NCT02789267: NUQUE3

Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy

Terminated NA Last updated 25 April 2019

What this trial tests

NA trial testing Regular dietary support in Head and Neck Cancer in 7 participants. Terminated before completion.

Timeline

1 December 2016

Primary endpoint
1 March 2018

1 March 2018

Quick facts

Lead sponsor	University Hospital, Caen
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	7
Start date	1 December 2016
Primary completion	1 March 2018
Estimated completion	1 March 2018
Sites	1 location across France

Drugs / interventions tested

• Regular dietary support

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

University Hospital, Caen

Who can join

18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.