Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

NCT01331772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-10-30

No results posted yet for this study

Summary

Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA) could improve fitness, quality of life, body image, treatment compliance and reduce fatigue.

After diagnosis of breast cancer, there is many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program.

Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

Conditions

Interventions

OTHER

Control arm

Dietetic follow-up only

OTHER

Intervention arm

Dietetic follow up + adapted physical activity

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV
  • Ligue du Rhône

    collaborator UNKNOWN
  • Fondation de France

    collaborator OTHER
  • Cancéropôle Lyon Auvergne Rhône-Alpes

    collaborator OTHER
  • Lions Club Bourg-en-Bresse et Pérouges

    collaborator UNKNOWN
  • Association Lyonnaise de Logistique Posthospitalière

    collaborator OTHER
  • Ministère de la Recherche

    collaborator UNKNOWN
  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Patrick BACHMANN, MD · Centre Leon Berard

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01331772 on ClinicalTrials.gov