Clinical trial NCT02252991: Adaptated Physical Activity in Cancerology
Official title: APACAN study_Adaptated Physical Activity in Cancerology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Fatigue
Physical activity
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.
timeFrame: up to 6 months
Secondary outcomes:
measure: QLQ-C30
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre Jean Perrin
name: Yves Jean Bignon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: