Concurrent Training and Nutritional Management in Cancer

Sponsor

Universidad Francisco de Vitoria (Other)

Overall Status

Completed

CT.gov ID

NCT03720015

Collaborator

(none)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Body Weight Changes	Behavioral: Physical exercise Dietary Supplement: Nutritional management	N/A

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

Actual Enrollment :

1 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Case studyCase study

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jul 20, 2017

Actual Primary Completion Date :

Jul 24, 2017

Actual Study Completion Date :

Sep 17, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Years to 34 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

This is a case control study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Francisco de Vitoria University (UFV)	Pozuelo De Alarcón	Madrid	Spain	28223

Sponsors and Collaborators

Universidad Francisco de Vitoria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luis Berlanga, Principal Investigator, Universidad Francisco de Vitoria

ClinicalTrials.gov Identifier:

NCT03720015

Other Study ID Numbers:

0003

First Posted:

Oct 25, 2018

Last Update Posted:

Nov 29, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Body Weight

Body Weight Changes

Study Results

No Results Posted as of Nov 29, 2018