cancer Research and Treatment 2017
The most common toxicity was headache, reported by 78.5% of patients with mean pain level 37/100. Satisfaction among those who completed Penguin scalp cooling (SC) and FUP ranged from 74 to 100%. All patients who completed SC/FUP recommended Penguin.
https://pubmed.ncbi.nlm.nih.gov/28921303/(Article available on request)
Belum et al published in Breast Cancer Res Treat 2016
Case reports of manual cold capping adverse effects. The conclusion was that most of these adverse effects were related to poor cold capping technique e.g. not adequately protecting exposed skin. Standardised cold capping education/technique was recommended.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5612426/#__ffn_sectitleBetticher et al published in Support Care Cancer 2013
Study comparing Paxman scalp cooling machines and manual cold capping. Adverse events were reported in 5% which was mainly the sensation of cold and 13% of patients discontinued. There was no difference between the two types of cold capping in terms of tolerability.
https://pubmed.ncbi.nlm.nih.gov/23636645/(Article available on request)
Van den Hurk et al 2012 Actor Oncologica
Scalp cooling was stopped because of intolerance in only 3% of patients.
https://www.tandfonline.com/doi/full/10.3109/0284186X.2012.658966Penguin Cold Caps Efficacy
Penguin cold caps was established in 1997 and claim “average hair retention >80% even with strong regimes”. This claim comes from recent studies plus monitoring success in terms of feedback and cap hire duration (e.g. 1 month hire presumed a treatment failure). The recommended duration of post chemotherapy infusion cold capping (often 4 hours plus) is based on a research study (Komen 2018) which showed that longer cooling leads to reduced hair loss and also clinical experience /feedback from chemotherapy nurses.
Penguin is widely used internationally, and professional cappers are often used in the USA. The founders of The Rapunzel Project in the USA have observed that Penguin is often more successful with challenging chemotherapy such as anthracyclines.
Published research is limited but suggests that Penguin cold caps are effective in reducing Chemotherapy Induced Alopecia CIA.
Rezayee et el published in Current Problems in Cancer 2021
A pilot study of care-giver training to maximise Penguin manual cold capping efficacy. They also developed a questionnaire to help with decision making for whether to cold cap or not and looked at the subjective experience of cold capping.
The study was a small pilot involving 10 women who were receiving a range of chemotherapies. Paclitaxel/ Carboplatin 5/10, AC-T 3/10, TC Docetaxel/cyclophosphamide 1/10, Paclitaxel 1/10. 80% of the women were successful in keeping more than 50% of hair based on Dean’s alopecia scale 30 days post treatment. 2/10 discontinued cold capping prematurely. The study found that training cold capping assistants was helpful and that many people would find the process complicated without assistance.
https://www.sciencedirect.com/science/article/pii/S2666621921000454?via%3DihubRice et al published in Breast Cancer Research and Treatment 2017
A registry of Penguin cold cap success rates with a range of chemotherapies. This study involving 103 patients and outcomes included both patient and doctor CIA ratings.
Overall, 61% of patients successfully prevented CIA; impact was regimen specific: TCH 100%, TC × 4 84%, TC × 5-6 50%, P/AC 43%, AC/P 20%. The most success was for shorter taxane based chemotherapy. In combination anthracycline chemotherapy, there was more success when the taxane was given before the anthracycline.
https://pubmed.ncbi.nlm.nih.gov/28921303/(Article available on request)
Betticher et al published in Support Care Cancer 2013
Compared manual cold caps (presumed to be Penguin) with the Paxman machine. 238 patients were included in the trial. Cooling with both Paxman and the cold cap reduced alopecia by 78% on Docetaxel mono therapy. The cold cap and Paxman were equally effective and 45 minutes after infusion cooling was adequate. There seemed to be no difference between the Paxman system and the manual cold cap in terms of efficacy and tolerability.
https://pubmed.ncbi.nlm.nih.gov/23636645/(Article available on request)
Kargar et al published in Journal of Advanced Nursing 2011
A small study with 63 patients. 50% of patients had a successful outcome (Grade 1 or 2) by the sixth cycle of chemotherapy on a wide of range chemotherapies and using sub-optimal capping technique due to limited resources.
https://pubmed.ncbi.nlm.nih.gov/21635283/Pek et al published in European Journal of Oncology Nursing 2000.
