Adaptated Physical Activity in Cancerology

Not Applicable

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT02252991
• Lead Sponsor: Centre Jean Perrin

Brief Summary

This trial will measure the fatigue in breast cancer patients.

Two groups of patients will be realised:

* Arm A: Physical activity during treatment

* Arm B: No physical activity during treatment but after

The aim of the study is to decrease fatigue, with adequate physical activity, in primary breast cancer patients who receive a treatment for their pathology.

Detailed Description

This is an open monocentric study, randomized in two parallel arms with a waiting list.

The duration of the physical activty will vary according to the duration of the treatment: from 2 to 6 months.

Several questionnaries (fatigue, quality of life, ...) will be given to patients at the inclusion, at the end of the period of treatment and 3 to 6 months after the end of treatment.

One hundred patients are necessary in this study (fifty in each arm). We expect to a stability of the fatigue in Arm A compared to an increase of the fatigue in arm B.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-30
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• Women aged 18 to 75 years (included)
• Patient with a breast tumor, regardless of the stage and size (except metastatic patients)
• Patient with a local recurrence of breast cancer
• Patient with a second non-metastatic breast cancer
• Breast cancer treated, regardless of the surgery, at least by radiotherapy, chemotherapy (neoadjuvant or adjuvant) +/- targeted therapy
• A mandatory social security affiliation.
• Obtaining informed consent in writing, signed and dated.
• Medical certificate of fitness to practice physical (issued by the medical oncologist)

Exclusion Criteria

• Cancer other than breast cancer and / or associated with breast cancer
• Metastatic Cancer
• in case of surgery before treatment, delay before beginning treatment inferior to 1 month post-surgery
• Men
• Woman pregnant
• Patient with cognitive or psychiatric disorders
• Patients suffering from disability
• Significant alterations in nutritional status (malnutrition with BMI <19, obese with BMI> 40, BMI)
• Cardiac contraindication to physical activity
• Knowledge and understanding of the French language enough not to learn the correct way of self-administered questionnaires or respond to questioning
• Participation in another clinical study with a similar objective
• Inability to reach the centers where physical activity takes place

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.	up to 6 months	The scores of fatigue at the end of treatment and at the inclusion will be compared.

Secondary Outcome Measures

Name	Time	Method
QLQ-C30	up to 6 months	Comparison of the scores of QLQ-C30 assessed at the end of the treatment and at the inclusion.