Abstract 918P
Background
Locally advanced head and neck cancer (HNC) treatment promote toxicities that compromise patient’s quality of life (QoL) and treatment efficacy. Exercise training (ET) benefits are reported for many cancer types. To study this supportive care strategy in HNC patients, we designed a two-phase research project: 1) prospective observational cohort study to analyze treatment toxicities and ET preferences; 2) randomized-controlled trial to test an ET program (FIT4TREAT). Here we present the results of phase I.
Methods
Planned enrollment was 20 patients with stage III/IV HNC proposed for multimodal treatment with curative intent. Patients were assessed in 3 moments: baseline (M0), at the end of treatment (M1) and at 4 months follow-up (M2). Primary endpoint was QoL, evaluated by EORTC QLQ-C30 questionnaire. Secondary endpoints: dysphagia (EAT-10, FOIS), nutritional status (PG-SGA), cognitive function (MoCA), handgrip strength and 6-minute walk test (6MWT). Due to COVID-19 pandemic the study was suspended in March 2020. Comparative analysis (M0 vs M1) took in consideration 7 patients submitted to radical chemoradiotherapy (CRT).
Results
From June 2019 to March 2020, 21 patients were recruited (95% men, median age 54 years). The majority recognized the health benefits of an ET program. Most patients were willing to participate in an ET program before (33%), during (52%) and/or after (67%) treatment. The most common exercise preferences were a frequency of 2 times/week, low intensity, 15-30 min/bout. The table shows the acute impact of radical CRT (n=7). Table: 918P
| M0 Median (IQR) | M1 Median (IQR) | p-value | |
| Global QoL (score) | 75 (66.7 – 83.3) | 50 (33.3 – 66.7) | 0.017 |
| Social function (score) | 100 | 66.7 (66.7 – 100) | 0.046 |
| Fatigue (score) | 11 (0 – 33.3) | 44.4 (33.3 – 77.8) | 0.026 |
| Pain (score) | 16.7 (16.7 – 33.3) | 33.3 (0 – 33.3) | 0.038 |
| Handgrip strength - dominant (kgf) | 39.7 (35.0 – 50.0) | 35 (31.7 – 39.3) | 0.018 |
| Handgrip strength - non dominant (kgf) | 37.2 (34.3 – 41.2) | 33 (31.7 – 37.9) | 0.043 |
| 6MWT (meters) | 486 (412 - 533) | 422 (362 - 510) | 0.018 |
| FOIS (score) | 6 (5 - 7) | 4 (1 - 5) | 0.041 |
| EAT-10 (score) | 7 (0 – 11) | 31 (21 - 40) | 0.027 |
| PG-SGA global (score) | 7 (3.3 – 12.8) | 18 (15 – 23.3) | 0.028 |
| Body mass index (kg/m2) | 20.9 (12.0 – 25,8) | 15.3 (11.8 – 20.3) | 0.028 |
| MoCA (score) | 26 (20 - 27) | 23 (20 - 26) | 0.167 |
Conclusions
HNC patients are a vulnerable population. Radical CRT declines QoL, physical and nutritional status. These results encouraged the development of ET program FIT4TREAT, which will start recruiting during 2021. We expect to optimize patients’ physical fitness and achieve more efficacy with less toxicity.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.