Effect of Heparinoid Moisturizer on Quality of Life in Patients with Acute Radiation Skin Damage Following Hypofractionated Radiation Therapy After Breast-Conserving Surgery: A Randomized Controlled Study

Figures & data

Figure 1 Study Design. ^†Moisturizer was instructed to apply approximately 0.5g in accordance with finger-tip unit on their irradiated skin twice daily.

Abbreviations: Group M, moisturizer group; Group C, control group; DLQI, Dermatology Life Quality Index.

Table 1 Patients’ Characteristics

	Group M (n=35)	Group C (n=37)
Age (years, mean ± SD)	57.3 ± 9.0	56.2 ± 10.0
BMI (kg/m^2, mean ± SD)	22.1 ± 3.5	22.0 ± 4.3
Current/Experienced Smoker	2/6 (5.7%/17.1%)	1/7 (2.7%/18.9%)
Chemotherapy	7 (20.0%)	9 (24.3%)
Boost	7 (20.0%)	10 (27.0%)
RNI (Level I)	2 (5.7%)	1 (2.7%)
Deep Inspiration Breath Hold	2 (5.7%)	1 (2.7%)
CTV (cc, mean ± SD)	449.3 ± 198.5	471.3 ± 292.7
Source 4MV/6MV-Photon	28 (80.0%)/7 (20.0%)	28 (75.7%)/9 (24.3%)
V105 (cc, mean ± SD)	11.65 ± 14.67	7.74 ± 12.24
Dmax (cGy, mean ± SD)	4502.9 ± 61.7	4500.0 ± 39.7

Abbreviations: BMI, body mass index; RNI, Regional Nodal Irradiation; CTV, clinical target volume; V₁₀₅, breast volume receiving more than 105% of the prescribed dose; D_max, maximum dose of irradiated breast.

Figure 2 Patients flow.

Abbreviations: Group M, moisturizer group; Group C, control group.

Table 2 Maximum CTCAE Radiation Dermatitis Grade During the Observation Interval

CTCAE Grade	Grade 1	Grade 2
Group M (n = 35)	33 (0*)	2 (1*)
Group C (n = 37)	35 (1*)	2 (2*)

Note: *Number of patients who received steroid treatment.

Abbreviation: CTCAE, Common Terminology Criteria for Adverse Events.

Table 3 Time Course of CTCAE Radiation Dermatitis Grade During the Observation Interval

After the Start of Irradiation	1 Week	2 Weeks	3 Weeks	4 Weeks	5 Weeks	7 Weeks
Group M (n = 35) Grade 0/Grade 1/Grade 2	23/12/0	10/25/0	1/34/0	1/32/2	1/33/0	1/33/0
Group C (n = 37) Grade 0/Grade 1/Grade 2	28/9/0	12/25/0	4/23/0	3/32/2	2/33/1	4/31/0

Abbreviation: CTCAE, Common Terminology Criteria for Adverse Events.

Table 4 DLQI Total Score (DLQI: Dermatology Life Quality Index)

(A) Group M vs Group C at each time point
	Group M			Group C		p value
	n	Mean ± SD		n	Mean ± SD
Start date	34	0.77 ± 1.26		33	0.91 ± 1.96	0.619
1 week	32	1.25 ± 2.02		33	1.24 ± 2.09	0.888
2 weeks	32	1.19 ± 1.33		29	1.38 ± 1.68	0.777
3 weeks	31	1.55 ± 1.90		29	2.62 ± 3.19	0.142
4 weeks	32	2.06 ± 2.17		32	2.16 ± 2.13	0.894
5 weeks	32	1.97 ± 2.31		31	2.45 ± 2.46	0.412
7 weeks	32	1.09 ± 1.00		30	1.63 ± 1.87	0.321
(B) Start date vs 1, 2, 3, 4, 5 and 7 weeks
	Group M			Group C
	n	Mean ± SD	p value	n	Mean ± SD	p value
Start date	31	0.71 ± 1.30		31	0.97 ± 2.01
1 week	31	1.26 ± 2.05	1.000	31	1.32 ± 2.14	0.873
2 weeks	31	1.19 ± 1.35	0.599	27	1.41 ± 1.74	0.164
3 weeks	31	1.55 ± 1.90	0.035*	28	2.71 ± 3.21	0.003*
4 weeks	32	2.06 ± 2.17	<0.001*	30	2.23 ± 2.16	0.007*
5 weeks	32	1.97 ± 2.31	0.006*	29	2.55 ± 2.50	0.011*
7 weeks	32	1.09 ± 1.00	1.000	28	1.68 ± 1.93	0.158

Notes: Bold: Primary endpoint, Mann–Whitney U-test. Wilcoxon signed-rank test with Bonferroni correction, *p<0.05.

Abbreviation: SD, standard deviation.

Figure 3 DLQI total score and subscore (mean ± SD), (A) At start date, (B) At 4 weeks. The boxes indicate 25th and 75th percentiles of the score, while the “x” within the boxes indicates the mean. Error bars show the maximum and minimum values.

Abbreviations: Group M, moisturizer group; Group C, control group; DLQI, Dermatology Life Quality Index; SD, standard deviation.

Table 5 DLQI (Dermatology Life Quality Index) Symptoms/Feelings Subscore

(A) Group M vs Group C at Each Time Point
	Group M			Group C
	n	Mean ± SD		n	Mean ± SD	p value
Start date	35	0.49 ± 0.74		37	0.32 ± 0.48	0.512
1 week	35	0.54 ± 0.70		37	0.49 ± 0.61	0.827
2 weeks	35	0.60 ± 0.50		37	0.68 ± 0.71	0.893
3 weeks	34	0.79 ± 0.54		35	1.00 ± 0.84	0.355
4 weeks	33	1.06 ± 0.70		34	1.06 ± 0.74	0.988
5 weeks	33	1.09 ± 0.77		34	1.15 ± 0.82	0.739
7 weeks	33	0.76 ± 0.56		34	0.88 ± 0.64	0.433
(B) Start Date vs 1, 2, 3, 4, 5 and 7 Weeks
	Group M			Group C
	n	Mean ± SD	p value	n	Mean ± SD	p value
Start date	35	0.49 ± 0.74		37	0.32 ± 0.48
1 week	35	0.54 ± 0.70	1.000	37	0.49 ± 0.61	1.000
2 weeks	35	0.60 ± 0.50	1.000	37	0.68 ± 0.71	0.111
3 weeks	34	0.79 ± 0.54	0.082	35	1.00 ± 0.84	0.004*
4 weeks	33	1.06 ± 0.70	0.006*	34	1.06 ± 0.74	0.001*
5 weeks	33	1.09 ± 0.77	0.016*	34	1.15 ± 0.82	0.001*
7 weeks	33	0.76 ± 0.56	0.447	34	0.88±0.64	0.007*

Note: Mann–Whitney U-test, Wilcoxon signed-rank test with Bonferroni correction, *p<0.05.

Abbreviation: SD, standard deviation.

Figure 4 Time-course in DLQI (mean ± SD). (A) DLQI total score, (B) Symptoms and Feelings subscore, Wilcoxon signed-rank test with Bonferroni, ^†p<0.05 *p<0.05.

Abbreviations: Group M, moisturizer group; Group C, control group; DLQI, Dermatology Life Quality Index; SD, standard deviation.