Adaptated Physical Activity in Cancerology (APACAN)

December 23, 2015 updated by: Centre Jean Perrin

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: up to 6 months
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
Time Frame: up to 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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