Exercise Therapy During Radiotherapy

NCT ID: NCT04507789

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2021-04-10

Brief Summary

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The main purpose of our study is to investigate the effects of exercise therapy on upper extremity functions in patients receiving radiotherapy to the axillary region after breast cancer surgery.

Detailed Description

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Our study will take in place in radiation oncology clinic. In routine the patients which will receive axillary area radiotherapy will randomized into 2 groups will explained in study arms section later. There are papers explained about radiotherapy side effects to upper extremity functions. But there is lack of evidence about exercise therapy during radiotherapy protocol to cope with its side effects to upper extremity functions. In this study we will compare two groups upper extremity function related outcomes at the end of the radiotherapy sessions and also before and after results for two groups.

Conditions

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Breast Cancer Exercise Therapy Radiotherapy Upper Extremity Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exercise intervention group

This group will be taken an exercise intervention during their radiotherapy programme.

Group Type EXPERIMENTAL

exercise intervention

Intervention Type OTHER

Exercise protocol will consist of the recommended special exercise sets for upper extremity problems on mastectomy patients. The upper extremity protocol has published in 2018 by Richmond and friends called prevention of musculoskeletal shoulder problems after breast cancer treatment UK-PROSPER protocol.this special protocol has unique exercise sets for to restore shoulder range of motion, to maintain good force level of upper extremity muscles and stretch exercises especially to the muscles around the radiotherapy area. Exercises will be done under the supervision of a specialized physiotherapist about upper extremity disorders.

routine radiotherapy protocol

This group will not be taken into an exercise intervention during their radiotherapy programme.

Group Type ACTIVE_COMPARATOR

routine radiotherapy protokol

Intervention Type OTHER

This intervention is only an observation to patients during their routine radiotherapy protocol. There will be no exercise intervention for the upper extremity for the patient in this group.

Interventions

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exercise intervention

Exercise protocol will consist of the recommended special exercise sets for upper extremity problems on mastectomy patients. The upper extremity protocol has published in 2018 by Richmond and friends called prevention of musculoskeletal shoulder problems after breast cancer treatment UK-PROSPER protocol.this special protocol has unique exercise sets for to restore shoulder range of motion, to maintain good force level of upper extremity muscles and stretch exercises especially to the muscles around the radiotherapy area. Exercises will be done under the supervision of a specialized physiotherapist about upper extremity disorders.

Intervention Type OTHER

routine radiotherapy protokol

This intervention is only an observation to patients during their routine radiotherapy protocol. There will be no exercise intervention for the upper extremity for the patient in this group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients İn the age range of 18-65
* Receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis

Exclusion Criteria

* Radiotherapy area to contain only the chest wall
* Any orthopedic injury or trauma involving the upper extremity prior to or during the cancer diagnosis
* The presence of metastases in any area other than breast tissue
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Damlagül AYDIN ÖZCAN

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YAVUZ YAKUT

Role: STUDY_CHAIR

Professor

Güçlü Sezai Kılıçoğlu

Role: STUDY_CHAIR

assistant doctor

Locations

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Dr. Abdurrahman Yurtaslan Onkoloji Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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DAMLAGÜL AYDİN ÖZCAN

Role: CONTACT

+90 0312 3052525

Güçlü Sezai Kılıçoğlu

Role: CONTACT

+90 0312 3360909

Facility Contacts

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Damlagül Aydin Özcan

Role: primary

0530 873 99 63

Other Identifiers

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2020-01

Identifier Type: -

Identifier Source: org_study_id

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