Adaptated Physical Activity in Cancerology (APACAN)

Centre Jean Perrin

Status: Terminated

Conditions: Breast Cancer

Treatments: Other: physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02252991

2014-A00091-46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

3 participants in 2 patient groups

Arm A with physical activity during the treatment

Other group

Description:

In the arm A, patients will realise physical activity during the treatment. Blood samples will be realised. Questionnaries will be given to the patients.

Treatment:

Other: physical activity

Arm B with physical activity after the treatment

Other group

Description:

In the arm B, the physical activity will be realised after treatment. Blood samples will be realised. Questionnaries will be given to the patients.

Treatment:

Other: physical activity