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

NCT01910753 | Terminated

• 1 other identifier: I12018 APANVADS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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).

Conditions

Neck Cancer

Keywords

Head and neck cancer,; physical activity,; nutrition therapeutic education

Outcome Measures

Primary Outcomes (1)

• feasibility of the APA with a composite outcome measure

  The evaluation criteria for the PA program will be: * The success rate that will be reached if 80% of physical exercises will be performed by the patient, over the 3-month period, * The level of satisfaction that will be evaluated with questionnaires filled by the patient.

  3 months

Secondary Outcomes (1)

• Evaluation of the personalised diet program and the therapeutic education with a composite outcome measure.

  3 months

Study Arms (1)

APA

EXPERIMENTAL

Patient with neck cancer and accepting the physical activity program .

Procedure: APA

Interventions

APA 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.

APA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (2)

CHU LIMOGES - Explorations Fonctionnelles Respiratoires

Limoges, Limoges, 87042, France

Location

CHU LIMOGES - Oncologie

Limoges, 870, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Behavior

Study Officials

• FRANCOIS Vincent, MD

  Limoges UH

  PRINCIPAL INVESTIGATOR

• Sabrina FALKOWSKI, MD

  CHU LIMOGES - Oncologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 30, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

FR (2)