Clinical trial · Interventional

Adaptated Physical Activity in Cancerology

APACAN study_Adaptated Physical Activity in Cancerology

NCT02252991CI-TRIAL-00020350APACANterminatedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Difficulty to include patients

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
physical activity	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
OTHER
label
Arm A with physical activity during the treatment
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.
interventionNames
1. Other: physical activity
type
OTHER
label
Arm B with physical activity after the treatment
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.
interventionNames
1. Other: physical activity

Primary outcomes (1)

measure
Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.