FREQUENTLY ASKED QUESTIONS

Sections:

  1. Scalp Cooling Overview
  2. Hair Loss and Effectiveness
  3. Paying for Treatments
  4. Hair Care
  5. Contraindications
  1. SCALP COOLING OVERVIEW

What is scalp cooling?

Scalp cooling is a proven approach to reduce chemotherapy-induced alopecia that has been used successfully by thousands of patients worldwide for several decades. Reduced temperature results in a decreased blood flow to the scalp area so that less chemotherapy reaches the hair cells. Hair cells are therefore not exposed to the full dose of chemotherapy and may be able to survive the chemotherapy treatment. As a result, hair is less likely to fall out.


How does scalp cooling work?

When a patient’s scalp is cooled, two physiologic reactions occur:

1. Reduced blood flow–vasoconstriction in the localized scalp area limits the amount of chemotherapy agent delivered to the scalp and hair follicles.

2. Reduced reaction rate – the lower scalp temperature decreases metabolism causing normal cellular activity in the localized scalp area to slow dramatically. Fewer chemotherapy agents are then absorbed by the hair cells and damage is significantly reduced.


Why does chemotherapy cause hair loss?

Chemotherapy affects cells that are in the phase of division or growth. All the cells in the body may be affected by chemotherapy, not just the cancer cells. This means that even healthy cells, especially cells with a high growth rate such as your hair, are likely to be affected by the chemotherapy.


Has The DigniCap Scalp Cooling System received FDA clearance?

Yes. On December 8, 2018 DigniCap became the first scalp cooling system to be cleared by the FDA to treat chemotherapy-induced hair loss for breast cancer patients. On July 3, 2017, the FDA granted DigniCap expanded clearance to treat men and women with solid tumor cancers, such as those associated with breast, prostate, ovarian, uterine, lung and other tissues.


How is DigniCap different from other scalp cooling treatments?

On December 8, 2018 DigniCap became the first scalp cooling system to be cleared by the FDA to treat chemotherapy-induced hair loss for breast cancer patients. On July 3, 2017, the FDA granted DigniCap expanded clearance to treat men and women with solid tumor cancers, such as those associated with breast, prostate, ovarian, uterine, lung and other tissues.

DigniCap incorporates a number of patented features and technological advances that combine to improve the patient experience. The cooling cap has two dedicated temperature regulation sensors in each cap that monitor scalp temperature, and a third safety sensor to ensure that the scalp temperature never falls below freezing.

Unlike manual cooling caps, DigniCap’s cooling cap is fitted once at the beginning of treatment and remains on until completion. For a detailed comparison of DigniCap and manual scalp cooling approaches CLICK HERE.


When would I use DigniCap?

The DigniCap Scalp Cooling System is used during each cycle of chemotherapy administration. Scalp cooling should begin with the first infusion of any chemotherapy that causes hair loss.


Is scalp cooling right for me?

Please read the following statements to determine if scalp cooling is a good option for you.

  1. I understand that the experience may involve pain or discomfort with cold, which typically diminishes within the first 30 minutes of treatment.
  2. I understand there are special hair care recommendations during treatment.
  3. I understand that scheduling of treatment will depend on the availability of a DigniCap machine and that I will need to have a cap fitting done prior to the first visit.
  4. I understand that if I use this service there will be extra time (90-180 minutes) needed for my treatment chair time.
  5. I understand that the goal of treatment with DigniCap is 50% hair loss or less. I am aware that shedding will occur and that the use of DigniCap will not completely prevent hair loss. Hair loss is variable from patient to patient.
  6. I understand that insurance may not cover the cost of DigniCap treatments.
  7. I have discussed the contraindications and warnings with the use of DigniCap with the provider and understand and agree to accept these risks.

How does scalp cooling feel?

Most patients tolerate scalp cooling with The DigniCap Scalp Cooling System very well. The system cools the cap down gradually from room temperature, and the cap temperature never drops below freezing to help make the treatment more comfortable for patients. Common side effects include a feeling of coldness, headache, scalp pain and/or light-headedness. Your doctor can provide a pain reliever if you develop a headache. A warm drink or blanket may help if you are feeling cold.


How long does scalp cooling treatment take?

The scalp cooling device is operated by trained clinical staff and will be used during each chemotherapy session. Scalp cooling begins approximately 30 minutes before chemotherapy starts (while pre-meds are administered), continues during the infusion of hair loss causing chemo agents, and then continues for a set period of time after depending on the chemotherapy drug and dose. Patients will need to maintain a reduced scalp temperature for 90-180 minutes following the completion of their chemotherapy infusion. After completion of the post-infusion cooling time, the cooling cap remains on your scalp for another 5-10 minutes to allow the scalp temperature to slowly increase and diminish any discomfort.


