Chemotherapy induced alopecia (CIA), scalp cooling, and the DigniCap Delta Scalp Cooling System

Chemotherapy induced alopecia (CIA), scalp cooling, and the DigniCap Delta Scalp Cooling System

Scalp Cooling is clinically proven to be effective in solid tumor cancers

Cancer is a collection of related diseases that involve the cells in the body becoming abnormal by rapidly dividing and spreading to surrounding areas and forming growths or malignant tumors.

Cancers that commonly used chemo regimens that can use Scalp Cooling:

Breast Cancer
Gynecological (GYN) Cancers such as Ovarian, Endometrial, Cervical
Prostate Cancer
Pancreatic Cancer
Certain Lung Cancers

Chemotherapy

Chemotherapy is a type of cancer treatment that uses one or more cytostatic drugs to inhibit the cell growth and division of abnormal cells, as well as kill cancer cells that have spread to other parts of the body away from the original tumor.

Single-Agent Chemotherapy drugs are frequently used with DigniCap Delta Scalp Cooling.

Some chemo regimens may not be commonly used with scalp cooling but could be used under medical direction. Most regimens consist of 1 or 2 chemotherapeutic drugs received on one day, but when regimens consist of 3 or 4 drugs that cause hair loss are used together, the likelihood of achieving a good outcome diminishes. However, that does not mean a patient cannot try scalp cooling.

American Cancer Society: How chemotherapy works

References:

Why Chemotherapy Causes Alopecia (Hair Loss)

Alopecia is a common side effect of many of the cytostatic drugs given during chemotherapy. Cytostatics work by actively targeting rapidly dividing cells, and hair follicles are some of the fastest growing cells in the body. Because chemotherapy cannot distinguish between normal rapidly dividing cells and cancerous cells, the hair follicles are often affected.

Why Scalp Cooling Matters

A patient’s hair can be a major part of their identity, and many patients rate hair loss as one of the most devastating side effects of chemotherapy. Chemotherapy-induced alopecia is an unwelcome reminder of cancer, one that can negatively affect self-image, confidence, overall sense of well-being and a patient’s attitude toward treatment.

History of Cold Caps and Scalp Cooling

Cold caps and scalp cooling have been used in various forms since the 1970s when some cancer patients would place bags of frozen vegetables or ice packs on their heads to try to stop chemotherapy from “burning” their hair. Although the mechanism of the treatment was not yet understood, the foundation for cooling the scalp to minimize chemotherapy-induced alopecia was born.

In the 1990s oncology nurse Yvonne Olofsson was working with cancer patients and their families in Sweden. She saw firsthand the traumatic effect of hair loss on her patients and recognized the impact it had on their physical and emotional well-being. Working with engineer John Kern, Yvonne Olofsson developed a new system to reduce hair loss from chemotherapy. Their device consisted of a molded cap that was attached to cooling unit.

Patented in 1996, the scalp cooling device they invented was named DigniCap with the name inspired by the Latin word dignitas meaning Dignity.

How Cold Caps and Scalp Cooling Work

Reduced temperature results in a decreased blood flow to the scalp area so that less chemotherapy reaches the hair cells. Therefore, hair cells are 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.

Two physiologic reactions occur during scalp cooling:

Reduced blood flow
Vasoconstriction in the scalp area limits the amount of chemotherapy agent delivered to the hair follicles.
Reduced metabolism
Lower scalp temperature decreases the reaction rate causing normal cellular activity in the localized scalp area to slow dramatically.

With these two reactions the follicles absorb fewer chemotherapy agents and hair loss is significantly reduced.

Proven Efficacy

Scalp cooling is a proven approach to reduce chemotherapy-induced alopecia that has been used successfully by thousands of patients worldwide for decades.

Dozens of studies around the world have been published on the efficacy of scalp cooling.

The DigniCap Bibliography page provides an overview of studies and abstracts that have been published on The DigniCap Scalp Cooling System.

DigniCap Indication for Use

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

Contraindications

The use of DigniCap is contraindicated in pediatric patients.

