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

NCT ID: NCT01910753

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-06-30

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.

Conditions

Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

APA

Patient with neck cancer and accepting the physical activity program .

Group Type: EXPERIMENTAL

APA

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

FRANCOIS Vincent, MD

Role: PRINCIPAL_INVESTIGATOR

Limoges UH

Sabrina FALKOWSKI, MD

Role: PRINCIPAL_INVESTIGATOR

CHU LIMOGES - Oncologie

Locations

CHU LIMOGES - Explorations Fonctionnelles Respiratoires

Limoges, Limoges, France

CHU LIMOGES - Oncologie

Limoges, , France

Countries

France

Other Identifiers

I12018 APANVADS

Identifier Type: -

Identifier Source: org_study_id