Assessed patients receiving FEC chemotherapy using Penguin cold caps. A small study of 10 patients using Penguin caps for 2 hours during FEC chemotherapy. Results were that 70% using Penguin caps did not require a wig at the end of treatment versus 100% of the 5 patients in the control group needing a wig.
https://pubmed.ncbi.nlm.nih.gov/12849021/(Article available on request)
Paxman Scalp Cooling Machine Research
Paxman scalp cooling machines were first invented in 1997 and are now widely used around the world. The Paxman website includes links to many research trials.
The website also has a very useful Decision Making Guide with efficacy percentages for keeping 50% or more of hair based largely on a large international registry’s data. The international registry CHILL is an ongoing study of hair loss rates and the effects of cold capping with Paxman.
https://coldcap.com/cold-capping/decision-making-guide/https://www.scalpcooling.org/chill-study
Paxman’s efficacy seems to be largely dependent on chemotherapy type, but with wide individual variation. For example, taxane monotherapy can have efficacy from 70-95%, TC around 50%, AC-T 34% (T-AC said to be more successful). There also seems to be differing efficacy between different ethnicity’s hair types.
Paxman is currently working on several research projects e.g. looking at improving success for combination chemotherapies.
1. Hair Retention Effacy
Ohsumi et al published in Supportive Care in Cancer 2020
Scalp cooling for female Japanese breast cancer patients receiving chemotherapy had a 54% success rate with Taxane and/or Anthracycline based chemotherapy. 69% received Docetaxel and Cyclophosphamide and 28% AC or EC followed by an Taxane. Scalp cooling was free for the first cycle after which there was a large charge and many people withdrew and were used as the control group. The rate of full hair loss after TC was 55% compared with 19% for AC followed by a Taxane.
https://www.oncobel.es/wp-content/uploads/2020/06/Japan-Study-Scalp-cooling-for-hair-loss-prevention-in-female-Japanese-breast-cancer-patients-receiving-neoadjuvant-chemotherapy-JAPAN-2020.pdfBajpai et al published in The Breast 2020
This study showed a 56.3% success rate and more rapid hair regrowth with Anthracycline and Taxane based chemotherapy in Indian breast cancer patients. The end point of this study was after four cycles of chemotherapy.
https://www.thebreastonline.com/article/S0960-9776(19)31111-7/fulltextGregory et al Scalp cooling pilot at Nelson Hospital NZ 2019
This pilot was funded by the NZBCF. The pilot included 11 patients on a variety of chemotherapy regimes. All of the patients retained more than 50% of hair and none needed a wig.
(Article not published and is available on request)
Komen et al published in Supportive Care in Cancer 2018
With the Paxman machine, extending the post-infusion time to 150 minutes improved the grade of alopecia but did not significantly improve the use of wig or head coverings. The usual length of time was 90 minutes post-infusion and the type of chemotherapy used was FEC.
https://link.springer.com/article/10.1007/s00520-018-4432-6Vasconcelos et al published in The Breast 2018
The study used the Paxman machine during T and EC-T chemotherapy. The degree of success varied greatly between chemotherapy regimes. Taxane monotherapy was 88%, weekly EC-T was 76% and three-weekly EC-T was 59% success. The study included 131 women and success was <50% hair loss and not requiring a wig. Overall success was 71% of women.
https://pubmed.ncbi.nlm.nih.gov/29660543/Nangia et al published in JAMA 2017.
A randomised control trial using the Paxman machine and different chemotherapies, different sites in the USA and 182 women with breast cancer. They found there was a difference in success depending on hospital site. This was thought to possibly be related to proper fitting of the cap. They found that 59% of women had successful hair retention on Taxane chemotherapy and 16% on Anthracycline chemotherapy. The exact type of chemotherapy was not defined in the published article. Success was defined as <50% hair loss and not requiring a wig.
