NCT03658265

Brief Summary

Patients who underwent modified radical mastectomy were enrolled in the study. 200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 Isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive resistance training group. The effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed. The results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

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

First Submitted

Initial submission to the registry

August 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

August 29, 2018

Last Update Submit

October 6, 2020

Conditions

Shoulder DysfunctionBreast CancerModified Radical Mastectomy

Keywords

breast cancer modified radical mastectomyshoulder dysfunctionRehabilitation Training

Outcome Measures

Primary Outcomes (6)

  • Constant-Murley Shoulder Score

    The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.

    1 weeks after surgery

  • Constant-Murley Shoulder Score

    The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.

    3 weeks after surgery

  • Constant-Murley Shoulder Score

    The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.

    6 weeks after surgery

  • Constant-Murley Shoulder Score

    The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.

    9 weeks after surgery

  • Constant-Murley Shoulder Score

    The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.

    12 weeks after surgery

  • Constant-Murley Shoulder Score

    The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100. Higher scores indicate better shoulder function.

    18 weeks after surgery

Secondary Outcomes (5)

  • Active and passive range of motion

    3 days，1, 2, 3, 6, and 9 weeks after surgery

  • Shoulder joint muscle strength

    3 days, 3, 6, 9 weeks after surgery

  • The power of gripping

    1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery

  • EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire

    1, 3, 9, 12, 18 weeks after surgery

  • SF-36 Health status questionnaire

    1, 3, 9, 12, 18 weeks after surgery

Other Outcomes (4)

  • Visual Analogue Scale （VAS)

    1 day, 3 days, 1 week, 2 weeks after surgery

  • Sum drainage from chest wall and axillary after operation.

    1 day, 3 days, 1 week, 2 weeks after surgery

  • Upper limb circumference

    Preoperative 3, 9, 12,18 weeks after surgery

  • +1 more other outcomes

Study Arms (4)

7 days SIE plus 4 weeks PRE

ACTIVE COMPARATOR

Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 4 weeks after surgery.

Other: 7 days SIE plus 4 weeks PRE

7 days SIE plus 3 weeks PRE

EXPERIMENTAL

Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery.

Other: 7 days SIE plus 3 weeks PRE

3 days SIE plus 4 weeks PRE

EXPERIMENTAL

Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery.

Other: 3 days SIE plus 4 weeks PRE

3 days SIE plus 3 weeks PRE

EXPERIMENTAL

Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery.

Other: 3 days SIE plus 3 weeks PRE

Interventions

7 days SIE plus 4 weeks PREOTHER

Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.

7 days SIE plus 4 weeks PRE
7 days SIE plus 3 weeks PREOTHER

Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.

7 days SIE plus 3 weeks PRE
3 days SIE plus 4 weeks PREOTHER

Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.

3 days SIE plus 4 weeks PRE
3 days SIE plus 3 weeks PREOTHER

Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.

3 days SIE plus 3 weeks PRE

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 25 and 75 years;
  • Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy;
  • Postoperative chemotherapy or radiation therapy according to the condition;
  • No other malignant tumors within 5 years;
  • No physical therapy related contraindications;
  • Signing informed consent.

You may not qualify if:

  • The result of SLNB is negative who did not receive ALND;
  • Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
  • Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
  • Combined severe heart disease, cerebrovascular disease, and mental illness;
  • Patients with shoulder joint dysfunction before surgery;
  • Unable to understand the rehabilitation training program provided by doctors or physiotherapists.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan hospital of Wuhan University

Wuhan, Hubei, 430070, China

Location

Related Publications (2)

  • Shu Q, Yang Y, Shao Y, Teng H, Liao R, Li Z, Wu G, Hou J, Tian J. Comparison of Rehabilitation Training at Different Timepoints to Restore Shoulder Function in Patients With Breast Cancer After Lymph Node Dissection: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):728-737. doi: 10.1016/j.apmr.2023.01.021. Epub 2023 Feb 20.

    PMID: 36813015DERIVED

  • Shao YW, Shu Q, Xu D, Teng H, Wu GS, Hou JX, Tian J. Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):16. doi: 10.1186/s13063-020-04954-3.

    PMID: 33407753DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lead

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

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
Principal Investigator

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 5, 2018

Study Start

September 10, 2018

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

The study protocol, statistical analysis plan, informed consent form and clinical study report will be shared online about six months after the trial complete.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
About six months after the trial complete

Locations

CN(1)