Safety Considerations

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Clinical studies have successfully demonstrated the effectiveness of the Paxman Scalp Cooling System in the prevention of chemotherapy-induced alopecia, or hair loss, with widely used chemotherapy dosages and regimens for breast cancer.

Hair retention rates are variable, however, since successful scalp cooling depends on many factors such as the chemotherapy regimen and dose, duration of drug infusion, metabolism of the chemotherapy drug, and concomitant comorbidities or other conditions. Age, hair type, hair condition, and general health can also affect the results of the Paxman Scalp Cooling System. It cannot be guaranteed that scalp cooling will prevent all patients undergoing chemotherapy from losing any or all of their hair. The success rates of scalp cooling in reducing chemotherapy induced alopecia, or hair loss, vary from patient to patient and depend on the chemotherapy regimen administered.

Research has shown that scalp cooling is very effective across a wide range of chemotherapy regimens. You may experience some hair loss and overall thinning of the hair while using scalp cooling, and the normal shedding cycle of the hair will continue. We encourage you to continue scalp cooling even if you experience some hair loss, Many women report hair growth during their chemotherapy treatment while using scalp cooling, as new hair growth is also protected from the chemotherapy drugs.

Based on recent research, women are advised not to buy a wig during scalp cooling. The study suggests that women should wait until a wig becomes necessary. This study was authored by Dr van den Hurk and others and is available here.

Your healthcare professionals and medical team will let you know if scalp cooling is likely to be successful with your chemotherapy treatment.

Research has shown that scalp cooling is very effective across a wide range of chemotherapy regimens.

Will Scalp Cooling work?

Many thousands of men and women throughout the world have retained their hair using the Paxman Scalp Cooling System while receiving chemotherapy treatment.

Indication for use

Who should use the Paxman Scalp Cooling System?

The Paxman Scalp Cooler 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

  • Patients may have a headache during treatment

  • 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

Scalp cooling is contraindicated in pediatric patients. Scalp cooling is 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, non-Hodgkin 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

Warnings and Precautions

  • 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 tumors may be more likely to experience scalp metastases with the scalp cooling system

  • It cannot be guaranteed that scalp cooling will prevent all patients undergoing chemotherapy from losing any or all their hair. The success rate of scalp cooling in reducing chemotherapy-induced hair loss varies from patient to patient and according to the chemotherapy regimen administered

  • Long-term effects of scalp-cooling and scalp metastasis have not been thoroughly studied

  • 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 together or in sequence has not been shown to be successful in preventing chemotherapeutic drug induced alopecia.  The Paxman Scalp Cooler should not be used in these patients

  • The effectiveness of this device in patients who have received previous chemotherapy has not been evaluated.

  • 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 despite using scalp cooling might have worse quality of life than women who did not have scalp cooling.

  • The Paxman Scalp Cooler should only be used by appropriately qualified healthcare professionals who have been trained in the operation of the device.

  • Do not allow any liquids to be placed on the scalp cooler or near the touch screen controller, including drips from the cooling caps

  • Avoid use in ambient temperatures of over 30°C/86°F

  • Do not touch the side ventilation grills whilst the device is in use

Attention:

Clinical studies have successfully demonstrated the effectiveness of the Paxman Scalp Cooling System in the prevention of chemotherapy-induced alopecia, or hair loss, with widely used chemotherapy dosages and regimens for solid tumor cancers. Hair retention rates are variable, however, since successful scalp cooling depends on many factors such as the chemotherapy regimen and dose, duration of drug infusion, metabolism of the chemotherapy drug, and concomitant comorbidities or other conditions. Age, hair type, hair condition, and general health can also affect the results of the Paxman Scalp Cooling System.

It cannot be guaranteed that scalp cooling will prevent all patients undergoing chemotherapy from losing any or all of their hair. The success rates of scalp cooling in reducing chemotherapy- induced alopecia, or hair loss, vary from patient to patient and depend on the chemotherapy regimen administered.

Research has shown that scalp cooling is very effective across a wide range of chemotherapy regimens. You may experience some hair loss and overall thinning of the hair while using scalp cooling, and the normal shedding cycle of the hair will continue. We encourage you to continue scalp cooling even if you experience some hair loss, Many people report hair growth during their chemotherapy treatment while using scalp cooling, as new hair growth is also protected from the chemotherapy drugs.

Based on recent research, it is advised not to buy a wig during scalp cooling. The study suggests that you should wait until a wig becomes necessary. This study was authored by Dr van den Hurk and others and is available at here.

(van den Hurk CJ, van den Akker-van Marle ME, Breed WP, van de Poll-Franse LV, Nortier JW, Coebergh JW. Impact of scalp cooling on chemotherapy-induced alopecia, wig use and hair growth of patients with cancer. Eur J Oncol Nurs. 2013;17(5):536-540.)

Your healthcare professionals and medical team will let you know if scalp cooling is likely to be successful with your chemotherapy treatment.

Hair loss is very common during chemotherapy for breast cancer as well as other cancers, though some drugs and methods of administration are more likely than others to disrupt hair follicles.

Chemotherapy-induced hair loss is a common and distressing side effect of cancer therapy and is one of the major unmet challenges in cancer management. Scalp cooling can prevent chemotherapy-induced hair loss in some cancer patients with solid tumors receiving certain chemotherapy regimens. Recent evidence indicates that this technique does not increase the risk of scalp metastasis. A reduction in post-chemotherapy infusion duration of scalp cooling and the advancement in cool cap technology may assist clinicians in promoting scalp cooling to cancer patients / to improve the patient experience of chemotherapy-induced hair loss.

Alopecia is a common side effect of chemotherapies used in the treatment of cancer. The effects of alopecia on quality of life (QOL) on various aspects of QOL in cancer patients includes anxiety and distress, body image, sexuality, self-esteem, social functioning, global QOL and return to work outcomes.

Hair loss consistently ranked amongst the most troublesome side effects, and is described as distressing, and may affect the body image. The presence and extent of negative effects on chemotherapy-induced alopecia on various aspects of QOL of patients who have had scalp cooling may be worse than those who did not have scalp cooling.

Whether a patient develops hair loss and the degree of hair loss depends on several factors including:

  Dose of chemotherapy

  How often the chemotherapy is given

  The route of administration

  The drugs or combination of drugs received

Chemotherapy-induced hair loss is almost always reversible.

Hair loss often begins around the time of the second chemotherapy infusion, though this varies widely. Some people do not lose all of their hair until they have nearly completed chemotherapy.

Data have shown that women who experience hair loss despite using scalp cooling might have worse quality of life than women who did not have scalp cooling. It is important to select those patients who would benefit most from scalp cooling.2/3   

The following table identifies the chemotherapeutics cited as most likely to cause chemotherapy induced alopecia. The risk of scalp cooling may outweigh the benefits in patients receiving chemotherapeutic agents with a high incidence of inducing alopecia.

1Lemieus J, Maunsell E, Provencher L. Chemotherapy-induced alopecia and effects on quality of life among women with breast cancer: a literature review. Psycho-Oncology 17:317–328 (2008).

2 Udrea, A. Scalp cooling system in preventing chemotherapy-induced alopecia: a pilot study on 108 patients –a Romanian oncology –day hospital experience. Medisprof Oncology. Psycho-Oncology 23 (Suppl. 3):169-254 (2014), P1-0062.

3Van der Hurk CJ, Mols F. Impact of alopecia and scalp cooling on the well-being of breast cancer patients. Psycho-Oncology. 19(7):701-9 (2010).

Chemotherapy Drugs Most Likely to Cause Hair Loss1

Dunnill CJ, Al-Tameemi W, Collett A, Haslam IS, Georgopoulos NT. A Clinical and Biological Guide for Understanding Chemotherapy-Induced Alopecia and Its Prevention. Oncologist. 23(1):84-96 (2018).

Patients treated with certain chemotherapeutic agents, including AC, DAC and Irini mono, as well as patients with Asian or chemically-colored hair may be least likely to benefit from scalp cooling. The risk of scalp cooling may outweigh the benefits in patients that are least likely to benefit from scalp cooling.

Adverse Effects

Known side effects associated with scalp-cooling therapy 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).

The majority of women using the Paxman Scalp Cooling System reported being able to tolerate a high level of cooling. They also reported a high level of comfort and acceptability. Few people discontinued scalp cooling because of side effects. Most patients were comfortable, reasonably comfortable, or very comfortable while wearing the device; many said they were reasonably comfortable. In the multicenter, randomized clinical trial that Paxman conducted in the United States for FDA clearance, only 6 participants of 142 patients discontinued scalp cooling because of intolerance.

Data have shown that women who experience hair loss despite using scalp cooling might have worse quality of life than women who did not have scalp cooling. It is important to select those patients who would benefit most from scalp cooling.1 2

1. Udrea, A. Scalp cooling system in preventing chemotherapy-induced alopecia: a pilot study on 108 patients – a Romanian oncology – day hospital experience. Medisprof Oncology. Psycho-Oncology 23 (Suppl. 3):169-254 (2014), P1-0062.

2. Van der Hurk CJ, Mols F. Impact of alopecia and scalp cooling on the well-being of breast cancer patients.
Psycho-Oncology. 19(7):701-9 (2010).

A Potential Long-Term Side Effect

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 restrict 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.