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| Name | Class |
|---|---|
| Medical Specialties of California | UNKNOWN |
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The goal of this study is to estimate the efficacy of Penguin cold caps in preventing or reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common regimens) for early stage breast cancer.
This will be a phase II prospective, open label, non-randomized study conducted to determine the safety and efficacy of Penguin TM cold cap system in preventing or reducing chemotherapy-induced alopecia in patients with early stage breast cancer undergoing chemotherapy.
Eligible subjects will be enrolled to one of 4 study arms determined by type of chemotherapy. Subjects will have early stage breast cancer of any receptor subtype, for which standard of care includes chemotherapy. Eligible subjects will be enrolled at Providence Portland Medical Center (PPMC) and Providence St. Vincent Medical Center (PSVMC).
The PenguinTM cold cap therapy will be administered to all enrolled subjects according to the dosing schedule specified by the study arms. PenguinTM cold caps is a portable scalp cooling system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30 minutes in order to maintain optimum temperature. Its unique crylon gel formula is specifically created to maintain cold temperatures for much longer periods of time than other conventional cooling gels and foams. No scalp preparation is required before use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penguin Cold Caps | Experimental | Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penguin Cold Caps | Device | Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA | Efficacy will be reported as the proportion of evaluable subjects in each arm who achieve a score of 0-2 on the Dean's alopecia scale (i.e. less than 50% hair loss by standardized photography) at the 30-day post-chemotherapy assessment visit. A modified intention-to-treat (ITT) analysis will be followed whereby all subjects receiving at least 75% of prescribed chemotherapy dose will be considered evaluable (those receiving less chemotherapy are excluded to minimize confounding effect of chemotherapy dose). Subjects who withdraw consent prior to efficacy assessment will constitute treatment failures according to the intention-to-treat principle. Dean's alopecia scale is as follows: Grade 0 indicates no hair loss, Grade 1 indicates up to 25% hair loss, Grade 2 indicates greater than 25% hair loss up to 50% hair loss, Grade 3 indicates greater than 50% hair loss up to 75% hair loss, and Grade 4 indicates greater than 75% hair loss. | 30 days post chemotherapy treatment |
| Measure | Description | Time Frame |
|---|---|---|
| "Was It Worth It?" Questionnaire Exit Interview | Patient reported outcomes (PROs) will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial for the WIWI scale. | 30 days post chemotherapy treatment |
| EORTC QLQ-C30 Exit Interview |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Page, MD | Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Cancer Center | Portland | Oregon | 97213 | United States |
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Slow accrual and exhausted funding led to only 12 patients enrolled instead of the planned 20.
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| ID | Title | Description |
|---|---|---|
| FG000 | Penguin Cold Caps | Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy. Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Population analyzed reduced to 10 for publication due to two patients withdrawing before Cycle 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Penguin Cold Caps | Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy. Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA | Efficacy will be reported as the proportion of evaluable subjects in each arm who achieve a score of 0-2 on the Dean's alopecia scale (i.e. less than 50% hair loss by standardized photography) at the 30-day post-chemotherapy assessment visit. A modified intention-to-treat (ITT) analysis will be followed whereby all subjects receiving at least 75% of prescribed chemotherapy dose will be considered evaluable (those receiving less chemotherapy are excluded to minimize confounding effect of chemotherapy dose). Subjects who withdraw consent prior to efficacy assessment will constitute treatment failures according to the intention-to-treat principle. Dean's alopecia scale is as follows: Grade 0 indicates no hair loss, Grade 1 indicates up to 25% hair loss, Grade 2 indicates greater than 25% hair loss up to 50% hair loss, Grade 3 indicates greater than 50% hair loss up to 75% hair loss, and Grade 4 indicates greater than 75% hair loss. | Posted | Count of Participants | Participants | 30 days post chemotherapy treatment |
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Penguin Cold Caps | Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy. Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head Sore | Skin and subcutaneous tissue disorders | Systematic Assessment | Grade 1 head sore possibly attributed to cold-capping. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David B. Page | Earle A. Chiles Research Institute, Providence Cancer Institute | 503-215-6588 | david.page2@providence.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2019 | Apr 6, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 4, 2020 | Apr 6, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Patients will use the Penguin Cold Caps during prior to, during, and after chemotherapy administration. Cold-cap therapy will commence at least 50 minutes prior to infusion, and will continue for 4 hours following completion of chemotherapy.
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Optional patient reported outcomes (PROs) for European Organization for Research and Treatment of Cancer: Quality of Life Core-30 (EORTC QLQ-C30), version 3.0. The EORTC QLQ-C30 covers five functional scales and three symptom scales. Scores range from 0 to 100 with higher scores indicate a better quality of life/outcome 30 days post chemotherapy treatment. |
| 30 days post chemotherapy treatment |
| BR23 Exit Interview | Patient reported outcome (PRO) using the European Organization for Research and Treatment of Cancer: Quality of Life Breast Cancer Module (EORTC QLQ-BR23) and body image scale (BIS). For the QLQ-BR23, scores range from 0 to 100, with higher scores indicating better quality of life for patients. For the BIS, scores range from 0 to 30, with a higher score indicating a higher level of body image disturbance. | 30 days post chemotherapy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Menopausal Status | Count of Participants | Participants |
|
| Chemotherapy Setting | Count of Participants | Participants |
|
| Hair Thickness | Count of Participants | Participants |
|
| Penguin Cold Caps |
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy. Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration. |
|
|
| Secondary | "Was It Worth It?" Questionnaire Exit Interview | Patient reported outcomes (PROs) will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial for the WIWI scale. | Posted | Number | participants | 30 days post chemotherapy treatment |
|
|
|
| Secondary | EORTC QLQ-C30 Exit Interview | Optional patient reported outcomes (PROs) for European Organization for Research and Treatment of Cancer: Quality of Life Core-30 (EORTC QLQ-C30), version 3.0. The EORTC QLQ-C30 covers five functional scales and three symptom scales. Scores range from 0 to 100 with higher scores indicate a better quality of life/outcome 30 days post chemotherapy treatment. | Eight subjects participated in the optional exit interview. | Posted | Mean | Standard Deviation | score on a scale | 30 days post chemotherapy treatment |
|
|
|
| Secondary | BR23 Exit Interview | Patient reported outcome (PRO) using the European Organization for Research and Treatment of Cancer: Quality of Life Breast Cancer Module (EORTC QLQ-BR23) and body image scale (BIS). For the QLQ-BR23, scores range from 0 to 100, with higher scores indicating better quality of life for patients. For the BIS, scores range from 0 to 30, with a higher score indicating a higher level of body image disturbance. | 8 of the 10 patients participated in the optional exit interview. | Posted | Mean | Standard Deviation | score on a scale | 30 days post chemotherapy |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
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| Headache | Nervous system disorders | Systematic Assessment | Not related to cold capping treatment. |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Not related to cold capping treatment. |
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| Syncope | Nervous system disorders | Systematic Assessment | Not related to cold capping treatment. |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment | Not related to cold capping treatment. |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Subjects reporting improved quality of life (QOL) |
|
| Better experience than expected |
|
| Title | Measurements |
|---|---|
|
| Functional Scale: Emotional |
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| Functional Scale: Cognitive |
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| Functional Scale: Social |
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| Symptom Scale: Financial Difficulties |
|
|