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Clinical Trials/NCT03720015
NCT03720015CompletedNot Applicable

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

Universidad Francisco de Vitoria1 site in 1 country1 target enrollmentStarted: July 20, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1
Locations
1
Primary Endpoint
Body weight in kilograms (kg)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
32 Years to 34 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •This is a case control study

Exclusion Criteria

  • Not provided

Arms & Interventions

Concurrent training

Experimental

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.

Intervention: Physical exercise (Behavioral)

Nutritional management

Experimental

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.

Intervention: Nutritional management (Dietary Supplement)

Outcomes

Primary Outcomes

Body weight in kilograms (kg)

Time Frame: 8 weeks

Total fat in percentage (%)

Time Frame: 8 weeks

Lean body mass in percentage (%)

Time Frame: 8 weeks

Visceral adipose tissue in cm2

Time Frame: 8 weeks

Secondary Outcomes

  • Maximal oxygen uptake (VO2max) in ml/kg/min(8 weeks)
  • 1 repetition maximal (1RM) for upper-body in kilograms (kg)(8 weeks)
  • 1 repetition maximal (1RM) for lower-body in kilograms (kg)(8 weeks)
  • Power at VO2max in watts (W)(8 weeks)

Investigators

Sponsor
Universidad Francisco de Vitoria
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Luis Berlanga

Principal Investigator

Universidad Francisco de Vitoria

Study Sites (1)

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