What should I bring with me to the infusion center on the day of the scalp cooling treatment?

Your clinician can best tell you what you should bring on the day of the treatment. It’s generally recommended that you wash your hair on the morning of treatment (without applying conditioner). You may wish to come with your hair wet, combed out, and parted down the middle as that will speed up the process of putting on your cap. You may also wish to bring your own warm blanket, socks, sweater, a neck pillow, etc. Some patients bring their own towel to use while wetting their hair.


2. HAIR LOSS & EFFECTIVENESS

Will I lose some hair during scalp cooling?

Yes. DigniCap offers patients the ability to reduce hair loss from chemotherapy. However, most patients will still lose some hair. DigniCap’s multi-center clinical trial resulted in 66.3% of patients keeping at least 50% of their hair. The hair shedding process usually beings 14-21 days from your first chemotherapy infusion. Depending on your regimen, it is usually around the second treatment. If you are on a weekly dose, shedding typically begins after the 4th treatment. Effectiveness of scalp cooling treatments is dependent on several factors including chemotherapy regimen, dose, duration of drug infusion, chemotherapy drug metabolism, and concomitant comorbidities.


How effective is scalp cooling?

The DigniCap’s multi-center clinical trial resulted in 66.3% of patients keeping at least 50% of their hair.


Will scalp cooling prevent hair loss on my eyebrows and eyelashes?

No. DigniCap prevents hair loss on the scalp area where cooling is applied and therefore does not prevent eyebrow or eyelashes from thinning.


Will scalp cooling work for my cancer?

Scalp cooling is a proven approach to reduce chemotherapy-induced alopecia that has been used successfully by thousands of patients worldwide with a variety of cancers and chemotherapy regimens. Dignitana´s multi-site scalp cooling study proved that scalp cooling is a safe and effective method for reducing the risk of chemotherapy-induced hair loss in women with breast cancer. However, almost everyone can expect to experience some degree of hair loss during chemotherapy.

Patients receiving chemotherapy regimens that are unlikely to produce significant alopecia are unlikely to experience benefit warranting possible risk of scalp metastases or long-term changes in cancer prognosis. Patients receiving chemotherapy regimens that can cause significant alopecia are also unlikely to see benefit of the cooling cap. The outcome is dependent on several factors including the chemotherapy regimen, dose, duration of drug infusion, chemotherapy drug metabolism and concomitant comorbidities.

The DigniCap Scalp Cooling System received FDA clearance in December 2015 to reduce the likelihood of chemotherapy-induced alopecia in women with breast cancer. In 2017, Dignitana received an expanded clearance from the FDA, allowing DigniCap to be used by patients receiving chemotherapy to treat solid tumors from breast cancer as well as those from prostate, ovarian, uterus, lungs and other tissues.

Please see the list of contraindications HERE.


Will scalp cooling work for my chemo regimen?

Scalp cooling has been evaluated mainly with regimens including anthracyclines (such as doxorubicin and epirubicin) and taxanes (such as paclitaxel and docetaxel). It’s not always possible to know how effective the scalp cooling outcome will be until you try it. The effectiveness of scalp cooling with chemotherapy regimens that include sequential anthracycline and taxane chemotherapy (administered same day) has not been well studied. Your clinician can tell you if scalp cooling is compatible and/or successful with your treatment.

Some of the typical chemo regimens that use scalp cooling are:

  • Paclitaxel (weekly and biweekly)
  • Paclitaxel + Carboplatin (every 3 weeks)
  • Docetaxel/ Cyclophosphamide
  • Docetaxel/ Carboplatin
  • Docetaxel/ Carboplatin/ Herceptin
  • Docetaxel/ Carboplatin/ Herceptin/ Perjeta
  • Docetaxel/ Cyclophosphamide/ Herceptin
  • Docetaxel mono-therapy (every 3 weeks)
  • Doxorubicin/ Cyclophosphamide
  • Abraxane
  • Cytoxan/ Methotrexate/ 5-FU
  • Eribulin
  • Other Taxane-based regimens
  • Other anthracycline-based regimens

Does scalp cooling increase the risk of scalp metastases?

No. Scalp metastases are the development of secondary malignancy at a site away from the primary cancer growth. Scalp cooling does not increase this risk, as shown in a 2017 study published in Breast Cancer Research and Treatment. The incidence of scalp metastases was low regardless of scalp cooling. This analysis suggests that scalp cooling does not increase the incidence of scalp metastases.

More information on scalp metastases can be found HERE.


