Chemotherapy May Destroy Your Patients’ Cancer, But It Doesn’t Have to Destroy Their Hair

Why Hair Loss Matters to Your Patients

Treating your patient’s cancer is your top priority. For many cancer patients, however, chemotherapy-induced alopecia (CIA) is more than a matter of vanity. It can become a continual, unwelcome reminder of the disease and treatment, one that can negatively affect a patient’s self-image, confidence, and sense of well being. Concern about CIA can influence attitude and behavior in ways that may even interfere with compliance with treatment at a time when they can least afford it.

In a recent nationwide survey of 400 women, 9 out of 10 who were informed about scalp cooling showed a high level of interest, and 8 out of 10 of those surveyed said availability of a scalp cooling system would significantly influence their choice of an infusion center.

DigniCap® – The Intelligent Scalp Cooling System™

The U.S. pivotal study has provided strong evidence that scalp cooling can be a safe and effective treatment to help mitigate CIA among chemo patients. However, until now, no scalp cooling system has received U.S. FDA clearance, so infusion centers were precluded from getting involved in providing the service directly to patients. With the FDA clearance of the DigniCap® system, that has now changed.

The DigniCap® scalp cooling system completed an FDA approved multi-center clinical trial and received cearance for use by women who are diagnosed with breast cancer.

The trial results demonstrated that the DigniCap® scalp cooling system is safe and effective for breast cancer patients undergoing many common chemotherapy regimes.  Infusion centers will now be able to install DigniCap® systems on site and offer the treatment directly to patients as an adjunct to their infusion treatment.

Learn more about offering DigniCap® system treatments to your patients

About the DigniCap® System

The DigniCap® system consists of a snug-fitting silicone cooling cap connected to a computer-operated cooling and control unit. Coolant continuously circulates through channels in the cap, cooling the scalp during chemotherapy. A sophisticated system of sensors ensures that optimal temperature is continuously maintained throughout treatment. Lower scalp temperature in turn helps protect hair follicles from the damaging effects of chemo by reducing blood flow and cell metabolism.

  • The DigniCap® system is the first scalp cooling system to achieve U.S. FDA clearance
  • Major advancement in comfort and convenience compared with non-FDA cleared manual cold caps (compare DigniCap® with manual cold caps)
  • Used successfully by thousands of patients around the world for more than a decade

Click here for more detailed information about scalp cooling and DigniCap®.

Learn more about offering DigniCap® system treatments to your patients.

 

Clinical Considerations

Indication for use

The DigniCap® scalp cooling system is indicated to reduce the likelihood of chemotherapy-induced alopecia in women with breast cancer.

Intended Use

A cooling device intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia inducing chemotherapy agents are used.

Contraindications

Contraindications include cold sensitivity, cold agglutinin disease, cryoglobulinemia and cryofibrinogenemia.

Scalp cooling is contraindicated in patients with hematological malignancies, if chemotherapy is given with a curative intent.

 

Adverse events

Most patients tolerate scalp cooling with DigniCap® scalp cooling system very well. In the clinical study conducted in the U.S. for FDA clearance, three of 101 patients discontinued scalp cooling because of intolerance to the cooling.

Approximately half of the patients experienced a mild to moderate headache that was triggered or exacerbated by scalp cooling using DigniCap® scalp cooling system.

Mild scalp pain was experienced by the majority of the patients, but rarely required pain medications to control the pain.

 

Long term adverse events

When using scalp cooling, less chemotherapy is distributed to the hair cells, and cancer cells could theoretically survive locally within the scalp area. In breast cancer patients there has been a concern for scalp and skin metastases when scalp cooling patients. Based on medical literature, scalp and skin metastases are rare occurrences regardless of breast cancer stage (scalp metastases as first sign of recurrence occurs in 1 out of 4,000 patients, and in 1 out of 100 patients who already have other sites of metastasis). The observed risk of scalp metastasis does not seem to differ between patients who have and have not used scalp cooling.

 

Information for
Patients

Learn about reducing hair loss for yourself or a loved one. Hear patients tell their stories about scalp cooling.

Find out when the DigniCap® scalp cooling system will be available near you.

 

 

 

 

Information for
Healthcare Professionals

Find out how scalp cooling can help your patients. Read about the science behind scalp cooling and clinical research findings on safety and efficacy.

 

Learn about
Availability

Find out where the DigniCap® scalp cooling system is currently available.