Squamous Cell Carcinoma of the Head and NeckNUQUE2NCT02510859
Nutrition and Life QUality Patients With Head and Neck Cancers
A study testing Systematic nutritional consultation at home in people with Squamous Cell Carcinoma of the Head and Neck, run by University Hospital, Caen at 1 site in France.
Trial summary
Malnutrition is currently a major factor of morbidity and mortality, which poses a major public health problem in developing countries but also, albeit to a lesser degree and for different reasons, for industrialized countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Systematic nutritional consultation at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Jan 2014
- 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 over 18 years
- having Given written consent
- Life span > 3 months
- Score WHO <3
- Patient With cancer of Aero-Digestive tract Superior histologically proven (including salivary glands)
- Stable , presenting no other progressive neoplasia except VADS
- Patient to be treated with radiotherapy alone or concomitant chemoradiotherapy or radiotherapy with cetuximab or postoperative radiotherapy roughly sensitized.
- Patient Fluent French.
Who cannot join
- Patient with history of malignancy, except basal cell cancer or neck cancer treated and cured
- Patient who underwent salvage surgery other than a course node,
- Patient with other evolutionary neoplasia at the time of examination
- Patient having previously had a mutilating surgery (causing effects on swallowing and feeding)
- Uncontrolled infectious disease
- Lactating or pregnant women or lack of contraception in reproductive years
- Intercurrent pathology involving life-threatening
Trial locations and contacts
1 site in 1 country.
About this study
Malnutrition is currently a major factor of morbidity and mortality, which poses a major public health problem in developing countries but also, albeit to a lesser degree and for different reasons, for industrialized countries. It is recognized that in countries "of the North", from 30 to 60% of hospitalized patients suffer from dénutrition.
In any case, it is covered by an imbalance between the contributions and needs; the two main mechanisms are a delivery failure (fasting, ingesting difficulty ...) and / or increased requirements (hypermetabolism ...). In cancer patients the Aero-Digestive Upper Airways (VADS), this imbalance is even more pronounced than the two mechanisms exist and potentiate. Patients included in this study are a population at risk, because of their therapeutic containing at least radiotherapy. It is recognized that this form of therapy exposes dental complications, mucous, saliva. These complications have a deleterious effect on the nutritional status of patients.
Read more
The diagnosis, treatment and prevention of dénutritions have an important place in the therapeutic strategies of this type of cancer because it is events whose incidence and morbid consequences are high and for which there are appropriate nutritional treatments in most cas. While the complete correction of malnutrition generally passes by the effective etiological treatment of the causal pathology, therapeutic efficacy of the latter is often conditioned by the nutritionnel state.
In addition to these concepts, investigators wants to study the benefits of a diet followed during the irradiation phase of patients with head and neck cancers and New treaties. We propose a randomized, phase III, open, multicenter, to evaluate the impact of a dietary consultation at home on the life quality of patients with head and neck cancer including first therapeutic sequence involves radiotherapy more or less aware. The duration of the study is 24 months.
The main objective is to evaluate the impact of a dietary consultation at home on the life quality of patients with head and neck cancer including first therapeutic sequence involves a more or less sensitized radiotherapy.
- Being tested
- Systematic nutritional consultation at home
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic nutritional consultation at homeOther
Patients will be followed by a dietician at the patient's home at weeks 2 (S2) and 4 (S4) of radiotherapy, then at the end of radiotherapy at T0. Monitoring will be continued 15 days after the end of irradiation and then one month (T1 and 2 months (T2). A personalized follow will be performed and a document entitled "Dietary own program" will be given to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Systematic nutritional consultation at home | Experimental | Patients will be followed by a dietician at the patient's home at weeks 2 (S2) and 4 (S4) of radiotherapy, then at the end of radiotherapy at T0. Monitoring will be continued 15 days after the end of irradiation and then one month (T1 and 2 months (T2). A personalized follow will be performed and a document entitled "Dietary own program" will be given to the patient. Receives: Other: Systematic nutritional consultation at home |
| Traditional nutritional follow up | No intervention | Traditional nutritional follow up that is to say with a nutritional consultation before starting treatment and then when necessary on medical advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVA score "Quality of Life = overall mental and social physical condition at the time of the interview"
Measured: after 3 months of the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startDec 2010
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510859
- Sponsor's protocol ID
- 10-101
- Acronym
- NUQUE2
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2015
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Roussel LM, Micault E, Peyronnet D, Blanchard D, Guarnieri S, Choussy O, Gery B, Bequignon A, Joubert C, Parienti JJ, Babin E. Intensive nutritional care for patients treated with radiotherapy in head and neck cancer: a randomized study and meta-analysis. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):977-987. doi: 10.1007/s00405-016-4278-9. Epub 2016 Aug 27.
