Clinical trial NCT03720015: Concurrent Training and Nutritional Management in Cancer
Official title: Concurrent Training and Nutritional Management Prevent Body Weight Loss During Radiotherapy in a Young Adult With Head and Neck Cancer: A Case Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 1
Sex: MALE
Minimum age (years): 32
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Case study
Primary purpose: PREVENTION

Brief summary: A case control study with before-after design. A concurrent training and a nutritional management intervention was offered by a patient with head and neck cancer, in order to compare outcomes related to strength and endurance performance and to body composition

Detailed description: Cancer causes important public health problems around the world and it is one of the most frequent cause of death overall. Among non-pharmacological treatment, physical exercise has shown improvements in different types of cancer and patients, but it is important to define the optimal dose. Our aim is to determine the effects of a concurrent training program and a nutritional management developed during radiotherapy treatment on physical performance and body composition. A patient with an oral cavity cancer will develop three sessions per week of concurrent training: resistance training included 9 standard exercises involving major muscle groups (4x8-12 RM), and cardiovascular training included a High-Intensity Interval Training (HIIT). Nutritional management will include a diet controlling macronutrients (\~4g/kg/day for carbohidrates, \~2g/kg/day for proteins, and \~1g/kg/day for fats), along with some nutritional supplements such as beta-hydroxybeta-methylbutyrate (HMB), arginine, glutamine, omega-3 fish oil concentrate, and BCAA's during training sessions. Intervention took place during radiotherapy period (7 weeks). We expect that body composition will remain invariable, and 1RM will increased. VO2max is expected to be almost the same, but intensity tolerated at maximum VO2max could be higher. If our results confirm that, we could conclude that a combination between resistance exercise and HIIT along with a nutritional management developed during radiotherapy could be effective to prevent muscle mass loss and muscle function decrease in a young patient with oral cavity cancer.

Eligibility criteria: This is a case control study

Primary outcomes:
measure: Body weight in kilograms (kg)
timeFrame: 8 weeks
measure: Total fat in percentage (%)
timeFrame: 8 weeks
measure: Lean body mass in percentage (%)
timeFrame: 8 weeks
measure: Visceral adipose tissue in cm2
timeFrame: 8 weeks
Secondary outcomes:
measure: 1 repetition maximal (1RM) for upper-body in kilograms (kg)
timeFrame: 8 weeks
measure: 1 repetition maximal (1RM) for lower-body in kilograms (kg)
timeFrame: 8 weeks
measure: Maximal oxygen uptake (VO2max) in ml/kg/min
timeFrame: 8 weeks
measure: Power at VO2max in watts (W)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Francisco de Vitoria University (UFV)
state: Madrid
Study officials:
References: