Scalp Cooling to Prevent Chemo-induced Hair Loss (SCALP)

• ClinicalTrials.gov Identifier: NCT01986140
• Recruitment Status: Unknown
• First Posted: November 18, 2013
• Results First Posted: October 16, 2018
• Last Update Posted: July 27, 2021
• Sponsor: Julie Nangia
• Information provided by (Responsible Party): Julie Nangia, Baylor Breast Care Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Care Provider); Primary Purpose: Treatment
• Conditions: Breast Cancer; Alopecia
• Interventions: Device: PAXMAN Orbis Scalp Cooler; Other: Control No treatment
• Enrollment: 236

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	PAXMAN Orbis Scalp Cooler	Control No Treatment
Arm/Group Description	Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap	Control Control No treatment: No treatment to prevent hair loss
Period Title: Overall Study
Started [1]	157	79
Completed [2]	122	51
Not Completed	35	28
Reason Not Completed
Withdrawal by Subject	31	25
alternative treatment	1	1
found not eligible	3	0
Adverse Event	0	1
progression disease	0	1
[1] subjects who were randomized; [2] subjects who underwent scalp cooling or non-cooling for a 4 cycles of chemotherapy

Baseline Characteristics

Arm/Group Title		Scalp Cooling	Non-cooling	Total
Arm/Group Description		Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap	Control Control No treatment: No treatment to prevent hair loss	Total of all reporting groups
Overall Number of Baseline Participants		157	79	236
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	157 participants	79 participants	236 participants
		50.4 (10.1)	50.6 (10.6)	50.4 (10.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	157 participants	79 participants	236 participants
	Female	157 100.0%	79 100.0%	236 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	157 participants	79 participants	236 participants
	Hispanic or Latino	25 15.9%	12 15.2%	37 15.7%
	Not Hispanic or Latino	130 82.8%	66 83.5%	196 83.1%
	Unknown or Not Reported	2 1.3%	1 1.3%	3 1.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	157 participants	79 participants	236 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	5 3.2%	5 6.3%	10 4.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	19 12.1%	10 12.7%	29 12.3%
	White	130 82.8%	62 78.5%	192 81.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	3 1.9%	2 2.5%	5 2.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	157 participants	79 participants	236 participants
		157	79	236

Outcome Measures

1. Primary Outcome

Title	Hair Preservation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Scalp Cooling	Non-cooling
Arm/Group Description:	Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap	Control Control No treatment: No treatment to prevent hair loss
Overall Number of Participants Analyzed	130	54
Measure Type: Count of Participants; Unit of Measure: Participants
success	69 53.1%	0 0.0%
failure	61 46.9%	54 100.0%

2. Secondary Outcome

Title	Time to First Recurrence and Overall Survival
Description	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

Outcome Measure Data Not Reported

3. Other Pre-specified Outcome

Title	Improved Quality of Life
Description	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

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Adverse events experienced by subjects were collected from initiation of study device, throughout the study for up to 8 cycle of device use, and within 30 days of the last use of study device. Adverse events through 30 days after study completion were collected.
Adverse Event Reporting Description	Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses. No adverse event from non-cooling subjects since they did not use the device so they were not at risk.
Arm/Group Title	Scalp Cooling		Non-cooling
Arm/Group Description	Scalp Cooling PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap		Control Control No Treatment: No treatment to prevent hair loss
All-Cause Mortality
	Scalp Cooling		Non-cooling
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/137 (0.00%)		0/0
Serious Adverse Events
	Scalp Cooling		Non-cooling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/137 (0.00%)		0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Scalp Cooling		Non-cooling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/137 (28.47%)		0/0
Ear and labyrinth disorders
Ear pain † 1	1/137 (0.73%)	1	0/0	0
Gastrointestinal disorders
nausea † 1	7/137 (5.11%)	11	0/0	0
General disorders
chills † 1	1/137 (0.73%)	1	0/0	0
pain † 1	1/137 (0.73%)	1	0/0	0
Nervous system disorders
dizziness † 1	6/137 (4.38%)	7	0/0	0
headache † 1	27/137 (19.71%)	34	0/0	0
paresthesia † 1	1/137 (0.73%)	1	0/0	0
Sinus pain † 1	1/137 (0.73%)	1	0/0	0
Skin and subcutaneous tissue disorders
Dry skin † 1	3/137 (2.19%)	3	0/0	0
Pruritus † 1	2/137 (1.46%)	2	0/0	0
skin ulceration † 1	1/137 (0.73%)	1	0/0	0
scalp pain † 1	6/137 (4.38%)	7	0/0	0
1 Term from vocabulary, CTCAE (4.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Tao Wang
• Organization: Baylor College of Medicine
• Phone: 7137985388
• EMail: taow@bcm.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chevli N, Wang K, Haque W, Schwartz MR, Nangia J, Sasaki J, Farach AM, Hatch SS, Butler EB, Teh BS. Prognostic Impact of Radiation Therapy in Pure Mucinous Breast Carcinoma. Clin Breast Cancer. 2022 Oct;22(7):e807-e817. doi: 10.1016/j.clbc.2022.06.005. Epub 2022 Jul 7.

Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, Holmes F, Abraham J, Lacouture M, Courtright J, Paxman R, Rude M, Hilsenbeck S, Osborne CK, Rimawi M. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):596-605. doi: 10.1001/jama.2016.20939.

• Responsible Party: Julie Nangia, Baylor Breast Care Center
• ClinicalTrials.gov Identifier: NCT01986140
• Other Study ID Numbers: H: 33692 SCALP
• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Results First Submitted: July 13, 2018
• Results First Posted: October 16, 2018
• Last Update Posted: July 27, 2021