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 on the same infusion day has not been shown to be successful in preventing chemotherapeutic drug induced alopecia. The 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.

There is a potential for cold injury, even when providing cooling within the prescribed treatment settings. Special care should be taken when applying the Cooling Wrap to ensure that there is no direct contact between a patient’s exposed skin and the wrap’s cooling surface. Individuals who experience any unusual swelling, skin discoloration or discomfort should immediately discontinue the use of the DigniCap System.