Concurrent Training and Nutritional Management in Cancer

Concurrent Training and Nutritional Management Prevent Body Weight Loss During Radiotherapy in a Young Adult With Head and Neck Cancer: A Case Control Study

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

Study Overview

• Status: Completed
• Conditions: Body Weight Changes
• Intervention / Treatment: Behavioral: Physical exercise; Dietary supplement: Nutritional management

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Pozuelo De Alarcón, Madrid, Spain, 28223
      • Francisco de Vitoria University (UFV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 32 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

This is a case control study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concurrent training; Three sessions per week of concurrent training during radiotherapy period. Each session will begin with warm-up (5-min cardiovascular activity at low-moderate intensity, joint mobility and one set of resistance exercises circuit at 30-40% 1RM). Resistance training will follow the warm-up, including 9 standard exercises involving major muscle groups of the lower and upper body: vertical bench press, parallel bar dip for triceps, seated rowing, standing dumbbell curl for biceps, leg press, deadlift and shoulder press. All these exercises will be realized following circuit training with 4 sets of 8-12 repetitions, using a training load of 70-80% RM. When patient will able to complete more than 12 repetitions, load will be increased progressively 10%. Cardiovascular training will be completed 20-30 min after resistance training, and it will include High-Intensity Interval Training (HIIT) of 3 min near to the second ventilatory threshold and 2 min near to the first ventilatory threshold.	Behavioral: Physical exercise; Physical exercise controlled program supervised by an accredited exercise specialist
Experimental: Nutritional management; Prescribed diet controlling macronutrients according to patient body weight (~4g/kg/day for carbohidrates, ~2g/kg/day for proteins, and ~1g/kg/day for fats). Patient will take one single dosage per day of probiotics (Arkoprobiotics® Defenses), 1 or 2 capsules of omega-3 fish oil concentrate (Solgar®, 600-1200mg depending on fat sources intake during the day), and a combine ingestion of 3g beta-hydroxybeta-methylbutyrate (HMB), 14g arginine, and 14g glutamine (HSN Raw Series®, all pure ingredients and making the ingestion adding each of them individually in a solution with 300-400 ml of water). During concurrent training sessions, between resistance exercise and HIIT, patient will also take 6g of BCAA's (HSN Raw Series®, 2:1:1) along with a banana. Additionally, patient could take whey isolated protein (Amix® IsoPrime CFM) to meet with some of the prescribed proteins intakes.	Dietary supplement: Nutritional management; Nutritional management controlled by a PhD clinical and sport nutrition specialist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight in kilograms (kg)	8 weeks
Total fat in percentage (%)	8 weeks
Lean body mass in percentage (%)	8 weeks
Visceral adipose tissue in cm2	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 repetition maximal (1RM) for upper-body in kilograms (kg)	Test will be performed in vertical bench press	8 weeks
1 repetition maximal (1RM) for lower-body in kilograms (kg)	Test will be performed in leg press	8 weeks
Maximal oxygen uptake (VO2max) in ml/kg/min	Test will be performed in a cycloergometer	8 weeks
Power at VO2max in watts (W)	Test will be performed in a cycloergometer	8 weeks

Collaborators and Investigators

• Sponsor: Universidad Francisco de Vitoria

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): July 24, 2017
• Study Completion (Actual): September 17, 2017

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: 0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No