NCT02890316

Brief Summary

To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive and emotional functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

July 19, 2016

Last Update Submit

April 7, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Physiological monitoring of changes in anxiety during radiotherapy with and without homeopathy treatment.

    Attention performance will be assessed by the Pre-Pulse Inhibition (PPI) task by evaluating the startle response test an Galvanic Skin Response differences.

    Days 1, 16, 33 of radiation therapy

Secondary Outcomes (1)

  • Physiological monitoring of changes in attention during radiotherapy with and without homeopathy treatment.

    Days 1, 16, 33 of radiation therapy

Study Arms (2)

Radiation therapy with Homeopathy

EXPERIMENTAL

Patients in this arm will receive the homeopathy remedy during the adjuvant radiation therapy period, from treatment number 16 until the last assessment, 3 times every day.

Other: Homeopathy remedyRadiation: Radiation as adjuvant therapy for breast cancer

Radiation therapy with placebo

PLACEBO COMPARATOR

Patients in this arm will receive the placebo remedy during the adjuvant radiation period, from treatment number 16 until the last assessment, 3 times every day.

Radiation: Radiation as adjuvant therapy for breast cancer

Interventions

Homeopathy remedyOTHER

Homeopathy remedy, prescribed by a physician and prepared by licensed pharmacy.

Radiation therapy with Homeopathy
Radiation as adjuvant therapy for breast cancerRADIATION

Daily radiation therapy.

Radiation therapy with HomeopathyRadiation therapy with placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged at least 18 years with unilateral breast cancer following chemotherapy.
  • Planned to receive 50 Gy whole breast irradiation and lymphatic basin + boost to tumor bed.
  • Capable of giving written informed consent following the instructions of receiving the study remedy or placebo.
  • No co-morbidities known to affect radiotherapy reactions.
  • No co-existing neurological or active psychiatric chronic diseases.
  • No evidence of infection or inflammation of breast to be treated.
  • Not receiving chemotherapy during radiotherapy course. Biological or hormonal therapy will be allowed during the study.

You may not qualify if:

  • Uncontrolled hypertension.
  • Participating in another clinical study with active treatment
  • Substance abuse.
  • Intellectual disabilities.
  • Unable to sign informed concent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merav Ben David

Ramat Gan, Israel

Location

Related Publications (1)

  • Dolev T, Ben-David M, Shahadi I, Freed Y, Zubedat S, Aga-Mizrachi S, Brand Z, Galper S, Jacobson G, Avital A. Attention Dysregulation in Breast Cancer Patients Following a Complementary Alternative Treatment Routine: A Double-Blind Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019470. doi: 10.1177/15347354211019470.

    PMID: 34027702DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Merav Ben-David, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Breast Radiation Unit

Study Record Dates

First Submitted

July 19, 2016

First Posted

September 7, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)