Physical Activity Program and Nutrition Therapeutic Education During Treatment of Head and Neck Cancer Population
Conditions
Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head and neck cancer,, physical activity,, nutrition therapeutic education
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: APA
Type: Procedure
Overall Status
Recruiting
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).
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
CHU LIMOGES - Explorations Fonctionnelles Respiratoires
Limoges, France
Status: Recruiting
Contact: Francois VINCENT, MD - 05 55 05 61 45
CHU LIMOGES - Oncologie
Limoges, France
Status: Recruiting
Contact: Sabrina FALKOWSKI, MD - 05 55 05 61 00
Start Date
May 2013
Completion Date
December 2014
Sponsors
University Hospital, Limoges
Source
University Hospital, Limoges
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page