The use of DigniCap is contraindicated in adult patients with:

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

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 on the same infusion day has not been shown to be successful in preventing chemotherapeutic drug induced alopecia. The DigniCap Scalp Cooling System should not be used in these patients.

Scalp radiation can cause stenosis or hardening 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.

There is a potential for cold injury, even when providing cooling within the prescribed treatment settings. Special care should be taken when applying the Cooling Wrap to ensure that there is no direct contact between a patient’s exposed skin and the wrap’s cooling surface. Patients should use the provided headband around their hairline to prevent direct skin contact with the Cooling Wrap.

Individuals who experience any unusual swelling, skin discoloration or discomfort should immediately discontinue the use of the DigniCap System.

Quality of Life

Minimizing hair loss helps patients to preserve personal identity and self-esteem and appear normal as opposed to sick. Protecting privacy and gaining the ability to choose whether to disclose a cancer diagnosis is significant to many patients.

Additionally, scalp cooling patients gain a much-needed sense of control in an otherwise overwhelming experience.

As Published
Body image in women with breast cancer using a scalp cooling system to reduce chemotherapy induced alopecia.
San Antonio Breast Cancer Symposium Abstract, December 2016
Cigler, T, et al.

A total of 117 patients were enrolled in the pivotal trial. 101 received scalp cooling using DigniCap and 16 were in the control group with no scalp cooling.

Summary

Women with breast cancer receiving scalp cooling using DigniCap versus control during chemotherapy:

Were significantly less likely to lose ≥ 50% of their hair
Felt significantly more physically attractive
Were significantly less dissatisfied with their appearance when dressed
Regarded the importance of hair significantly more

Body Image in Women With Breast Cancer Using a Scalp Cooling System to Reduce Chemotherapy Induced Alopecia.

How Alopecia Concern Impacts Treatment

A study published in Cancer Practice found that 8-10% of female patients refuse chemotherapy due to concern over hair loss.¹

McGarvey EL, et al. Psychological sequelae and alopecia among women with cancer. Cancer Pract. 2001Nov-Dec;9(6):283-9.

Scalp Cooling Consumer Study

Online questionnaire administered March 2015.

Demographic Profile

400 females surveyed
All ethnicities
All states in the U.S.
Wide range of household incomes
No knowledge of medical history
Age distribution: 40-49 (125), 50-59 (175), 60+ (100)

Interest in Scalp Cooling

After a short introduction in scalp cooling, 96% of participants showed interest in scalp cooling to minimize hair loss from chemotherapy.

Ranking of Chemotherapy Side Effects

Of participants, 28.2% identified hair loss as the most concerning side effect of chemotherapy.

Medical Center Selection

After a short introduction in scalp cooling, 80.5% of participants responded that the availability of scalp cooling is important when selecting a provider.

Recognized as Standard of Care

National Comprehensive Cancer Network

NCCN® recognizes scalp cooling as a Category 2A recommendation to reduce the incidence of chemotherapy-induced alopecia for breast cancer (Version 1.2019) and ovarian cancer (Version 1.2020).

The National Comprehensive Cancer Network is an alliance of 30 cancer centers in the United States, most of which are designated by the National Cancer Institute as comprehensive cancer centers. For more information on NCCN visit www.nccn.org

ESMO Clinical Practice Guidelines

The ESMO Clinical Practice Guidelines released in 2020 state that scalp cooling is recommended to prevent chemotherapy-induced alopecia.

The recommendations were published in the Annals of Oncology, the journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology.

For more information on ESMO and the Annals of Oncology visit esmo.org

Cancer Australia

In 2020, Cancer Australia released recommendations in the Guidance for the management of early breast cancer stating that scalp cooling should be considered to reduce the risk of hair loss for patients receiving chemotherapy, noting scalp cooling may be less effective with anthracycline-containing regimens.

Cancer Australia was established by the Australian Government in 2006 to benefit all Australians affected by cancer. For more information about Cancer Australia visit canceraustralia.gov.au

Insurance Reimbursement in the United States

In October 2020, the American Medical Association (AMA) announced the approval of Current Procedural Terminology (CPT®) codes for Mechanical Scalp Cooling Services. These new CPT codes became effective for use in July 2021, increasing patient access to scalp cooling treatments.

