Clinical trial · Interventional
Efficacy and Safety of DIGNICAP™ System
A Study on the Efficacy and Safety of DIGNICAP™ System for Preventing Chemotherapy Induced Alopecia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chemotherapy-induced alopecia (CIA) is one of the most common and emotionally distressing side effects of cancer therapy. In this study we sought to assess the feasibility and the effectiveness of scalp cooling system DigniCap® to prevent alopecia in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT). A prospective two-stage design clinical trial conducted at a single Institution of women with primary breast cancer scheduled to receive anthracycline with or without taxane-based adjuvant CT. Patients were enrolled from July 2014 to November 2016, with ongoing annual follow up for 5 years. The scalp cooling period initiated approximately 30 minutes before CT. Scalp temperature was to be maintained at 3-5°C throughout CT and for 90 to 120 minutes afterward, depending on the CT drug and dose.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Alopecia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DIGNICAP™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DIGNICAP™
- description
- DigniCap® System
- interventionNames
- Device: DIGNICAP™
Primary outcomes (1)
- measure
- Reduction of hair loss
- timeFrame
- 21 days
- description
- Hair loss (HR) assessed by the patient herself after completing the last cycle of chemotherapy (21 days after last CT infusion) using photographs taken 5 angles using a VAS (Visual Analogue Scale) (Grade 0: no hair loss; Grade 1: \< 25% hair loss; Grade 2: 25-50% of hair loss; Grade 3: 50-75% of hair loss; Grade 4: \>75% of hair loss)
Secondary outcomes (6)
- measure
- Hair loss assessed by physician
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women \> 18 years of age Performance status (ECOG) 0- 1 * Documented diagnosis of stage I or II breast cancer * A planned course of chemotherapy in the adjuvant setting with curative intent including one of the following regimens: * Doxorubicin 60 mg/m2 or Epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 x 4 cycles IV every 3 weeks * Docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 x 4 cycles IV every 3 weeks * Paclitaxel 80 mg/m2 weekly IV x at least 12 weeks with or without IV trastuzumab * Docetaxel 75-100 mg/m2 IV every 3 weeks x 4 cycles with or without trastuzumab IV weekly or every 3 weeks * Targeted agents such as trastuzumab are allowed * Patients receiving a regimen including both an anthracycline and a taxane (at doses reported above) are also eligible for this trial (AC/T, EC/T, TAC, etc.) * Plan to complete chemotherapy within 6 months * Willing and able to sign informed consent for protocol treatment * Willing to participate in study procedures including having photographs of the head before the first cycle of chemotherapy and 1 month after the last chemotherapy * Willing to enroll in an extension protocol for follow up for 5 years following the end of chemotherapy treatment * Negative pregnancy test (in fertile women). Exclusion Criteria: * Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale * Previous chemotherapy * Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss * A history of whole brain radiation * Plans to use a chemotherapy regimen other than those specified in the inclusion criteria. * Concurrent hormone therapy with chemotherapy except LHRH analogue. Hormone therapy should be used as indicated following completion of chemotherapy * Underlying clinically significant liver disease including active viral hepatitis with abnormal liver function tests \>1.5 times the upper limit of normal, including alkaline phosphatase, AST, and total bilirubin. Patients with Gilbert´s disease (elevated indirect bilirubin only) will be eligible for participation. * Clinically significant renal dysfunction defined as serum creatinine \> upper limit of normal. * A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up * A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens * Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause hair loss Intercurrent life-threatening malignancy * A history of cold agglutinin disease or cryoglobulinemia. * Evidence of untreated or poorly controlled hyper or hypothyroidism * A history of silicon allergy
References
Publications (1)
- DERIVEDMunzone E, Bagnardi V, Campenni G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019 Aug;121(4):325-331. doi: 10.1038/s41416-019-0520-8. Epub 2019 Jul 15. PMID 31303642