search
Back to results

Concurrent Training and Nutritional Management in Cancer

Primary Purpose

Body Weight Changes

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical exercise
Nutritional management
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight Changes

Eligibility Criteria

32 Years - 34 Years (Adult)MaleDoes not accept healthy volunteers
This is a case control study

Sites / Locations

  • Francisco de Vitoria University (UFV)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Concurrent training

Nutritional management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body weight in kilograms (kg)
Total fat in percentage (%)
Lean body mass in percentage (%)
Visceral adipose tissue in cm2

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2018
Last Updated
November 27, 2018
Sponsor
Universidad Francisco de Vitoria
search

1. Study Identification

Unique Protocol Identification Number
NCT03720015
Brief Title
Concurrent Training and Nutritional Management in Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
July 24, 2017 (Actual)
Study Completion Date
September 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Francisco de Vitoria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concurrent training
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutritional management
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Physical exercise
Intervention Description
Physical exercise controlled program supervised by an accredited exercise specialist
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional management
Intervention Description
Nutritional management controlled by a PhD clinical and sport nutrition specialist
Primary Outcome Measure Information:
Title
Body weight in kilograms (kg)
Time Frame
8 weeks
Title
Total fat in percentage (%)
Time Frame
8 weeks
Title
Lean body mass in percentage (%)
Time Frame
8 weeks
Title
Visceral adipose tissue in cm2
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
1 repetition maximal (1RM) for upper-body in kilograms (kg)
Description
Test will be performed in vertical bench press
Time Frame
8 weeks
Title
1 repetition maximal (1RM) for lower-body in kilograms (kg)
Description
Test will be performed in leg press
Time Frame
8 weeks
Title
Maximal oxygen uptake (VO2max) in ml/kg/min
Description
Test will be performed in a cycloergometer
Time Frame
8 weeks
Title
Power at VO2max in watts (W)
Description
Test will be performed in a cycloergometer
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
This is a case control study
Facility Information:
Facility Name
Francisco de Vitoria University (UFV)
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Concurrent Training and Nutritional Management in Cancer

We'll reach out to this number within 24 hrs