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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
|
Patients will realise physical activity either during their treatment, either after their treatment.
They will have practise a physical activity three times per week.
|
|
他の：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.
|
Patients will realise physical activity either during their treatment, either after their treatment.
They will have practise a physical activity three times per week.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.
時間枠：up to 6 months
|
The scores of fatigue at the end of treatment and at the inclusion will be compared.
|
up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
QLQ-C30
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Yves Jean Bignon, MD,PhD、Centre Jean Perrin
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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