Adaptated Physical Activity in Cancerology

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Other: physical activity

• 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

Arm && Interventions

Group	Intervention	Description
Arm B with physical activity after the treatment	physical activity	In the arm B, the physical activity will be realised after treatment. Blood samples will be realised. Questionnaries will be given to the patients.
Arm A with physical activity during the treatment	physical activity	In the arm A, patients will realise physical activity during the treatment. Blood samples will be realised. Questionnaries will be given to the patients.

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.