NCT05970250

Brief Summary

Chemotherapy can damage bone marrow and therefore impair the production of white blood cells, platelets and red blood cells with the resulting anemia and osteoporosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 24, 2023

Last Update Submit

July 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessing the change in bone mineral density

    By using DEXA (dual-energy X-ray absorptiometry): Dual-energy X-ray absorptiometry (DEXA) is a clinically proven method of measuring bone mineral density (BMD) in the lumbar spine, proximal femur, forearm, and whole body. It is used primarily in the diagnosis and management of osteoporosis and other disease states characterized by abnormal BMD, as well as to monitor response to therapy for these conditions .

    at baseline and after 2 months of intervention

Study Arms (3)

Whole body vibration group

EXPERIMENTAL

In this group (the first study group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received the whole body vibration, 20 minutes 3 times per week for 2 months and drug therapy (vitamin D supplements and calcium).

Other: Whole body vibration groupDrug: vitamin D supplements and calcium

Weight bearing exercises group

EXPERIMENTAL

In this group (the second study group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received aerobic exercise on treadmill as form of weight bearing exercise 20 minutes 3 times per week for 2 months and drug therapy (vitamin D supplements and calcium).

Other: Weight bearing exercisesDrug: vitamin D supplements and calcium

drug therapy group

OTHER

In this group (control group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received only drug therapy (vitamin D supplements and calcium. Measurements were conducted before starting the treatment as a first record, at end of the second month of treatment as second record and make follow up after 3 months as final record.

Drug: vitamin D supplements and calcium

Interventions

Whole body vibration apparatus (model Power plate -my5tm, made in United States) with frequency 30 - 40 Hz was used for the whole body vibration program by reciprocating vertical displacements on the left and right side of a fulcrum.

Whole body vibration group

Electronic treadmill Kettler- marathon model No 7899-800, made in Germany (as form of weight bearing exercises), which was adjusted to the subject's comfortable walking speed. Generally, during the treadmill training, its speed and inclination are electronically adjusted, and it is also provided with a control panel to display the exercise parameters. It allows for the comfortable running without joint or back pains through a perfect combination between aluminium-pertinax running deck, shock absorbers and overall shock-damping design.

Weight bearing exercises group

vitamin D supplements and calcium

Weight bearing exercises groupWhole body vibration groupdrug therapy group

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis.
  • Their age ranges from 35-55 years old.
  • All patients will have the same medical and nursing care.
  • All the patients will receive a good explanation of treatment and measurement device.
  • They are neurologically free.

You may not qualify if:

  • Patients will be excluded from this study for any of the following causes:
  • Uncooperative patients.
  • Instability of patient's medical condition.
  • Association of another medical problem.
  • Patients who have diabetes.
  • Patients who have history of medical chronic relevant diseases.
  • Patients who have acute or chronic hepatitis.
  • Patients who have pacemaker.
  • Patients who have genitourinary infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic faculty of physical therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Conditions

OsteoporosisBreast Neoplasms

Interventions

Calcium

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Eman Elgendy

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 1, 2023

Study Start

January 20, 2022

Primary Completion

April 20, 2022

Study Completion

July 20, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations