Adaptated Physical Activity in Cancerology

Breast Cancer Clinical Trial

— APACAN  

Official title:

APACAN study_Adaptated Physical Activity in Cancerology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02252991
• Other study ID #: 2014-A00091-46
• Status: Terminated
• Phase: N/A
• First received: September 11, 2014
• Last updated: December 23, 2015
• Start date: September 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• physical activity
Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.	The scores of fatigue at the end of treatment and at the inclusion will be compared.	up to 6 months	No
Secondary	QLQ-C30	Comparison of the scores of QLQ-C30 assessed at the end of the treatment and at the inclusion.	up to 6 months	No