Concurrent Training and Nutritional Management in Cancer

Body Weight Changes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720015
• Other study ID #: 0003
• Status: Completed
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: September 17, 2017

Study information

• Verified date: November 2018
• Source: Universidad Francisco de Vitoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 17, 2017
• Est. primary completion date: July 24, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 32 Years to 34 Years
• Eligibility: This is a case control study

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes

Intervention

Behavioral:
• Physical exercise
Physical exercise controlled program supervised by an accredited exercise specialist

Dietary Supplement:
• Nutritional management
Nutritional management controlled by a PhD clinical and sport nutrition specialist

Locations

Country	Name	City	State
Spain	Francisco de Vitoria University (UFV)	Pozuelo De Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight in kilograms (kg)		8 weeks
Primary	Total fat in percentage (%)		8 weeks
Primary	Lean body mass in percentage (%)		8 weeks
Primary	Visceral adipose tissue in cm2		8 weeks
Secondary	1 repetition maximal (1RM) for upper-body in kilograms (kg)	Test will be performed in vertical bench press	8 weeks
Secondary	1 repetition maximal (1RM) for lower-body in kilograms (kg)	Test will be performed in leg press	8 weeks
Secondary	Maximal oxygen uptake (VO2max) in ml/kg/min	Test will be performed in a cycloergometer	8 weeks
Secondary	Power at VO2max in watts (W)	Test will be performed in a cycloergometer	8 weeks