Body Weight ChangesNCT03720015
Concurrent Training and Nutritional Management in Cancer
A study testing Physical exercise and Nutritional management in people with Body Weight Changes, run by Universidad Francisco de Vitoria at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 32 to 34 years, men only
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Physical exercise and Nutritional management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2017to 17 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 34 years
- Men only
- No healthy volunteers
- Adult
This is a case control study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Francisco de Vitoria University (UFV)
Pozuelo de Alarcón, Madrid, 28223
About this study
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
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
Read the 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.
- Conditions
- Body Weight Changes
- Being tested
- Physical exercise, Nutritional management
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
Physical exercise controlled program supervised by an accredited exercise specialist
Nutritional managementDietary supplement
Nutritional management controlled by a PhD clinical and sport nutrition specialist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical exercise |
| 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. Receives: Dietary Supplement: Nutritional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight in kilograms (kg)
Measured: 8 weeks
Total fat in percentage (%)
Measured: 8 weeks
Lean body mass in percentage (%)
Measured: 8 weeks
Visceral adipose tissue in cm2
Measured: 8 weeks
Secondary outcomes (4)
1 repetition maximal (1RM) for upper-body in kilograms (kg)
Test will be performed in vertical bench press
Measured: 8 weeks
1 repetition maximal (1RM) for lower-body in kilograms (kg)
Test will be performed in leg press
Measured: 8 weeks
Maximal oxygen uptake (VO2max) in ml/kg/min
Test will be performed in a cycloergometer
Measured: 8 weeks
Power at VO2max in watts (W)
Test will be performed in a cycloergometer
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start20 Jul 2017
- Primary completion24 Jul 2017
- Study completion17 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Case study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Berlanga, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720015
- Sponsor's protocol ID
- 0003
- Status last verified
- Nov 2018
- First submitted
- 16 Oct 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03720015
- Acronym / sponsor ID
- 0003
- Conditions
- Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 17 Sep 2017 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case study
| Arm | Type | Receives |
|---|---|---|
| Concurrent training | Experimental | Behavioral: Physical exerciseThree 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. |
| Nutritional management | Experimental | Dietary Supplement: Nutritional managementPrescribed 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. |
Who may qualify
- Ages
- 32 to 34 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercisePhysical exercise controlled program supervised by an accredited exercise specialist | Behavioural | Concurrent training |
| Nutritional managementNutritional management controlled by a PhD clinical and sport nutrition specialist | Dietary supplement | Nutritional management |
Primary outcome
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
4 secondary outcomes
1 repetition maximal (1RM) for upper-body in kilograms (kg)
Time frame: 8 weeks
1 repetition maximal (1RM) for lower-body in kilograms (kg)
Time frame: 8 weeks
Maximal oxygen uptake (VO2max) in ml/kg/min
Time frame: 8 weeks
Power at VO2max in watts (W)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and Nutritional management in people with Body Weight Changes, run by Universidad Francisco de Vitoria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight in kilograms (kg) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.