Pediatric patients should not use DigniCap.
Adult patients with the following conditions and cancer types should not use DigniCap:
- Cold sensitivity
- Cold agglutinin disease
- 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
- Patient who have had previous chemotherapy
- Patients who are scheduled for bone marrow ablation chemotherapy
- Patients who are scheduled to undergo skull irradiation
- Patients who have previously received skull irradiation
Scalp cooling is contraindicated if chemotherapy with a curative intent is given in patients with hematological malignancies or with solid tumor malignancies with a high likelihood of metastases in transit.
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 (administered same day) has not been shown to be successful in preventing chemotherapeutic drug induced alopecia. DigniCap 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.