3. PAYING FOR TREATMENTS

Will insurance cover DigniCap treatments?

Insurance coverage for scalp cooling is not yet standard in the United States, however DigniCap patients have submitted insurance claims and received reimbursement for treatment costs at varying levels since DigniCap received FDA clearance in 2015. Success with reimbursement varies depending on plan, coverage, and location. With the July 2017 FDA expansion of DigniCap clinical indications to include patients with solid tumors, claims for reimbursement and demand for coverage will continue to build as more patients utilize scalp cooling at infusion centers across the United States.

Here are suggestions for your insurance reimbursement submission:

  1. Obtain a blank claim form from your insurer.
  2. ICD codes on your claim form need to match your diagnosis exactly. These will likely be in the range of:

      0–C96.9 (Malignant neoplasm)

  1. Suggested ICD diagnosis codes are:

      Z51.11 (Antineoplastic chemotherapy)
      L65.9 (Nonscarring hair loss unspecified, chemotherapy induced alopecia)

  1. You may need to provide a CPT procedure or service code. There is not a unique CPT code for scalp cooling.  Suggested CPT codes are:

      97039 (Constant attendance)
      A9273 (Ice cap, cold wrap or pack)
      A9282 (Wig any type, Cranial/scalp prosthesis)

Suggested documentation to include with your reimbursement claim:

  1. Journal of the American Medical Association (JAMA) published scalp cooling study – download it here.
  2. Oncology Research and Treatmentpublished study on Scalp Cooling – download it here.
  3. Ask your doctor for a letter of medical necessity to include in your submission to the insurance company –download sample letter of medical necessity here.
  4. Ask your doctor for progress notes referencing that you are using scalp cooling to include with your claim

You may wish to talk to the financial coordinator at your doctor’s office if you have additional questions about your reimbursement paperwork.

Note that reimbursement may require multiple communications (by phone and in writing) with the insurance company. Insurance coverage varies among individual plans and may be dependent on policy coverage, location, and other factors stipulated by the insurance provider. Co-pays and minimums may also affect any reimbursements, depending on the plan details.

Requesting reimbursement from a third-party payer may not result in payment. Scalp cooling service may or may not be covered by the insurance company. Criteria such as co-pays and minimums may be a factor, and the dollar amount of coverage may vary. If it is not covered, no payment would result.  Additionally, there may be circumstances where the service is covered and thus can be used on a patient and billed for, but no additional payment would result.

Dignitana has no formal agreement with any third-party Payer (insurance company) and therefore cannot bill a third-party payer on your behalf for scalp cooling services. Coding, coverage, and payment of medical scalp cooling therapeutics for the prevention of chemotherapy-related alopecia has not yet become an industry standard.

Additional updates will be posted at dignicap.com/insurance


Are there grants available to pay for DigniCap?

Dignitana was a founding partner of HairToStay, a national non-profit foundation that provides subsidies to scalp cooling patients with demonstrated financial need.

In addition, some patients have received funding from individual medical center foundations, community health funds and other philanthropic entities that work to increase awareness and provide financial assistance to scalp cooling patients in their communities. Listed below are a few of these organizations. Ask your healthcare provider if there are any local or regional organizations in your area such as Cold Capital Fund serving the Washington DC area and Hope for Hair Foundation in North Carolina.

HairToStay
hairtostay.org

 

Cold Capital Fund
coldcapitalfund.org

 

Hope for Hair Foundation
hopeforhair.org

 


Can I use a coupon code I found on the internet to pay for DigniCap?

DigniCap does not offer these types of promo codes and they are not in any way related to DigniCap. We apologize for any confusion, but unfortunately the site you found is promoting fake codes or simply has the incorrect company information.


How do I pay for treatments?

Patients at some facilities pay Dignitana directly for their DigniCap treatments, while others are billed by their facility. Your provider will let you know which process they use.

If you have been told to create an account to pay Dignitana directly, you will use myDigniCap, the online payment portal to pay for your treatments. Once you have scheduled your chemotherapy appointment with your medical provider, please follow the directions below.

