Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol

Figures & data

Table 1 Baseline participant characteristics

Characteristics	Biomarker dataa	No post-treatment biomarker data	p-value
	Number (%)	Number (%)
Total	155 (100)	81 (100)
Age–median (range)	52.0 (28–72)	50.7 (33–85)	0.529
BMIb			0.425
Underweight-normal (<25)	52 (34)	21 (26)
Overweight (25–30)	46 (30)	25 (31)
Obese (30+)	56 (36)	35 (43)
Race/ethnicity			0.401
Hispanic	4 (3)	0 (0)
Black	16 (10)	10 (12)
White	135 (87)	71 (88)
Performance status			0.498
0	139 (90)	76 (94)
1	15 (10)	5 (6)
2	1 (1)	0 (0)
Strata			0.974
Anthracycline+RT	79 (51)	41 (51)
Anthracycline and no RT	50 (32)	28 (35)
Nonanthracycline+RT	17 (11)	8 (10)
Nonanthracycline and no RT	9 (6)	4 (5)
Alpha-tocopherol (N)	154	34c
μg/mL Mean (SD)	14.1 (8.8)	12.6 (7.5)	0.348
CoQ10 (N)	147	26c
μg/mL Mean (SD)	0.73 (0.33)	0.66 (0.26)	0.271
Drop out early	23 (15)	74 (91)	<0.001

Note:

a Baseline and post-treatment alpha-tocopherol and/or CoQ10 data;

b one value missing;

c no post-treatment biomarker data.

Abbreviations: BMI, body mass index; CoQ10, coenzyme Q10; RT, radiation therapy.

Figure 1 Self-reported adherence at 8, 12, and 24 weeks for each adherence definition.

Notes: Definition 1: excludes missing days; Definition 2: includes missing days in returned diaries as zeros; Definition 3: same as Definition 2 but also includes missing diaries as zeros.

Table 2 Self-reported adherence of participants providing biomarker data using 3 different definitions of adherencea

Outcomes	Mean (SD)	Median (range)
Number of diary days returned
Excluding missing days	142.7 (41.1)	149 (1–168)
Including missing days for returned diaries as zeros	152.6 (35.8)	168 (7–168)
Adherence (first 8 weeks)
1) Excluding missing days	91.9 (10.0)	95.8 (43–100)
2) Including missing days for returned diaries as zeros	85.8 (17.2)	92.3 (19–100)
3) As (2) but also including missing diaries as zeros	80.6 (26.5)	91.7 (0–100)
Adherence (first 16 weeks)
1) Excluding missing days	91.5 (10.2)	94.9 (40–100)
2) Including missing days for returned diaries as zeros	84.3 (17.9)	90.5 (19–100)
3) As (2) but also including missing diaries as zeros	77.3 (28.8)	89.9 (0–100)
Adherence (first 24 weeks)
1) Excluding missing days	91.3 (10.3)	94.8 (48–100)
2) Including missing days for returned diaries as zeros	83.6 (17.5)	89.7 (19–100)
3) As (2) but also including missing diaries as zeros	74.2 (30.1)	87.5 (0–100)

Notes:

a 147/155 participants with biomarker data (95%) returned at least 1 diary. Overall, 209/236 participants (89%) returned at least 1 diary.

Figure 2 Change in baseline in levels of CoQ10 and Alpha-Tochopherol at 8, 16, and 24 weeks.

Figure 3 Change in CoQ10 versus change in Alpha-Tochopherol at 8, 16 and 24 weeks in the CoQ10 intervention arm.

Abbreviation: CoQ10, coenzyme Q10.

Table 3A Correlation between biomarker changes and self-reported adherence

Biomarker	Period	Self-reported adherence, n, correlation (p-value)
		Definition 1a	Definition 2a	Definition 3a
Pearson correlation coefficients
Δ in	First 8 weeks	145, 0.208 (0.012)	145, 0.219 (0.008)	152, 0.282 (<0.001)
alpha-tocopherol	First 16 weeks	127, 0.058 (0.519)	127, 0.113 (0.207)	132, 0.186 (0.032)
	First 24 weeks	124, 0.102 (0.261)	124, 0.151 (0.094)	129, 0.196 (0.026)
Δ in	First 8 weeks	72, 0.256 (0.030)	72, 0.319 (0.006)	76, 0.402 (<0.001)
CoQ10b	First 16 weeks	65, 0.136 (0.281)	65, 0.153 (0.223)	68, 0.287 (0.018)
	First 24 weeks	70, 0.095 (0.435)	70, 0.168 (0.164)	72, 0.243 (0.040)
Spearman correlation coefficients
Δ in	First 8 weeks	145, 0.214 (0.010)	145, 0.263 (0.001)	152, 0.327 (<0.001)
alpha-tocopherol	First 16 weeks	127, 0.070 (0.431)	127, 0.105 (0.240)	132, 0.146 (0.095)
	First 24 weeks	124, 0.094 (0.298)	124, 0.0767 (0.394)	129, 0.112 (0.207)
Δ in	First 8 weeks	72, 0.181 (0.129)	72, 0.288 (0.014)	76, 0.358 (0.002)
CoQ10b	First 16 weeks	65, 0.084 (0.506)	65, 0.034 (0.788)	68, 0.133 (0.281)
	First 24 weeks	70, 0.045 (0.714)	70, 0.138 (0.254)	72, 0.208 (0.079)

