Clinical trial NCT01910753: Physical Activity Program and Nutrition Therapeutic Education During Treatment of Head and Neck Cancer Population
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neck Cancer
Keywords: Head and neck cancer,
physical activity,
nutrition therapeutic education
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: feasibility of the APA with a composite outcome measure
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of the personalised diet program and the therapeutic education with a composite outcome measure.
timeFrame: 3 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU LIMOGES - Explorations Fonctionnelles Respiratoires
city: Limoges
country: France
facility: CHU LIMOGES - Oncologie
Study officials:
affiliation: Limoges UH
name: FRANCOIS Vincent, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU LIMOGES - Oncologie
name: Sabrina FALKOWSKI, MD
role: PRINCIPAL_INVESTIGATOR
References: