NCT02252991

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable breast-cancer

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 28, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

September 11, 2014

Last Update Submit

December 23, 2015

Conditions

Breast Cancer

Keywords

Breast cancerFatiguePhysical activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • QLQ-C30

    up to 6 months

Study Arms (2)

Arm A with physical activity during the treatment

OTHER

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

Arm B with physical activity after the treatment

OTHER

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

Interventions

physical activityOTHER

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

Arm A with physical activity during the treatmentArm B with physical activity after the treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsFatigueMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yves Jean Bignon, MD,PhD

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 30, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 28, 2015

Record last verified: 2015-12