The two new Category III CPT codes for scalp cooling supports the pathway to insurance reimbursement in the United States.

Common Concerns and Misconceptions

Is scalp cooling only for breast cancer?

In 2015, after a rigorous review by the FDA, DigniCap was the first scalp cooling system to receive clearance in the United States. It was concluded that The DigniCap Scalp Cooling System prevented hair loss in 66.3% of patients with breast cancer receiving adjuvant chemotherapy, compared to a control group where all patients experienced significant hair loss.

In 2017, the FDA expanded DigniCap’s clearance to include men and women receiving chemotherapy to treat solid tumors from breast cancer as well as those from prostate, ovarian, uterine, lung and other tissues.

The efficacy of scalp cooling has more to do with the type of chemotherapy drugs being administered than the type of cancer itself. Scalp cooling is most effective when used with taxanes, but recent studies have shown that it is also effective with anthracyclines.

Does scalp cooling increase the risk of Scalp Metastases?

Metastasis occurs when cancer spreads to other parts of the body. Some doctors and patients have asked whether scalp cooling increases the chance of metastases in the scalp.

A study published in 2017 reviewed patients with breast cancer receiving chemotherapy while using scalp cooling for hair preservation and found there was no statistical difference in the incidence of scalp metastasis between patients using scalp cooling vs. no scalp cooling.

The study concluded that “based on this extensive review and meta-analysis, scalp cooling is highly unlikely to increase the incidence of scalp metastases in patients with early-stage breast cancer receiving adjuvant chemotherapy.”

Findings: 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.

As Published

Scalp cooling with adjuvant/neoadjuvant chemotherapy for breast cancer and the risk of scalp metastases: systematic review and meta-analysis.
Breast Cancer Research and Treatment, 2017: 163:199–205
Rugo, H, et al.

Multiple articles have also appeared in industry publications including; New England Journal of Medicine, Med Tech Intelligence, medGadget, Medical Plastic, and Oncology Nurse Advisor.

DigniCap Delta

Designed According to Direct Marketing Feedback

DigniCap Delta was designed with clinicians and patients in mind. Developed with direct feedback from Dignitana partner sites, DigniCap Delta improves the clinical process, reduces nursing intervention and optimizes patient outcomes.

Product Overview

DigniCap Delta consists of a thermoelectric cooling unit with a computerized control system operated via a touchscreen monitor. An adjustable Cooling Wrap is connected to the cooling unit.

DeltaCool coolant is circulated from the device through the Therapy Hose to small channels within the Cooling Wrap. Circulating fluid temperature is monitored by two separate sensors in DigniCap Delta, one that measures the fluid supply to the Cooling Wrap and one measuring the return flow. An additional sensor monitors supply fluid temperatures as a backup to assure patient safety.

The Cooling Wrap can be easily disconnected from the DigniCap Delta device when necessary, for example, to facilitate restroom visits. To insulate and keep the Cooling Wrap in place, a neoprene Thermal Cap is used over the Cooling Wrap.

What makes DigniCap Delta better than other scalp cooling systems?

Stable and efficient thermoelectric cooling system
Improved patient comfort from flexible cap design and quiet and consistent coolant flow
Single patient cap system
Flexible cooling wrap for precise fit
Adjustable thermal cap to maintain close contact
Intuitive user interface
Device portability with transport battery

Compelling Benefits

Improved Patient Outcomes

The Cooling Wrap and Thermal Cap provide patients with a custom fit for optimal outcomes.

Ease of Use for Clinical Staff

DigniCap Delta was designed for ease of use by clinicians.

Single patient unit for flexibility in tight spaces
Comfortable cap fit with adjustable tabs and chin strap for an easy fit
Patient mobility for post-infusion cooling to increase efficiency and reduce valuable chair time
Intuitive user interface for ease of operation
Quick connect allows clinicians to easily transition hose connection
Ergonomic design for clinical staff and patients
54% smaller than previous device
Up to 80% reduction in nursing time

Infection Prevention

The DigniCap Delta single-patient Cooling Wrap aids in infection control and provides hygienic benefits especially in light of COVID-19 protocols.