PubMed 27568350
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Life QUality Patients With Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT02510859
- Acronym / sponsor ID
- NUQUE2 / 10-101
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2014 (actual)
- First posted
- 29 Jul 2015 (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.
Malnutrition is currently a major factor of morbidity and mortality, which poses a major public health problem in developing countries but also, albeit to a lesser degree and for different reasons, for industrialized countries. It is recognized that in countries "of the North", from 30 to 60% of hospitalized patients suffer from dénutrition.
In any case, it is covered by an imbalance between the contributions and needs; the two main mechanisms are a delivery failure (fasting, ingesting difficulty ...) and / or increased requirements (hypermetabolism ...). In cancer patients the Aero-Digestive Upper Airways (VADS), this imbalance is even more pronounced than the two mechanisms exist and potentiate. Patients included in this study are a population at risk, because of their therapeutic containing at least radiotherapy. It is recognized that this form of therapy exposes dental complications, mucous, saliva. These complications have a deleterious effect on the nutritional status of patients.
The diagnosis, treatment and prevention of dénutritions have an important place in the therapeutic strategies of this type of cancer because it is events whose incidence and morbid consequences are high and for which there are appropriate nutritional treatments in most cas. While the complete correction of malnutrition generally passes by the effective etiological treatment of the causal pathology, therapeutic efficacy of the latter is often conditioned by the nutritionnel state.
In addition to these concepts, investigators wants to study the benefits of a diet followed during the irradiation phase of patients with head and neck cancers and New treaties. We propose a randomized, phase III, open, multicenter, to evaluate the impact of a dietary consultation at home on the life quality of patients with head and neck cancer including first therapeutic sequence involves radiotherapy more or less aware. The duration of the study is 24 months.
The main objective is to evaluate the impact of a dietary consultation at home on the life quality of patients with head and neck cancer including first therapeutic sequence involves a more or less sensitized radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systematic nutritional consultation at home | Experimental | Other: Systematic nutritional consultation at homePatients will be followed by a dietician at the patient's home at weeks 2 (S2) and 4 (S4) of radiotherapy, then at the end of radiotherapy at T0. Monitoring will be continued 15 days after the end of irradiation and then one month (T1 and 2 months (T2). A personalized follow will be performed and a document entitled "Dietary own program" will be given to the patient. |
| Traditional nutritional follow up | No intervention | –Traditional nutritional follow up that is to say with a nutritional consultation before starting treatment and then when necessary on medical advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients over 18 years
- having Given written consent
- Life span > 3 months
- Score WHO <3
- Patient With cancer of Aero-Digestive tract Superior histologically proven (including salivary glands)
Key exclusion criteria (7 listed)
- Patient with history of malignancy, except basal cell cancer or neck cancer treated and cured
- Patient who underwent salvage surgery other than a course node,
- Patient with other evolutionary neoplasia at the time of examination
- Patient having previously had a mutilating surgery (causing effects on swallowing and feeding)
- Uncontrolled infectious disease
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 |
|---|---|---|
| Systematic nutritional consultation at homePatients will be followed by a dietician at the patient's home at weeks 2 (S2) and 4 (S4) of radiotherapy, then at the end of radiotherapy at T0. Monitoring will be continued 15 days after the end of irradiation and then one month (T1 and 2 months (T2). A personalized follow will be performed and a document entitled "Dietary own program" will be given to the patient. | Other | Systematic nutritional consultation at home |
Primary outcome
EVA score "Quality of Life = overall mental and social physical condition at the time of the interview"
Time frame: after 3 months of the end of treatment
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 2 Apr 2026.
- Results publication: PubMed 27568350Roussel LM, Micault E, Peyronnet D, Blanchard D, Guarnieri S, Choussy O, Gery B, Bequignon A, Joubert C, Parienti JJ, Babin E. Intensive nutritional care for patients treated with radiotherapy in head and neck cancer: a randomized study and meta-analysis. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):977-987. doi: 10.1007/s00405-016-4278-9. Epub 2016 Aug 27.
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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 Systematic nutritional consultation at home in people with Squamous Cell Carcinoma of the Head and Neck, 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 2 Apr 2026. 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 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?
EVA score "Quality of Life = overall mental and social physical condition at the time of the interview" (time frame: after 3 months of the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510859, which also lists 1 linked publication.
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 2 Apr 2026.