  1. Go to www.mydignicap.com
  2. In the top right of the screen click on REGISTER
  3. Under NEW ACCOUNT REGISTRATION, complete information
  4. In the CONSENT section, read and click on the arrows on the right to scroll down then click on “I have read…”
  5. In the PRIVACY section, read and click on the arrows on the right to scroll down then click on “I hereby acknowledge…”
  6. In the PAYMENT TERMS section, read and click on the arrows on the right to scroll down then click on “I have read…”
  7. In the FDA APPROVED BROCHURE section, select CLICK TO REVIEW to view the Patient Brochure (also available as the printed Patient Information Booklet at your doctor’s office). Click on “I have read…”
  8. Under SIGNATURE – type your name and today’s date
  9. Under ADDITIONAL TREATMENT INFORMATION – select the appropriate details for your chemo treatment
  10. Under myDIGNICAP ACCOUNT SETUP – enter your email address and create a password for myDigniCap
  11. Once all fields are complete, press SUBMIT to create account.
  12. Check your email for the account activation link
  13. Click on the link in your email to activate your account
  14. Enter the email address and password that you just provided in registration
  15. Congratulations – you have now created your myDigniCap account and logged in! The facility you indicated in Registration should show up in the “Pay for a Treatment” box – click PAY ONLINE
  16. Enter the date and information about your scheduled appointment
  17. Click PROCEED TO CHECKOUT
  18. Enter billing details and credit card information
  19. Click PLACE ORDER
  20. You will receive a receipt in your email, and the financial contact at your treatment facility will be notified that your payment for this scheduled treatment has been made and consent provided.

Once you have created the account, remember the password as you will sign back into the account before every treatment and pay. There is not an auto-bill feature, so you will need to pay and sign consent before every treatment.

4. HAIR CARE

How should I take care of my hair?

DigniCap offers you the chance to minimize hair loss during chemotherapy, but chemotherapy can cause scalp irritation, make the hair dry and brittle and more difficult to manage.

Click HERE for detailed Hair Care Recommendations. Here are some general suggestions:

  • Wash your hair at home prior to the scalp cooling/chemotherapy session. Oily hair may affect the thermal contact. Avoid daily shampooing (to avoid wear of the hair) and shampoo less if your hair begins to feel dry. It’s preferable to wash your hair no more than 1-2 times/week, including the wash the morning of treatment.
  • Use lukewarm water (avoid hot water) and gentle shampoo that is sulfate and paraben free.
  • Avoid applying heat to your hair with appliances such as a hair-dryer, curling iron, straightening iron, and hot rollers. Let your hair dry naturally as much as possible.
  • Avoid harsh chemicals that can lead to dry hair, breakage, progressive hair thinning and hair loss such as the following:
    – Peroxides for hair coloring
    – Perms to curl or straighten hair
    – Parabens (such a methylparaben and propylparaben), which are chemicals that are used as preservatives.
    – Sodium laurel sulfate, a foaming agent that can remove natural oils in the hair.
    – Silicones that are used to tame or “de-frizz” the hair work by coating the hair strands.
  • Limit combing hair. It’s recommended that you use a wide tooth comb and only comb your hair 1-2 times/day.
  • Avoid hair accessories such as rubber bands and headbands that pull on the hair.

How often can I wash my hair?

Wash your hair at home prior to the scalp cooling/chemotherapy session. Oily hair may affect the thermal contact. Avoid daily shampooing (to avoid wear of the hair) and shampoo less if your hair begins to feel dry. It’s preferable to wash your hair no more than 1-2 times/week, including the wash the morning of treatment. Use lukewarm water (avoid hot water) and gentle shampoo that is sulfate and paraben free.


How long do I continue with the limited hair washing?

Continue with limited hair washing until your shedding has returned to normal pre-chemotherapy levels.


How long do the hair follicles continue to be fragile after all the treatment is complete?

Three to six months


How should I take care of my hair after I finish chemotherapy and scalp cooling?

Follow the detailed Hair Care Recommendations provided for at least 2-3 months after your last chemo session, as the hair follicle will still be very fragile. The goal is to get your hair back to pre-chemo shedding levels and to allow the hair follicle to strengthen before adding heat and/or chemicals back into your hair care routine.

Once you are back to pre-chemo shedding levels, you can start to gradually introduce heat and other hair care products back into your routine. Try one product for a few days to see how your hair responds. Similarly, use the hair-dryer on a low and cool setting for several days to ensure your hair tolerates it, before using higher levels of heat.


Is it normal to still be shedding after I am finished with chemotherapy?

The chemo is still working in your body so you will still be experiencing some of the side effects. Shedding can continue to occur 2-3 months after treatment. We encourage patients to continue with the strict hair care recommendations for at least 2-3 months after treatment has stopped, as the hair follicle will still be very fragile. The goal is to get your hair back to pre-chemo shedding levels and to allow the hair follicle to strengthen before adding heat and/or chemicals back into your hair care routine.

Continue with the hair care recommendations, as we have seen this to be very helpful. Some patients have found that sleeping on a satin or silk pillow case is beneficial as it causes less friction on the scalp when sleeping. Some patients also use a cool-mist humidifier at night to help add moisture to their skin and scalp.