According to the Paxman website, an update from the authors of the Nangia 2017 scalp trial was that there was an increase in difference between the cooling and non-cooling group. Taxane’s had a rate of 63% and Anthracycline’s 24.1%. (TC chemo was about 50%).
https://jamanetwork.com/journals/jama/fullarticle/2601500Komen et al published in Supportive Care in Cancer 2016
Found that 20 minutes versus 45 minutes post-infusion scalp cooling to prevent Docetaxel induced alopecia was as effective and led to shorter hospital stays. This was for Docetaxel monotherapy 75-100mgs 2-3 weekly.
https://www.paxman.com.br/downloads/estudos/results20versus45min.pdfVan den Hurk et al published in European Journal of Oncology 2013
Study included both Taxane and or Anthracycline based regimes and 246 patients including controls. There was a 40% reduction in the need to wear a wig or head covering in the scalp cooling group.
https://www.paxman.com.br/downloads/estudos/european-journal-oncology.pdfBetticher et al published in Supportive Care in Cancer 2013
238 patients, Docetaxel weekly or three-weekly. Treatment was deemed a success if the patient did not need to wear a wig at the end of treatment. No significant difference was found with hair retention between the manual cold capping and Paxman groups. This was noted to be an outdated protocol with Paxman currently suggesting a longer pre-cooling time of 30 minutes and a shorter post-cooling time of 20 minutes.
https://pubmed.ncbi.nlm.nih.gov/23636645/(Article available on request)
Van den Hurk et al published in Actor Oncologica 2012
Published results of the Dutch scalp cooling registry. A large study of 1141 patients at 28 different hospitals. Success was deemed as not wearing a wig/head covering at the end of chemotherapy. The best results were shown with patients on Taxane monotherapy. 94% of patients on Docetaxel and 81% of patients on Paclitaxel did not need to wear a head covering. The lowest success rate of 8% was seen with TAC a mixture of Taxanes and Anthracyclines given on the same day. Most of the chemotherapies were within 40-80% success. They did not seem to have TC listed on their chart graph. The Dutch Registry data is what is used for the Paxman Decision Guide.
https://www.tandfonline.com/doi/full/10.3109/0284186X.2012.6589662. Hair Regrowth Effacy
Bajpai et al published in The Breast 2020
This study showed a 56.3% success rate and more rapid hair regrowth with Anthracycline and Taxane based chemotherapy in Indian breast cancer patients. The end point of this study was after four cycles of chemotherapy.
https://www.thebreastonline.com/article/S0960-9776(19)31111-7/fulltextKimoshita et al published in Frontiers of Oncology the Hope Study 2019
Japanese study showed a minimum of 27% success with Anthracycline and Taxane based therapy using the Paxman scalp cooling system. More than 60% of patients were treated with TC regime Docetaxel/Cyclophosphamide and the remaining patients received AC. There was a difference between whether both assessors graded the alopecia or independently. It was 26% if both of the assessors determined alopecia and 60% when either clinical assessor judged independently.
85% of patients experienced an increase in hair volume more than 50% within 12 weeks after chemotherapy and 50% of the control group. 25% of those who had recovered from alopecia after 12 weeks in the scalp cooling group and only 8% in the control group. It was felt that scalp cooling resulted in a faster recovery of hair volume after chemotherapy even in patients for whom scalp cooling had failed to prevent chemotherapy induced alopecia. The Japanese head shape being different and the requirement to have two assessors judge the alopecia the same, may have led to lower results in this study. Paxman reports that the caps do not fit Japanese head shapes well.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691158/Elastogel Cold Caps
Prevention of persistent alopecia pCIA research
Martin et al published in Breast Cancer Research in Treatment 2018
Assessed the effect of scalp cooling on persistent alopecia following Docetaxel for breast cancer. Without scalp-cooling, Grade 2 alopecia (complete baldness requiring a wig) was seen in 10% of 358 patients on higher dose Docetaxel (400 CD and above) at 18 months follow-up. Grade 1 alopecia (less severe, not requiring a wig) was seen in 33-52% on Docetaxel. Noted that in most cases chemotherapy induced alopecia starts two weeks after the initial chemotherapy and starts to reverse 3-4 months after the termination of the final treatment. When scalp cooling with an Elasto-gel cap was used, there was no instances of Grade 2 persistent alopecia seen with high dose Docetaxel in 116 patients. It therefore seemed that scalp cooling is effective in preventing persistent alopecia from Docetaxel.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133184/