Head and Neck CancerNUQUE3NCT02789267
Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
A study testing Regular dietary support in people with Head and Neck Cancer, run by University Hospital, Caen at 1 site in France.
Trial summary
Undernutrition in cancerology is frequent because it's present for thirty to fifty percent of the patients at the time of the diagnosis. According to the recommendations of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five percent loss of weight compared to the previous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Regular dietary support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2016to 1 Mar 2018
- 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
- patients with first head and neck cancer histologically proved
- treatment by radiotherapy
- no sign of recidive
- life expectancy 3-month-old superior
- OMS score < 3
- french speaking
Who cannot join
- other former cancer
- pregnant woman
- no oral feeding before radiotherapy
- uncontrolled infectious pathology
Trial locations and contacts
1 site in 1 country.
About this study
Undernutrition in cancerology is frequent because it's present for thirty to fifty percent of the patients at the time of the diagnosis. According to the recommendations of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five percent loss of weight compared to the previous weight increases the risk of toxicity of the chemotherapy and worsens the patient's quality of life.
The treatment of the tumors of the head and the neck comes along very often with a loss of weight (17.4 % after one year of radiotherapy according to the study of Larsson et al.) which varies with the chosen treatment, and shows a major risk at the patients whose therapeutic sequence involves a radiotherapy. The irradiation of the upper aerodigestive tract is source of aftereffects and late complications: xerostomia, oedemas of mucous membranes.
Read more
The xerostomia, connected to the damage of the salivary glands, is a frequent complaint of the patients. It reveals or even increases, a dysphagia. According to Woisard, six months after the end of treatments, forty percent of the patients suffer from a dysphagia.
All these complications limit quantitatively and qualitatively the food intake. The adaptation of the texture of the food is necessary by fifty four percent at three months of the end of treatments according to Logemann et al., and a few patients remain dependent on an long term enteral nutrition.
Beyond a change of the nutritional state, the feeding difficulties or even the absence of resumption of an oral feeding are responsible for a social isolation. The meal which lost its dimension of pleasure becomes a source of fear and obsession for the patient as well as for his relations, and this fact generates family tensions. The quality of life of the patient is heavily affected.
Ravasco showed in his study that the impact on the nutritional state of a nutritional care by dietary advices was more important as the prescription of oral nutritional supplements but based on a short period (the dietary intervention covered only the duration of the radiotherapy). But what would happen after the end of treatments? The investigators emit the hypothesis that a post-therapeutic systematic and regular dietary support has a positive impact on the prevention of the undernutrition among the patients affected by a first cancer of the upper aerodigestive tract whom therapeutic sequence involves a radiotherapy.
Read the detailed description
The investigators propose a prospective randomized, open and multicentric study. This study has to include 224 patients affected by a head and neck cancer which therapeutic sequence involves a more or less made sensitized radiotherapy. The beginning of the inclusions is planned for May 2016, the end of inclusion 36 months later.
The nutritional state and quality of life will be evaluated 6 months after radiotherapy.
- Conditions
- Head and Neck Cancer
- Being tested
- Regular dietary support
- Keywords
- Head and Neck Cancer, Quality of Life, Dietary support
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular dietary supportOther
Systematic and regular dietary support after radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Group of patients with standard of care: the nutritional support is conducted by physicians. No systematic dietary support |
| Regular dietary support | Experimental | Group of patients will benefit from a systematic and regular dietary support. Patients will be followed by a dietitian 1 month and 3 month after radiotherapy in hospital. Then, dietitian will realize a telephon interview 2 and 5 months after radiotherapy Receives: Other: Regular dietary support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's proportion presenting a decrease of 5% of their weight 6 months after the end of radiotherapy
the weight will measured by physician just after radiotherapy and after 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start1 Dec 2016
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, Centre Francois Baclesse
- Responsible party
- Sponsor
- Investigators
- Emmanuel BABIN, Pr, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789267
- Sponsor's protocol ID
- 2015-A01684-45
- Acronym
- NUQUE3
- Status last verified
- Apr 2018
- First submitted
- 17 Mar 2016
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
- ClinicalTrials.gov ID
- NCT02789267
- Acronym / sponsor ID
- NUQUE3 / 2015-A01684-45
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Quality of Life, Dietary support
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, Centre Francois Baclesse
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 2 Jun 2016 (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.
