Neck CancerAPANVADSNCT01910753
Physical Activity Program and Nutrition Therapeutic Education During Treatment of Head and Neck Cancer Population
A study testing APA in people with Neck Cancer, run by University Hospital, Limoges at 2 sites in France.
Trial summary
The purpose of this study is to examine the feasibility of resistance training and physical functioning associated with nutrition therapeutic education in head and neck cancer patients, during their treatment (chemotherapy with or without radiotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Cancer
- What is being tested?
- APA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- May 2013to Jun 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Written informed consent provided before any study specific procedures
- Consent to cooperate for clinical assessments
- Affiliation to a social security regime or beneficiary of equivalent social protection
- Performance status between 0 and 2
- Squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
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- Stage III - IV (T1-T4, N0-N3, M)(UICC 2002)
- Indication of radiotherapy and chemotherapy post-operative or first-line metastatic chemotherapy or in inoperable condition
- Ability to understand the nature, goal and study methodology
Who cannot join
- Prior neoadjuvant chemotherapy
- timed vital capacity< 70%
- Presence of another severe pathology including:
- severe or chronic cardiac, pulmonary, renal and/or hepatic insufficiencies
- Cons-indication to physical activity practice, at discretion of the investigator
- Patient under guardianship
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- Psychological, social, geographical, or familial reasons prohibiting physical activity and follow-up
- Any other primary tumor during the last 5 years
- Pregnant or nursing
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU LIMOGES - Explorations Fonctionnelles Respiratoires
Limoges, Limoges, 87042
CHU LIMOGES - Oncologie
Limoges, 870
About this study
Official title: Feasibility Study: Physical Activity Program Associated Wtih Nutrition Therapeutic Education in Head and Neck Cancer Population Treating by Chemotherapy With or Without Radiotherapy.
The purpose of this study is to examine the feasibility of resistance training and physical functioning associated with nutrition therapeutic education in head and neck cancer patients, during their treatment (chemotherapy with or without radiotherapy).
Read the detailed description
The loss of muscle mass (i.e., sarcopenia) has been identified as a negative prognosis descriptor, disregarding the type of cancer. It is also a predictive descriptor for treatment-related toxicity. Therefore it appears crucial to save muscle mass of patients, following an adequate physical training together with a personalised diet program. The latter point is of major importance as malnutrition concerns 45% patients having head and neck cancer cancer, who stop physical activity due to extreme tiredness and decrease of quality of life. In the present project, we plan a physical activity program that would be adapted to each patient, accompanied by the rethought diet over a 3-month period. The adapted physical activity (APA) is constituted of two aerobic stages and one resistance training stage per a week. The evaluation will then proceed at three different moments, namely (i) at T0 i.e., beginning of the program, (ii) at 3 months i.e., when the program will be stopped, and (iii) at 6 months i.e., three months after the program stop. This evaluation will include the success rate, the level of satisfaction, the physiological parameters (VO2max, muscle mass and strength, BMI) and quality of life.
- Conditions
- Neck Cancer
- Being tested
- APA
- Keywords
- Head and neck cancer,, physical activity,, nutrition therapeutic education
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APAProcedure or surgery
A 3-month program for physical activity and diet education will be followed. An exercise specialist will supervise patients twice per week, during the first six weeks. They will also follow nutrition counselling and therapeutic education by a dietician once per week. During the last six weeks, they will just follow a guide for safe and appropriate exercise regimen. The dietician will call patient weekly during this final period.
| Study group | Role | What they receive |
|---|---|---|
| APA | Experimental | Patient with neck cancer and accepting the physical activity program . Receives: Procedure: APA |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of the APA with a composite outcome measure
The evaluation criteria for the PA program will be:
- The success rate that will be reached if 80% of physical exercises will be performed by the patient, over the 3-month period,
- The level of satisfaction that will be evaluated with questionnaires filled by the patient.
Measured: 3 months
Secondary outcomes (1)
Evaluation of the personalised diet program and the therapeutic education with a composite outcome measure.
