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

NCT02789267 | Terminated

• 1 other identifier: 2015-A01684-45
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Quality of Life; Dietary support

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (2)

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

Other: Regular dietary support

Interventions

Regular dietary support OTHER

Systematic and regular dietary support after radiotherapy

Regular dietary support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• other former cancer
• pregnant woman
• no oral feeding before radiotherapy
• uncontrolled infectious pathology

Sponsors & Collaborators

• University Hospital, Caen: lead
• University Hospital, Rouen: collaborator
• Centre Francois Baclesse: collaborator

Study Sites (1)

Caen University Hospital

Caen, 14000, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Emmanuel BABIN, Pr

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: June 2, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 25, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)