NCT06764394

Brief Summary

Chemotherapy, hormone therapy and radiotherapy used in the treatment of breast cancer try to prevent the recurrence of cancer. In addition to the benefits of radiotherapy, such as a decrease in recurrence and an increase in long-term survival, it may have side effects that may affect the well-being and daily life activities of patients. One of the treatment modalities used to cope with treatment-related side effects is myofascial release exercises. Myofascial release exercises can help reduce adhesions caused by scar tissue and fibrosis caused by radiation. In the literature, there is no study investigating the effect of myofascial release exercises on pectoralis major muscle viscoelastic structure. For this purpose, our study aims to investigate the effect of myofascial release exercises performed in addition to home exercise programme on pectoralis major muscle viscoelastic structure, pain, range of motion and shoulder functionality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

December 20, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

November 25, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 2, 2025

Last Update Submit

November 22, 2025

Conditions

Keywords

myofascial release exercises, breast cancer, radiotherapy

Outcome Measures

Primary Outcomes (2)

  • Tone - pectoralis major

    Myoton® PRO (Myoton Ltd, Myoton AS, Estonia) device will be used to objectively evaluate the measurement of Pectoralis Major muscle tone of the patients who will participate in the study. Myoton® PRO is a portable digital device that measures the tone with an objective and noninvasive method. A constant pre-pressure (0.18 N) is applied to the skin surface to compress the subcutaneous superficial tissues. The tension state of the tissue that characterized by the natural oscillation frequency; Hz.

    6 weeks

  • Range of motion

    Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.

    6 weeks

Secondary Outcomes (3)

  • Pain - Visual Analogue Scale

    6 weeks

  • Shoulder Pain and Disability Index- SPADI

    6 weeks

  • Quality of Life- Functional Assessment of Cancer Therapy-Breast" (FACT-B)

    6 weeks

Study Arms (2)

home based exercise group

ACTIVE COMPARATOR

home-based exercise 5 days a week

Myofascial release exercise group

EXPERIMENTAL

home based exercise plus Myofascial release exercise

Other: Exercise

Interventions

home based exercise 5 days/week

Also known as: home based exercise

Eligibility Criteria

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

You may qualify if:

  • Stage I-II-III defined by radiation oncologists after breast cancer surgery and who will start radiotherapy
  • Breast conserving surgery or total mastectomy with axillary lymph node dissection during surgery
  • No neurological or orthopaedic problems that may limit the range of motion of the shoulder joint in the preoperative evaluations,
  • Individuals who volunteer to participate in the study will be included.

You may not qualify if:

  • Previous breast clamp surgery on the same side or contralateral side,
  • With a metastatic cancer focus,
  • Post-surgical resistance, infection and open wound, pacemaker,
  • Patients with a Mini Mental State Examination test score of less than 21 will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU. Prof. Dr. Cemil Taşçıoğlu City Hospital- Oncology Clinic

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant professor

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

December 20, 2024

Primary Completion

March 30, 2025

Study Completion

May 10, 2025

Last Updated

November 25, 2025

Record last verified: 2025-01

Locations