An interventional study of Regular dietary support in Head and Neck Cancer, sponsored by University Hospital, Caen. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-25.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Supportive care
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 7 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group of patients with standard of care: the nutritional support is conducted by physicians. No systematic dietary support
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
Other: Regular dietary support
Systematic and regular dietary support after radiotherapy
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
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Caen