Adaptated Physical Activity in Cancerology (APACAN)

APACAN study_Adaptated Physical Activity in Cancerology

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: physical activity

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm A with physical activity during the treatment; In the arm A, patients will realise physical activity during the treatment. Blood samples will be realised. Questionnaries will be given to the patients.	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.
Other: Arm B with physical activity after the treatment; In the arm B, the physical activity will be realised after treatment. Blood samples will be realised. Questionnaries will be given to the patients.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QLQ-C30	Comparison of the scores of QLQ-C30 assessed at the end of the treatment and at the inclusion.	up to 6 months

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Yves Jean Bignon, MD,PhD, Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Fatigue; Breast cancer; Physical activity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2014-A00091-46

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No