Early preventive exercises versus usual care does not seem to reduce trismus in patients treated with radiotherapy for cancer in the oral cavity or oropharynx: A randomised clinical trial

Figures & data

Figure 1. CONSORT diagram. Enrollment of patients and number of patients participating in baseline and follow-up assessment.

Table I. Baseline characteristics at entry into the trial.

	Intervention group	Usual care group
Characteristic	N = 50	N = 47
Age, mean (SD), yr.	58.6 (8.6)	58.5 (10.7)
Female, N (%)	13 (26)	14 (30)
Comorbidity, Charlson Index*, mean (SD)	3.38 (1.4)	2.91 (0.2)
Cancer site
Oral cavity, N (%)	8 (16)	12 (26)
Oropharynx, N (%)	42 (84)	35 (74)
Tumour size
T3-T4, N (%)	24 (48)	15 (32)
Nodal stage
N0, N	9	9
N+, N	41	38
Radiotherapy dose 66–70, mean (SD), Gy	67.2 (1.1)	66.8 (1.0)
5 weekly fractions, N	4	1
6 weekly fractions, N	46	46
IMRT, N	46	41
CRT, N	4	6
cCHT, N	36	30
EGFr, N	8	5
Small surgery, N	8	10
Smoker, N (%)	16 (32)	13 (28)
Alcohol intake, mean (SD) – alcohol drink/week	14.9 (18.1)	12.9 (13.5)
BMI, mean (SD) kg/m^2	25.5 (5.6)	24.3 (4.4)
Work status
At work, N	10	7
Sick leave, N	17	18
Retired, N	23	22
Marital status
Living together, N (%)	21 (42)	30 (64)

*Charlson Index, Comorbidity score added to age score.

cCHT, concomitant chemotherapy; CRT, conventional radiation therapy; EGFr, epidermal growth factor receptor; IMRT, intensity-modulated radiation therapy.

Figure 2. Mean maximal mouth opening (MID) in mm with standard error of the mean (error bars) over time according to treatment group. Measurements are shown for all patients (Panel A), those with less severe tumour size T1–T2 (Panel B) and those with more severe tumour size T3–T4 (Panel C).