The evaluation criteria for the personalised diet program and the therapeutic education will be:
- The success rate that will be reached if 80% of requirements will be addressed by the patient,
- The level of satisfaction that will be evaluated with questionnaires filled by the patient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRANCOIS Vincent, MD, Principal investigator, Limoges UHSabrina FALKOWSKI, MD, Principal investigator, CHU LIMOGES - Oncologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910753
- Sponsor's protocol ID
- I12018 APANVADS
- Acronym
- APANVADS
- Status last verified
- Sep 2016
- First submitted
- 22 Jul 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Physical Activity Program Associated Wtih Nutrition Therapeutic Education in Head and Neck Cancer Population Treating by Chemotherapy With or Without Radiotherapy.
- ClinicalTrials.gov ID
- NCT01910753
- Acronym / sponsor ID
- APANVADS / I12018 APANVADS
- Conditions
- Neck Cancer
- Keywords
- Head and neck cancer,, physical activity,, nutrition therapeutic education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- 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.
The purpose of this study is to examine the feasibility of resistance training and physical functioning associated with nutrition therapeutic education in head and neck cancer patients, during their treatment (chemotherapy with or without radiotherapy).
Detailed description
The loss of muscle mass (i.e., sarcopenia) has been identified as a negative prognosis descriptor, disregarding the type of cancer. It is also a predictive descriptor for treatment-related toxicity. Therefore it appears crucial to save muscle mass of patients, following an adequate physical training together with a personalised diet program. The latter point is of major importance as malnutrition concerns 45% patients having head and neck cancer cancer, who stop physical activity due to extreme tiredness and decrease of quality of life. In the present project, we plan a physical activity program that would be adapted to each patient, accompanied by the rethought diet over a 3-month period. The adapted physical activity (APA) is constituted of two aerobic stages and one resistance training stage per a week. The evaluation will then proceed at three different moments, namely (i) at T0 i.e., beginning of the program, (ii) at 3 months i.e., when the program will be stopped, and (iii) at 6 months i.e., three months after the program stop. This evaluation will include the success rate, the level of satisfaction, the physiological parameters (VO2max, muscle mass and strength, BMI) and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APA | Experimental | Procedure: APAPatient with neck cancer and accepting the physical activity program . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age>18 years
- Written informed consent provided before any study specific procedures
- Consent to cooperate for clinical assessments
- Affiliation to a social security regime or beneficiary of equivalent social protection
- Performance status between 0 and 2
Key exclusion criteria (9 listed)
- Prior neoadjuvant chemotherapy
- timed vital capacity< 70%
- Presence of another severe pathology including:
- severe or chronic cardiac, pulmonary, renal and/or hepatic insufficiencies
- Cons-indication to physical activity practice, at discretion of the investigator
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 |
|---|---|---|
| APAA 3-month program for physical activity and diet education will be followed. An exercise specialist will supervise patients twice per week, during the first six weeks. They will also follow nutrition counselling and therapeutic education by a dietician once per week. During the last six weeks, they will just follow a guide for safe and appropriate exercise regimen. The dietician will call patient weekly during this final period. | Procedure or surgery | APA |
Primary outcome
feasibility of the APA with a composite outcome measure
Time frame: 3 months
The evaluation criteria for the PA program will be: * The success rate that will be reached if 80% of physical exercises will be performed by the patient, over the 3-month period, * The level of satisfaction that will be evaluated with questionnaires filled by the patient.
1 secondary outcome
Evaluation of the personalised diet program and the therapeutic education with a composite outcome measure.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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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.
FRANCOIS Vincent, MD principal investigator
Limoges UH
Sabrina FALKOWSKI, MD principal investigator
CHU LIMOGES - Oncologie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA in people with Neck Cancer, run by University Hospital, Limoges at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. 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: stopped early, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: Not enough patients). Results are not available in the source record.
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?
feasibility of the APA with a composite outcome measure (time frame: 3 months). 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 7 Sep 2016.