Location: the United States of America

Can I scalp cool?

Many patients ask - can I scalp cool? Scalp cooling can be used by adult cancer patients receiving chemotherapy to treat solid tumor cancers such as, but not limited to, breast, ovarian, other gynecologic, lung and prostate cancers.

Can I scalp cool?

Scalp cooling can be used by adult cancer patients receiving chemotherapy to treat solid tumor cancers such as, but not limited to, breast, ovarian, other gynecologic, lung and prostate cancers.

There is no evidence to show that scalp cooling is more or less effective for different genders, ethnicities or with different hair types.
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As the manufacturer of a medical device, we are required to provide you with the following information. It has been written in a way that meets regulation, but it isn’t always the easiest to understand. If you have question on any of the information that you find below, speak with your clinical team for guidance.
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Indications for use

An indication for use describes the circumstances or conditions in which a medical device will be used. Essentially, the reason why you would use the device.

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Who should use the Paxman Scalp Cooling System?

The Paxman Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumors.

Intended use

The Paxman Scalp Cooling System is intended for use by appropriately qualified healthcare professionals who have been trained in correct operation of the device by a Paxman representative.

You should be aware of the following:

  • Hair loss is a possible side effect of chemotherapy
  • The treatment success rates with the Paxman Scalp Cooling System vary from patient to patient and with different drug regimens being administered
  • Patients cannot be guaranteed they will not lose any or all of their hair
  • Some patients may feel cold during treatment
  • Some patients may feel lightheaded after the Paxman Scalp Cooling Cap has been removed
  • Patients may visit the restroom during treatment

Contraindications

Contraindications describe circumstances or conditions in which a medical device, drug or treatment should not be used.

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Scalp cooling is contraindicated in pediatric patients.
Scalp cooling is also contraindicated in patients with:

  • An existing history of scalp metastases or the presence of scalp metastasis is suspected
  • Cancers of the head and neck
  • CNS malignancies (either primary or metastatic)
  • Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, and post-traumatic cold dystrophy
  • Hematological malignancies (leukemia, nonHodgkin and other generalized lymphomas) or hematological malignancies that are being treated for cure.
  • Imminent bone marrow ablation chemotherapy
  • Imminent skull irradiation.
  • Previously received, or scheduled to undergo skull irradiation
  • Scalp metastases have rarely been reported in the literature, but caution regarding their development has been a limitation for the broad-scale application of scalp cooling during chemotherapy
  • Theoretically, tumor cells that have seeded in the scalp might not receive adequate chemotherapy during hypothermia, thus allowing them to grow at a later date
  • Severe liver or renal disease from any etiology who may not be able to metabolize or clear the metabolites of the chemotherapeutic agent
  • Skin cancers including melanoma, squamous cell carcinoma, and Merkel cell carcinoma
  • Small cell carcinoma of the lung
  • Solid tumors that have a high likelihood for metastasis in transit
  • Squamous cell carcinoma of the lung

Side effects

A side effect is a secondary or unintended effect of a drug or medical treatment, which are often undesirable.

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Known side effects associated with scalp cooling include:

  • Chills
  • Dizziness
  • Headache
  • Nausea
  • Paresthesia (an abnormal sensation such as tingling, tickling, pricking, numbness, or burning of the skin–a “pins and needles” feeling)
  • Pruritus (severe itching)
  • Sinus pain
  • Skin tissue disorders
  • Skin ulceration
All of these side effects occur during the scalp cooling process. They are transient or temporary in duration, and are generally recognized as presenting a low risk of harm (although in some cases, patients have discontinued scalp cooling because of these effects).

Safety

The following information outlines research showing that scalp cooling is a safe treatment.

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The following information outlines research showing that scalp cooling is a safe treatment.

The only known potential long-term side effect of scalp cooling is also the most controversial one; this is that scalp cooling when used on women receiving chemotherapy for breast cancer could lead to an increased incidence of scalp metastases. (This is because the same mechanisms that restricts the effectiveness of the chemotherapeutic agent against hair roots or follicle cells in the scalp can also restrict the effectiveness of the chemotherapeutic agent against cancerous tissue in the scalp.)

The natural incidence of scalp metastases in patients with breast cancer is approximately 1 in 4000. This incidence seems to be about the same in patients who receive scalp cooling and those who don’t.

There is no clinical evidence that cooling the scalp during adjuvant and palliative chemotherapy treatment increases the risk of developing scalp metastases. The issue remains a theory or possibility, but it has not been proven. The Paxman Scalp Cooling System is the leading product found to minimize the risk of hair loss during chemotherapy in women with breast cancer. Your healthcare professionals can advise you if scalp cooling is likely to be successful with your chemotherapy treatment, or whether any other treatments, or the use of a wig, scarf, or headcover, may be more appropriate.



Scalp cooling has also been proven to have no negative effect on survival rates. click here.

Being able to maintain that sense of normalcy during such a traumatic time was invaluable.

Paige
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