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Completed

NCT Number: NCT03720015

Concurrent Training and Nutritional Management in Cancer

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

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Key information

Age range

32 year–34 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Francisco de Vitoria University (UFV)

Pozuelo de Alarcón, Madrid, 28223, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

This is a case control study

Treatment and study plan

Physical exercise

Behavioral

Physical exercise controlled program supervised by an accredited exercise specialist

Nutritional management

Dietary Supplement

Nutritional management controlled by a PhD clinical and sport nutrition specialist

Primary outcomes

  1. Body weight in kilograms (kg)

    Time frame: 8 weeks

  2. Total fat in percentage (%)

    Time frame: 8 weeks

  3. Lean body mass in percentage (%)

    Time frame: 8 weeks

  4. Visceral adipose tissue in cm2

    Time frame: 8 weeks

Secondary outcomes

  1. 1 repetition maximal (1RM) for upper-body in kilograms (kg)

    Time frame: 8 weeks

    Test will be performed in vertical bench press

  2. 1 repetition maximal (1RM) for lower-body in kilograms (kg)

    Time frame: 8 weeks

    Test will be performed in leg press

  3. Maximal oxygen uptake (VO2max) in ml/kg/min

    Time frame: 8 weeks

    Test will be performed in a cycloergometer

  4. Power at VO2max in watts (W)

    Time frame: 8 weeks

    Test will be performed in a cycloergometer

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2018
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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