How often should I comb my hair?

It’s recommended that you use a wide tooth comb and to only comb your hair 1-2 times/day. Always gently comb your hair before washing it to remove any loose hairs and to prevent tangles and matting once it is wet.


What kind of shampoo should I use?

Use a gentle shampoo that is sulfate and paraben free and lukewarm water (avoid hot water). Avoid harsh chemicals that can lead to dry hair, breakage, progressive hair thinning and hair loss such as the following:

  • Parabens (such a methylparaben and propylparaben), which are chemicals that are used as preservatives.
  • Sodium laurel sulfate, a foaming agent that can remove natural oils in the hair.
  • Silicones that are used to tame or “de-frizz” the hair work by coating the hair strands.

What hair products can I use?

Staying away from any chemicals is best. Avoid harsh chemicals that can lead to dry hair, breakage, progressive hair thinning and hair loss such as the following:

  • Peroxides for hair coloring
  • Perms to curl or straighten hair
  • Parabens (such a methylparaben and propylparaben), which are chemicals that are used as preservatives.
  • Sodium laurel sulfate, a foaming agent that can remove natural oils in the hair.
  • Silicones that are used to tame or “de-frizz” the hair work by coating the hair strands.

Can I color my hair?

Staying away from any chemicals is best. Avoid harsh chemicals that can lead to dry hair, breakage, progressive hair thinning and hair loss such as the following:

  • Peroxides for hair coloring
  • Perms to curl or straighten hair

Can I use a hair dryer, curling or straightening iron, or hot rollers?

Avoid applying heat to hair with appliances such as a hair-dryer, curling iron, straightening iron, and hot rollers. Let your hair dry naturally as much as possible.


Can I cut my hair?

Yes, you can cut your hair. Please note, there is no advantage in cutting your hair short before chemo for scalp cooling purposes. It is better to go into chemo with as much hair as possible, but trimming your hair is fine.


What if I get matted hair on the back of my head?

Dampen your hair and add a fair amount of conditioner to the matted area.  Have another person work through the area slowly to ease out the knots with a comb. It may take time and patience, but do not cut the knot out with scissors. If this doesn’t work, visit a hair dresser for assistance.


Can I swim in the ocean or swimming pool during treatment?

It is recommended to avoid harsh chemicals that can lead to dry hair, breakage, progressive hair thinning and hair loss. It is not known whether chlorine or salt water will damage your hair during scalp cooling. Using a swim cap is not recommended because of the additional strain it puts on the hair follicles.


Can I go to the beach or layout in the sun?

It is recommended to avoid direct sunlight on your scalp, so it is best to stay out of the sun. Wearing a straw hat or a loose-fitting baseball cap is acceptable for a short period of time.


What happens to my hair if my head becomes warm in between treatments (such as during exercise, from night sweats, or from using a wig or hats)?

It is fine if your head becomes warm from other activities in between treatments. Avoid anything that pulls on your hair or rubs on the scalp.


Can I wear rubber bands and/or hair clips that pull on my hair?

You can wear your hair in a ponytail, but it is best to use a scrunchie and tie it back very loosely. Avoid putting too much strain on an individual patch of hair.


Can I wear hats, wigs, swim cap?

You can use a head covering that does not pull on the hair.


Do I need a wig or head covering?

The goal of scalp cooling is to reduce overall hair loss so that a wig, cap, scarf or other head covering is not needed. Any added stress or friction on the scalp and hair follicles may affect the outcome of treatment. However, the use of a wig or head covering may be desirable for reasons other than hair loss. For example, changes in hair color, hair texture, or hair quality, or for patients experiencing patchy hair loss or thinning. If you want to preserve the option to use a wig, you may wish to have a wig fitting before you start scalp cooling treatment to minimize friction on the scalp and hair follicles.

5. CONTRAINDICATIONS

Who should NOT use The DigniCap Scalp Cooling System (What are the contraindications?)

Contraindications

Pediatric patients should not use DigniCap.

Adult patients with the following conditions and cancer types should not use DigniCap:

• 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

Scalp cooling is contraindicated if chemotherapy with a curative intent is given to patients with hematological malignancies or with solid tumor malignancies with a high likelihood of metastases in transit.


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.

Please note that the content of this website is not intended as professional medical or healthcare advice and should not be construed as a substitute for professional healthcare advice, or services from a qualified professional healthcare provider familiar with your unique situation. This content is intended solely as a general product and corporate information.

OPERATIONS
Dignitana
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Dallas, TX 75238
+1 877-350-2150

HEADQUARTERS
Dignitana AB
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226 60 Lund, Sweden
+46 46 16 30 90