Notes:

a Definition 1 – excludes missing days. Definition 2 – includes missing days for returned diaries as zeros. Definition 3 is same as definition 2 but also includes missing diaries as zeros.

b CoQ10 intervention group participants only.

Abbreviation: CoQ10, coenzyme Q10.

Table 3B Correlation between biomarker changes and self-reported adherence 1 and 2 weeks prior to blood draw

Biomarker	Period	Self-reported adherence, n, Pearson correlation (p-value)
		Definition 1a	Definition 2a	Definition 3a
One week
Δ in	First 8 weeks	138, 0.158 (0.064)	139, 0.089 (0.300)	152, 0.261 (0.001)
alpha-tocopherol	First 16 weeks	118, 0.040 (0.667)	119, 0.115 (0.214)	132, 0.211 (0.015)
	First 24 weeks	91, 0.083 (0.434)	95, 0.138 (0.183)	129, 0.144 (0.104)
Δ in	First 8 weeks	69, 0.201 (0.098)	69, 0.243 (0.044)	76, 0.425 (<0.001)
CoQ10b	First 16 weeks	62, 0.134 (0.299)	62, 0.003 (0.979)	68, 0.263 (0.031)
	First 24 weeks	49, 0.043 (0.770)	53, 0.236 (0.088)	72, 0.390 (0.001)
Two weeks
Δ in	First 8 weeks	138, 0.194 (0.022)	139, 0.138 (0.105)	152, 0.296 (<0.001)
alpha-tocopherol	First 16 weeks	120, 0.005 (0.959)	122, 0.123 (0.176)	132, 0.201 (0.021)
	First 24 weeks	101, 0.097 (0.334)	101, 0.143 (0.153)	129, 0.154 (0.082)
Δ in	First 8 weeks	69, 0.243 (0.044)	69, 0.241 (0.046)	76, 0.412 (<0.001)
CoQ10b	First 16 weeks	63, 0.178 (0.163)	63, 0.060 (0.639)	68, 0.276 (0.023)
	First 24 weeks	55, 0.088 (0.525)	55, 0.237 (0.082)	72, 0.463 (<0.001)

Notes:

a Definition 1 – excludes missing days. Definition 2 – includes missing days for returned diaries as zeros. Definition 3 is same as definition 2 but also includes missing diaries as zeros.

b CoQ10 intervention group participants only.

Abbreviation: CoQ10, coenzyme Q10.

Figure 4 Change in Alpha-Tocopherol and CoQ10 versus self-reported adherence.

Abbreviation: CoQ10, coenzyme Q10.

Table 4 Change in alpha-tocopherol and CoQ10 levels by self-reported adherence

Outcome	Self-reported adherencea, mean change (SD)			p-value
	Low (≤60%)	Intermediate (60%–90%)	High (90%–100%)
First 8 weeks (N)	21	51	80
Change in alpha-tocopherol	2.42 (10.9)	7.62 (7.46)	13.5 (14.4)	<0.001
First 16 weeks (N)	19	42	71
Change in alpha-tocopherol	5.60 (8.99)	10.4 (9.77)	11.5 (15.4)	0.179
First 24 weeks (N)	17	43	69
Change in alpha-tocopherol	1.90 (8.27)	8.12 (7.62)	9.03 (14.0)	0.033
First 8 weeks	10	28	38
Change in CoQ10b	0.40 (0.42)	1.68 (1.15)	1.73 (0.87)	<0.001
First 16 weeks	9	21	38
Change in CoQ10b	0.53 (0.69)	2.03 (1.33)	1.79 (1.39)	0.005
First 24 weeks	8	27	37
Change in CoQ10b	0.27 (0.26)	1.22 (1.15)	1.22 (1.21)	0.023

Notes:

a Definition 3 – includes missing days for returned diaries as zeros and missing diaries as zeros.

b CoQ10 intervention group participants only.

Abbreviation: CoQ10, coenzyme Q10.