Clinical Information

Why Hair Loss Matters to Your Patients

Treating your patient’s cancer is your top priority. For many cancer patients, however, chemotherapy-induced alopecia 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 alopecia 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 alopecia among chemo patients.  With the FDA clearance of The DigniCap® system, infusion centers may now provide this much-needed service to patients.

The DigniCap® Scalp Cooling System completed a rigorous multi-center clinical trial  to receive FDA clearance and is indicated to reduce the liklihood of chemotherapy-induced alopecia in cancer patients with solid tumors.

The trial results demonstrated that The DigniCap® scalp cooling system is safe and effective for 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® Scalp Cooling 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 was the first scalp cooling system to achieve U.S. FDA clearance
  • Major advancement in comfort and convenience compared to 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 cancer patients with solid tumors.

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

The use of DigniCap is contraindicated in pediatric patients.

The use of DigniCap is contraindicated in adult patients with:
• Cold sensitivity
• Cold agglutinin disease
• Cryoglobulinemia
• Cryofibrinogenemia
• Cold urticaria
• CNS malignancies (either primary or metastatic)
• Squamous cell carcinoma of the lung
• Small cell carcinoma of the lung
• Cancers of the head and neck
• Skin cancers including melanoma, squamous cell carcinoma, and Merkel cell
carcinoma
• Hematological malignancies treated with curative intent by chemotherapy
• Solid tumor malignancies with a high likelihood of metastases in transit
• Patients who are scheduled for bone marrow ablation chemotherapy
• Patients who are scheduled to undergo skull irradiation
• Patients who have previously received skull irradiation

Warnings
Scalp and/or cutaneous metastases have been reported in patients with non-small cell lung cancer, colon cancer, renal cell carcinoma, ovarian cancer, and bladder cancer. Patients with advanced forms of these cancers may be more likely to experience scalp metastases with the scalp cooling system.

Use of Scalp Cooling in the palliative setting in patients with metastatic cancer may also increase the risk for scalp metastases.

Use of scalp cooling with taxanes plus anthracyclines when used in combination has not been
shown to be successful in preventing chemotherapeutic drug induced alopecia. DigniCap® Scalp Cooling System should not be used in these patients.

Scalp radiation can cause stenosis of small cutaneous vessels decreasing device effectiveness.
The effectiveness of this device in patients who have received previous chemotherapy has not
been evaluated.
The risk of scalp-cooling may outweigh the benefits in patients receiving chemotherapeutic
agents with low incidence of inducing alopecia.
Long-term effects of scalp-cooling and risk of scalp metastasis have not been fully studied.
Clinical studies have demonstrated variable success rates in patient reduction of chemotherapy-induced alopecia with scalp cooling since the outcome is dependent on multiple factors including chemotherapy regimen, dose, duration of drug infusion, chemotherapy drug metabolism, and concomitant comorbidities. Data have shown that women who experience hair loss in spite of using scalp cooling might have worse quality of life than women who did not have scalp cooling.

 

Adverse events

Most patients tolerate scalp cooling with The 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 The 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 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 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  where DigniCap® is 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.