Physical Activity Program and Nutrition Therapeutic Education During Treatment of Head and Neck Cancer Population

Neck Cancer Clinical Trial

— APANVADS  

Official title:

Feasibility Study: Physical Activity Program Associated Wtih Nutrition Therapeutic Education in Head and Neck Cancer Population Treating by Chemotherapy With or Without Radiotherapy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01910753
• Other study ID #: I12018 APANVADS
• Status: Terminated
• Phase: N/A
• First received: July 22, 2013
• Last updated: September 6, 2016
• Start date: May 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the feasibility of resistance training and physical functioning associated with nutrition therapeutic education in head and neck cancer patients, during their treatment (chemotherapy with or without radiotherapy).

Description:

The loss of muscle mass (i.e., sarcopenia) has been identified as a negative prognosis descriptor, disregarding the type of cancer. It is also a predictive descriptor for treatment-related toxicity. Therefore it appears crucial to save muscle mass of patients, following an adequate physical training together with a personalised diet program. The latter point is of major importance as malnutrition concerns 45% patients having head and neck cancer cancer, who stop physical activity due to extreme tiredness and decrease of quality of life. In the present project, we plan a physical activity program that would be adapted to each patient, accompanied by the rethought diet over a 3-month period. The adapted physical activity (APA) is constituted of two aerobic stages and one resistance training stage per a week. The evaluation will then proceed at three different moments, namely (i) at T0 i.e., beginning of the program, (ii) at 3 months i.e., when the program will be stopped, and (iii) at 6 months i.e., three months after the program stop. This evaluation will include the success rate, the level of satisfaction, the physiological parameters (VO2max, muscle mass and strength, BMI) and quality of life.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18 years

• Written informed consent provided before any study specific procedures

• Consent to cooperate for clinical assessments

• Affiliation to a social security regime or beneficiary of equivalent social protection

• Performance status between 0 and 2

• Squamous cell carcinoma of oral cavity, oropharynx or hypopharynx

• Stage III - IV (T1-T4, N0-N3, M)(UICC 2002)

• Indication of radiotherapy and chemotherapy post-operative or first-line metastatic chemotherapy or in inoperable condition

• Ability to understand the nature, goal and study methodology

Exclusion Criteria:

• Prior neoadjuvant chemotherapy

• timed vital capacity< 70%

• Presence of another severe pathology including:

• severe or chronic cardiac, pulmonary, renal and/or hepatic insufficiencies

• Cons-indication to physical activity practice, at discretion of the investigator

• Patient under guardianship

• Psychological, social, geographical, or familial reasons prohibiting physical activity and follow-up

• Any other primary tumor during the last 5 years

• Pregnant or nursing

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Neck Cancer

Intervention

Procedure:
• APA
A 3-month program for physical activity and diet education will be followed. An exercise specialist will supervise patients twice per week, during the first six weeks. They will also follow nutrition counselling and therapeutic education by a dietician once per week. During the last six weeks, they will just follow a guide for safe and appropriate exercise regimen. The dietician will call patient weekly during this final period.

Locations

Country	Name	City	State
France	CHU LIMOGES - Explorations Fonctionnelles Respiratoires	Limoges
France	CHU LIMOGES - Oncologie	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of the APA with a composite outcome measure	The evaluation criteria for the PA program will be: The success rate that will be reached if 80% of physical exercises will be performed by the patient, over the 3-month period,; The level of satisfaction that will be evaluated with questionnaires filled by the patient.	3 months	No
Secondary	Evaluation of the personalised diet program and the therapeutic education with a composite outcome measure.	The evaluation criteria for the personalised diet program and the therapeutic education will be: The success rate that will be reached if 80% of requirements will be addressed by the patient,; The level of satisfaction that will be evaluated with questionnaires filled by the patient.	3 months	No