Trials / Terminated
TerminatedNCT01910753
Physical Activity Program and Nutrition Therapeutic Education During Treatment of Head and Neck Cancer Population
Feasibility Study: Physical Activity Program Associated Wtih Nutrition Therapeutic Education in Head and Neck Cancer Population Treating by Chemotherapy With or Without Radiotherapy.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- University Hospital, Limoges · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2013-07-30
- Last updated
- 2016-09-07
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01910753. Inclusion in this directory is not an endorsement.