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

University of Limoges (UL)

Status

Terminated

Conditions

Neck Cancer

Treatments

Procedure: APA

Study type

Interventional

Funder types

Other

Identifiers

NCT01910753

I12018 APANVADS

Details and patient eligibility

About

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).

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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