DigniCap:
FDA approved device to prevent alopecia from chemotherapy
Who - Why - How
Hair loss is not only the most visible side effect from chemotherapy, but it is often reported as the most traumatic and is cited as a reason some patients forgo treatment.
As the study coordinator, I identified eligible patients for the feasibility and efficacy trial, as well as operated study device, monitored study patients, collected, analyzed, and reported clinical research data.
actively managed patients on the pilot study (including device operations and data collection), organized and educated the FDA-mandated Independent Panel for scoring of blinded data, compiled the pilot study data for the FDA Report, and consulted Dignitana on how to improve the device and trial logistics for the pivotal study. I also presented posters at multiple national oncology scientific conferences, and coordinated with the AP Press and other media outlets covering the trial progress.
July 2017
FDA approves DigniCap for use any kind of solid tumor
In the first year of FDA approval, Dignitana signed contracts with 52 hospitals in 17 states to be able to offer the DigniCap device to patients in their infusion centers.* While de-novo FDA approval in 2015 was specifically for patients with breast cancer, the FDA's approval for all solid tumors enables patients with tumors of the brain, ovary, breast, colon and other tissues to also prevent hair loss during chemotherapy.
* Dignitana press release December 8, 2016
February 2017
JAMA features scalp cooling studies
Dr. Hope Rugo, the Principal Investigator of the pilot and pivotal Dignitana studies, and my mentor at UCSF, is the primary author of an article featured in JAMA: Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer.
Additionally, The New York Times published an article: Scalp Cooling Helps Prevent Hair Loss in Chemo. This is a wonderful sign of education and acceptance of scalp-cooling treatment amongst oncologists and medical practitioners. The article references our work together.
December 2012
Results presented at the San Antonio Breast Cancer Symposium 2012
Use of the DigniCap™ System to Prevent Hair Loss in Women Receiving Chemotherapy (CTX) for Stage I Breast Cancer (BC)
I created and presented our poster at the 2012 San Antonio Breast Cancer Symposium. Our results to date showed the the DigniCap System was feasible and effective at preventing hair loss for women undergoing treatment for stage I breast cancer. With a median follow-up of 15.4 months, we were also able to include results from the Independent Panel.
Rugo HS, Serrurier KM, Melisko A, et al. Use of the DigniCap™ system to prevent hair loss in women receiving chemotherapy (CTX) for stage I breast cancer (BC) Cancer Res. 2012;72(24 suppl):A2.
May 2012
Dignitana Pilot Study Report submitted to FDA
This report compiled the data collected to assess the feasibility of use of the DigniCap™ System. I compiled the data presented in the report, which included:
- Safety and tolerability reported by patients
- Hair loss reported by clinical providers
- Hair loss scored by an Independent Panel based on photographic evidence
The integrity and validity of the report, coupled with the data results, successfully met the FDA's requirements, leading to a breakthrough approval pivotal trial for FDA market approval.
Download JAMA article Rugo HS et al., here: