Clinical Trial to save hair during chemo

Hortense

For those concerned about losing their hair due to chemotherapy - and who have not yet started on their chemo regimen - I would like to let you know that there is a clinical trial going on right now to determine if scalp cooling using Dignicaps is effective at preserving hair during chemotherapy. It is open to people with stage 1 or 2 breast cancers and the Dignicap treatment would be free, so if you live anywhere near where the trials are taking place, you might look into them. I used Penguin Cold Caps in 2012 and was able to keep my hair, so I can vouch that scalp cooling does work. Dignicaps were not available back then, but I have been hearing good things about them in this trial - see CBS news story below.

- Information about Dignicaps:

http://www.medgadget.com/2013/06/dignicap-to-help-...

- Plus a recent CBS TV News story about them:

http://losangeles.cbslocal.com/2014/03/18/ucla-tes...

- for more information about scalp cooling go to: 

www.rapunzelproject.org

- and to the "Cold Cap Users Past and Present, to save hair" thread on this website, found under All Topics - Help Me Get Through Treatment - Cold Cap Users:

- Below is the official government webpage with information about the Dignicap Trials and where to contact the hospitals and doctors involved:

http://clinicaltrials.gov/ct2/show/NCT01831024

There are two locations in New York City, one in San Francisco and one in Winston-Salem, NC. The cost of using the Dignicaps as part of the trial is nothing. It is hoping to enroll 110 people by September 2014.

United States, CaliforniaSan Francisco, California, United States, 94115Contact: Hope S. Rugo, MD 415-353-7428 hrugo@medicine.ucsf.edu Principal Investigator: Hope S. Rugo, MD United States, New YorkNew York, New York, United States, 10065Contact: Tessa Cigler, MD 617-821-0726 tec9002@med.cornell.edu Principal Investigator: Tessa Cigler, MD New York, New York, United States, 10011Contact: Margarita Gilyadova, MD 212-367-0181 mgilyado@chpnet.org Principal Investigator: Paula Klein, MD United States, North CarolinaWinston-Salem, North Carolina, United States, 27157Contact: Susan A. Melin, MD 336-716-2839 smelin@wakehealth.edu Principal Investigator: Susan A. Melin, MD

Eligibility

Ages Eligible for Study: 18 Years and olderGenders Eligible for Study: FemaleAccepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Female patients >/= 18 years of age
• Documented diagnosis of stage I or II breast cancer
• A planned course of chemotherapy in the adjuvant or neoadjuvant setting with curative intent including one of the following regimens:
  • Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 2 - 3 weeks
  • Docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 3 weeks
  • Paclitaxel 80 mg/m2 weekly IV x at least 12 weeks with or without IV trastuzumab
  • Paclitaxel 175 mg/m2 IV every 2 weeks x 4 - 6 cycles (without an anthracycline)
  • Paclitaxel weekly and carboplatin AUC 2 weekly or AUC 6 every 3 weeks IV x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks
  • Docetaxel 75 mg/m2 and carboplatin AUC 6 IV every 3 weeks x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks
  • Targeted agents such as trastuzumab or lapatinib are allowed
• Plan to complete chemotherapy within 6 months
• At least two years out from the last chemotherapy causing hair loss with complete recovery of hair
• Karnofsky performance status >/= 80%
• Willing and able to sign informed consent for protocol treatment
• Willing to participate in study procedures including having photographs of the head before the first cycle of chemotherapy and 1 month after the last chemotherapy
• Willing to enroll in an extension protocol for follow up for 5 years following the end of chemotherapy treatment

Exclusion Criteria:

• Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
• Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
• A history of whole brain radiation
• Plans to use a chemotherapy regimen other than those specified in the inclusion criteria. Specifically, patients receiving a regimen including both an anthracycline and a taxane are not eligible for this trial (AC/T, EC/T, TAC, etc.)
• Concurrent hormone therapy with chemotherapy. Hormone therapy should be used as indicated following completion of chemotherapy
• Underlying clinically significant liver disease including active viral hepatitis with abnormal liver function tests >1.5 times the upper limit of normal, including alkaline phosphatase, AST, and total bilirubin. Patients with Gilbert´s disease (elevated indirect bilirubin only) will be eligible for participation.
• Clinically significant renal dysfunction defined as serum creatinine > upper limit of normal.
• A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
• A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
• Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause hair loss
• Intercurrent life-threatening malignancy
• A history of cold agglutinin disease or cryoglobulinemia.
• Evidence of untreated or poorly controlled hyper or hypothyroidism
• A history of silicon allergy
• American Society of Anesthesiologist Class ≥3

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