1637 - "Randomised controlled trial of Scalp Cooling (SC) for the prevention of Chemotherapy Induced Alopecia (CIA)”

Background

The only randomized trial of SC to prevent the distressing chemo-toxicity, CIA did not evaluate its effect on hair regrowth (HR) and was conducted in a predominantly taxane (T) treated population. We conducted a randomized trial of SC in a setting of anthracycline (A) and taxane chemotherapy and assessed its effect on CIA and HR.

Methods

Non-metastatic breast cancer women undergoing (neo)adjuvant chemotherapy were randomized to receive SC using Paxman scalp cooling system during every cycle of chemotherapy, or no SC. The primary end point was successful hair preservation (HP) assessed clinically and by review of 5 photographs, using the CTCAE version 4.0 scale (defined as grade 0 = no, grade1 = < 50% hair loss, not requiring a wig) after the 4 cycles or 12 weeks of chemotherapy. Secondary endpoints were HR at 6 and 12 weeks after completion of chemotherapy, adverse events and comparative quality of life scores.

Results

Between December 2016 and July 2018, 51 patients, with median age 38 (21-58) years, were randomized to SC (34) or control arm (17) in a 2:1 ratio. 25/51 (49%) patients received A followed by T and two arms were balanced with respect to this factor. Modified intension to treat population (32) comprised of women who received at least one cycle of chemotherapy. HP rate was significantly higher in SC arm (18/32, 56.3%) compared to control arm (0/17, 0%; difference 56.3%, 95% CI 31%-73%, P = 0.000004). HR was higher in SC arm compared to control at 6 weeks (89% vs 12%; difference 77%, 95% CI 49%-88%, p < 0.001) and 12 weeks (100% vs 59%; difference 41%, 95% CI 8%-64%, p = 0.0003). HP after 4 cycles was higher in patients receiving T versus those receiving A (77% vs 33%, p = 0.0307). Patient reported hair loss at primary endpoint evaluation landmark was significantly lower in SC versus control arm (45% vs 82%, p = 0.016) with compulsive head cover use of 47 % in SC vs 100% in controls (p = 0.0001). Of 33 patients who started on SC, 23(69%) patients experienced grade 1-2 cold related adverse effects in SC arm with no grade 3-4 events.

Conclusions

Women with breast cancer receiving A or T chemotherapy were significantly more likely to have <50% hair loss after chemotherapy, had superior hair regrowth and improved patient reported outcomes, if scalp cooling was used.

Clinical trial identification

CTRI/2017/02/007896.

Editorial acknowledgement

Legal entity responsible for the study

Jyoti Bajpai.

Funding

Orbis Paxman Hair Loss Prevention System.

Disclosure

J. Bajpai: Research grant / Funding (institution), No Personal Financial disclosures to declare: Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution), No Personal Financial disclosures to declare: Novartis; Research grant / Funding (institution), No Personal Financial disclosures to declare: Roche; Research grant / Funding (institution), No Personal Financial disclosures to declare: Samsung Bioepis Co. Ltd; Research grant / Funding (institution), No Personal Financial disclosures to declare: Sun Pharma; Leadership role, No Personal Financial disclosures to declare: Immuno-oncology Society of India(I-OSI); Leadership role, No Personal Financial disclosures to declare: Indian Society of Medical and Paediatric Oncology (ISMPO) ; Leadership role, No Personal Financial disclosures to declare: Indian cooperative Oncology network (ICON); Leadership role, No Personal Financial disclosures to declare: Teenage and Young Cancer Association (TYA). S. Gupta: Advisory / Consultancy, Research grant / Funding (institution), No Personal Financial disclosures to declare: Roche; Advisory / Consultancy, Research grant / Funding (institution), No Personal Financial disclosures to declare: Sanofi; Research grant / Funding (institution), No Personal Financial disclosures to declare: Johnson & Johnson; Research grant / Funding (institution), No Personal Financial disclosures to declare: Amgen; Research grant / Funding (institution), No Personal Financial disclosures to declare: Celltrion; Advisory / Consultancy, Research grant / Funding (institution), No Personal Financial disclosures to declare: Oncosten; Research grant / Funding (institution), No Personal Financial disclosures to declare: Novartis; Research grant / Funding (institution), No Personal Financial disclosures to declare: Intas; Research grant / Funding (institution), No Personal Financial disclosures to declare: Eisai; Research grant / Funding (institution), No Personal Financial disclosures to declare: Biocon; Advisory / Consultancy, No Personal Financial disclosures to declare: DRL; Advisory / Consultancy, No Personal Financial disclosures to declare: Biocon; Advisory / Consultancy, No Personal Financial disclosures to declare: Pfizer; Advisory / Consultancy, No Personal Financial disclosures to declare: Core diagnostics. All other authors have declared no conflicts of interest.