Frequently Asked Questions


Sections:

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

 


SECTION 1 – SCALP COOLING OVERVIEW


What is scalp cooling?

Some chemotherapy drugs can damage your hair cells. Cooling of the scalp is a proven approach to reduce chemotherapy-induced hair loss that has been used successfully by thousands of patients worldwide. The reduced temperature results in a reduced 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. In addition, cellular metabolism within the hair cells is slowed down. 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. The blood vessels in the localized scalp area constrict (vasoconstriction): the narrowed blood vessels limit the amount of chemotherapy agents delivered to scalp area.
  2. The metabolism slows down: a reduced scalp temperature causes normal cellular activity in the localized scalp area to slow dramatically. This means that much fewer chemotherapy agents become 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 July 3,2017 the U.S. FDA granted DigniCap clearance to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors, so it is now cleared for both men and women. DigniCap was also the first scalp cooling device to receive FDA clearance, which was granted December 8, 2015 for use by women with Breast Cancer undergoing chemotherapy.

How is DigniCap different from other scalp cooling treatments?

DigniCap was the first scalp cooling system to be cleared by the FDA in December of 2015 for the treatment of breast cancer patients in the U.S. In July 2017, DigniCap clinical indications were expanded to include solid tumor cancers in men and women.

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 monitors scalp temperature and a third safety sensor to ensure that the scalp temperature never falls below freezing point. Also, the cooling cap is fitted once at the start 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?

DigniCap will be used during each cycle of chemotherapy administration.

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/hair maintenance recommendations during treatment.
  3. I understand that scheduling of treatment will depend on the availability of a DigniCap machine. 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 (from 90 minutes to 3 hours) 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 30-150 minutes following the completion of their chemotherapy infusion. Typically, it ranges from 90-150 minutes. After completion of the post-infusion cooling time, the cooling cap remains on your scalp for another 5-10 minutes to allow 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 also prefer to bring their own towel as well, which is used when you are wetting your hair before putting on the cap.


SECTION 2 – HAIR LOSS AND EFFECTIVENESS

Will I lose some hair during scalp cooling?

Yes, 66.3% of patients in the multi-center clinical study kept at least 50% of their hair. Typically, patients will start to see shedding (overall thinning of the hair) around 18-21 days from the initial chemo treatment. If you are on a weekly dosage that is not as strong, you may see more shedding around weeks 4-5. Effectiveness is dependent on several factors including chemotherapy regimen, dose, duration of drug infusion, chemotherapy drug metabolism, and concomitant comorbidities.

How effective is scalp cooling?

66.3% of patients using DigniCap in the multi-center clinical study kept 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?

Cooling of the scalp is a proven approach to reduce chemotherapy-induced hair loss 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 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 of 2015 to specifically reduce the likelihood of chemotherapy-induced alopecia in women with breast cancer. In July of 2017, DigniCap received clearance for use with solid tumor cancers in men and women.

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 is 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.


SECTION 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 the blank reimbursement claim form from your insurer (you may be able to download this from their website)
  2. If you are using form CMS 1500 for Medicare, directions are posted here
  3. DIAGNOSIS – Ensure ICD codes on claim form you submit exactly match your diagnosis. Your

diagnosis code will likely be in this range: 0 – C96.9 (Malignant neoplasms)

  1. DIAGNOSIS -In the same diagnosis box, provide a second diagnosis code of Z51.11 (Encounter for antineoplastic chemotherapy)
  1. PROCEDURE, SERVICE OR SUPPLY – enter CPT code 97039 (Constant attendance, physical medicine, scalp cooling, unlisted modality). There is not a unique CPT code for scalp cooling, and a CPT code may not be required on your form if other criteria are met.
  2. CHARGE – Ask your Third Party Payer (insurance company) how they prefer to have this section completed
  3. Include a copy the Feb 14 JAMA Article on Scalp Cooling – download it here
  4. Include a copy the Oncology Research and Treatment article on Scalp Cooling – download it here
  5. Ask your doctor for a letter of medical necessity and include that in your initial submission to the insurance company – download sample here
  6. Ask your doctor for progress notes that reference that you are using scalp cooling and include that in your initial submission to the insurance company
  7. Reimbursement may require multiple communications (by phone and in writing) with the insurance company.
  8. 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 effect any reimbursements, depending on the plan details.

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. 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.

Additional updates will be posted at www.dignicap.com/insurance

Are there grants available to pay for DigniCap?

To provide patients with financial assistance, Dignitana was a founding partner and continues to be a strong supporter of HairToStay, a national non-profit foundation that provides subsidies to scalp cooling patients with demonstrated financial need. Visit www.hairtostay.org for more information.

In addition, some facilities have utilized funding from medical center foundations, community health funds and other philanthropic entities to support scalp cooling in their community. Ask your nurse or clinical coordinator about these options.

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 sessions, and others are billed by the 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.


SECTION 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. Visit dignicap.com/haircare to download the hair care brochure. Here are some general suggestions:

  • Wash your hair at home prior to the scalp cooling/chemotherapy session. Greasy hair may affect the thermal contact. However, avoid daily shampooing (to avoid wear of the hair), shampoo less if your hair feels dry. It’s preferable to wash no more than 1-2 times/week, with the washing the morning of treatment counting as 1 washing.
  • Use lukewarm water (avoid hot water) and gentle shampoo that is sulfate and paraben free.
  • Avoid applying heat to hair with appliances such a blow-dryers, curling irons, 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) are chemicals that are used as preservatives
  • Sodium laurel sulfate is a foaming agent and will 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. Greasy hair may affect the thermal contact. However, avoid daily shampooing (to avoid wear of the hair), shampooing 1-2 times/week is suggested, shampoo less if your hair feels dry. 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?

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 hair care products. Reintroduce these gradually. Try one product for a few days to see how your hair responds. Then you could slowly start adding in other products.  Similarly, use the hair dryer on low and on cool heat for several days to ensure your hair tolerates it, before using higher heat levels.

How often should I comb my hair?

Comb your hair so that you can remove the loose hair from (the scalp) shedding before it gets tangled into the rest of the hair using a wide toothed comb. Comb your hair before washing it, to remove any excess loose hairs and prevent tangles or matting afterwards.

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) are chemicals that are used as preservatives
  • Sodium laurel sulfate is a foaming agent and will 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) are chemicals that are used as preservatives
  • Sodium laurel sulfate is a foaming agent and will 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 a blow-dryers, curling irons, 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 to cutting it 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 put tons of conditioner on it, and then have someone else work through it slowly to ease out the knots with a comb. It takes 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 a good idea, since it would pull on the hair.

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

Avoid direct sunlight on your scalp. It is best to stay out of the sun. Wearing a straw hat or a loose-fitting baseball cap is okay 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 okay if your head becomes warm from other activities between treatments. Just 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.


SECTION 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 receiving tamoxifen
  • 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.

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 (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.

Helpful Tips from The Rapunzel Project

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Information for
Patients

Learn about reducing hair loss for yourself or a loved one. Hear patients tell their stories about scalp cooling. Find out  where DigniCap® is available near you.

 

 

 

 

 

Information for
Healthcare Professionals

 

Find out how scalp cooling can help your patients. Read about the science behind scalp cooling and clinical research findings on safety and efficacy.

 

 

Learn about
Availability

Find out where The DigniCap® Scalp Cooling System is currently available.