Undernutrition in cancerology is frequent because it's present for thirty to fifty percent of the patients at the time of the diagnosis. According to the recommendations of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five percent loss of weight compared to the previous weight increases the risk of toxicity of the chemotherapy and worsens the patient's quality of life.
The treatment of the tumors of the head and the neck comes along very often with a loss of weight (17.4 % after one year of radiotherapy according to the study of Larsson et al.) which varies with the chosen treatment, and shows a major risk at the patients whose therapeutic sequence involves a radiotherapy. The irradiation of the upper aerodigestive tract is source of aftereffects and late complications: xerostomia, oedemas of mucous membranes.
The xerostomia, connected to the damage of the salivary glands, is a frequent complaint of the patients. It reveals or even increases, a dysphagia. According to Woisard, six months after the end of treatments, forty percent of the patients suffer from a dysphagia.
All these complications limit quantitatively and qualitatively the food intake. The adaptation of the texture of the food is necessary by fifty four percent at three months of the end of treatments according to Logemann et al., and a few patients remain dependent on an long term enteral nutrition.
Beyond a change of the nutritional state, the feeding difficulties or even the absence of resumption of an oral feeding are responsible for a social isolation. The meal which lost its dimension of pleasure becomes a source of fear and obsession for the patient as well as for his relations, and this fact generates family tensions. The quality of life of the patient is heavily affected.
Ravasco showed in his study that the impact on the nutritional state of a nutritional care by dietary advices was more important as the prescription of oral nutritional supplements but based on a short period (the dietary intervention covered only the duration of the radiotherapy). But what would happen after the end of treatments? The investigators emit the hypothesis that a post-therapeutic systematic and regular dietary support has a positive impact on the prevention of the undernutrition among the patients affected by a first cancer of the upper aerodigestive tract whom therapeutic sequence involves a radiotherapy.
Detailed description
The investigators propose a prospective randomized, open and multicentric study. This study has to include 224 patients affected by a head and neck cancer which therapeutic sequence involves a more or less made sensitized radiotherapy. The beginning of the inclusions is planned for May 2016, the end of inclusion 36 months later.
The nutritional state and quality of life will be evaluated 6 months after radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Group of patients with standard of care: the nutritional support is conducted by physicians. No systematic dietary support |
| Regular dietary support | Experimental | Other: Regular dietary supportGroup of patients will benefit from a systematic and regular dietary support. Patients will be followed by a dietitian 1 month and 3 month after radiotherapy in hospital. Then, dietitian will realize a telephon interview 2 and 5 months after radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with first head and neck cancer histologically proved
- treatment by radiotherapy
- no sign of recidive
- life expectancy 3-month-old superior
- OMS score < 3
Key exclusion criteria (4 listed)
- other former cancer
- pregnant woman
- no oral feeding before radiotherapy
- uncontrolled infectious pathology
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 |
|---|---|---|
| Regular dietary supportSystematic and regular dietary support after radiotherapy | Other | Regular dietary support |
Primary outcome
Patient's proportion presenting a decrease of 5% of their weight 6 months after the end of radiotherapy
Time frame: 6 months
the weight will measured by physician just after radiotherapy and after 6 months
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Emmanuel BABIN, Pr principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular dietary support in people with Head and Neck Cancer, run by University Hospital, Caen at 1 site 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 6 inclusion and 4 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 25 Apr 2019. 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 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: Insufficient funding). 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?
Patient's proportion presenting a decrease of 5% of their weight 6 months after the end of radiotherapy (time frame: 6 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 25 Apr 2019.