Alopecia, Breast Cancer
Conditions
Keywords
Breast Cancer, Alopecia, Scalp, Cooling
Brief summary
Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.
Detailed description
Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may stop patients who are undergoing chemotherapy from losing their hair.
Interventions
DEVICEPAXMAN Orbis Scalp Cooler
Treatment with Orbis scalp cooling cap
OTHERControl No treatment
No treatment to prevent hair loss
Sponsors
Julie Nangia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
One blinded observer assesses the patient outcome
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New diagnosis of breast cancer stage 1-2 * Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent * Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen, * Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses * Concurrent traztuzumab at standard doses is allowed * Concurrent pertuzumab at standard doses is allowed * Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated. * Subjects must have TSH collected within 1 year prior to treatment and found within normal range. * If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits. * CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits.
Exclusion criteria
* Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma) * Baseline alopecia (defined CTCAE v4.0 grade \> 0, see appendix B for CTCAE v4.0 scale) * Subjects with cold agglutinin disease or cold urticaria * Subjects who are scheduled for bone marrow ablation chemotherapy * Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC) * Male gender * Age \>= 70 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Preservation | 4 to 8 Months | The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Recurrence and Overall Survival | 5 years | A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Improved Quality of Life | 4 to 8 Months | Improved quality of life as a result of reduced hair loss is a primary motivator for developing the Paxman Scalp Cooling device. Quality of life will be assessed at baseline and 2-3 weeks after each course of chemotherapy. Three widely used and validated scales will be used: the EORTC QLQ C-30, HADS and BIS. Subjects will be evaluated at multiple time points and data will be analyzed using descriptive methods with median and inter quartile rang to assess the effect of treatment group and alopecia status on functioning, quality of life and depression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Scalp Cooling Scalp Cooling
PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap | 157 |
| Non-cooling Control
Control No treatment: No treatment to prevent hair loss | 79 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | alternative treatment | 1 | 1 |
| Overall Study | found not eligible | 3 | 0 |
| Overall Study | progression disease | 0 | 1 |
| Overall Study | Withdrawal by Subject | 31 | 25 |
Baseline characteristics
| Characteristic | Scalp Cooling | Total | Non-cooling |
|---|---|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 10.1 | 50.4 years STANDARD_DEVIATION 10.3 | 50.6 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 37 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants | 196 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 29 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 130 Participants | 192 Participants | 62 Participants |
| Region of Enrollment United States | 157 participants | 236 participants | 79 participants |
| Sex: Female, Male Female | 157 Participants | 236 Participants | 79 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 0 |
| other Total, other adverse events | 39 / 137 | 0 / 0 |
| serious Total, serious adverse events | 0 / 137 | 0 / 0 |
Outcome results
Primary
Hair Preservation
The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment.
Time frame: 4 to 8 Months
Population: Randomized patients who underwent at least one cycle of chemotherapy were evaluable for efficacy. 27 patients in the cooling group and 25 patients in the non-cooling group did not start chemotherapy or discontinued during the 1st cycle were excluded from the efficacy analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Scalp Cooling | Hair Preservation | success | 69 Participants |
| Scalp Cooling | Hair Preservation | failure | 61 Participants |
| Non-cooling | Hair Preservation | success | 0 Participants |
| Non-cooling | Hair Preservation | failure | 54 Participants |
Secondary
Time to First Recurrence and Overall Survival
A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation
Time frame: 5 years
Other Pre-specified
Improved Quality of Life
Improved quality of life as a result of reduced hair loss is a primary motivator for developing the Paxman Scalp Cooling device. Quality of life will be assessed at baseline and 2-3 weeks after each course of chemotherapy. Three widely used and validated scales will be used: the EORTC QLQ C-30, HADS and BIS. Subjects will be evaluated at multiple time points and data will be analyzed using descriptive methods with median and inter quartile rang to assess the effect of treatment group and alopecia status on functioning, quality of life and depression.
Time frame: 4 to 8 Months