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Nutrition and Life QUality Patients With Head and Neck Cancers (NUQUE2)

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Systematic nutritional consultation at home
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Service ORL et de chirurgie cervico- faciale

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Systematic nutritional consultation at home

Traditional nutritional follow up

Arm Description

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.

Traditional nutritional follow up that is to say with a nutritional consultation before starting treatment and then when necessary on medical advice

Outcomes

Primary Outcome Measures

EVA score "Quality of Life = overall mental and social physical condition at the time of the interview"

Secondary Outcome Measures

Full Information

First Posted
July 27, 2015
Last Updated
July 27, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02510859
Brief Title
Nutrition and Life QUality Patients With Head and Neck Cancers
Acronym
NUQUE2
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systematic nutritional consultation at home
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional nutritional follow up
Arm Type
No Intervention
Arm Description
Traditional nutritional follow up that is to say with a nutritional consultation before starting treatment and then when necessary on medical advice
Intervention Type
Other
Intervention Name(s)
Systematic nutritional consultation at home
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Service ORL et de chirurgie cervico- faciale
City
Caen CHU
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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Nutrition and Life QUality Patients With Head and Neck Cancers

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