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Trial record 1 of 8 for:    homeopathy | Breast Cancer
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Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment

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ClinicalTrials.gov Identifier: NCT02890316
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Dr. Merav Ben-David, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE September 7, 2016
Last Update Posted Date April 9, 2019
Study Start Date  ICMJE July 2016
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
Physiological monitoring of changes in anxiety during radiotherapy with and without homeopathy treatment. [ Time Frame: Days 1, 16, 33 of radiation therapy ]
Attention performance will be assessed by the Pre-Pulse Inhibition (PPI) task by evaluating the startle response test an Galvanic Skin Response differences.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
Physiological monitoring of changes in attention during radiotherapy with and without homeopathy treatment. [ Time Frame: Days 1, 16, 33 of radiation therapy ]
An interview assessing the changes attention with the Fatigue Symptom Inventory scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
Official Title  ICMJE Cognitive and Emotional Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
Brief Summary To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive and emotional functions.
Detailed Description

Sixty four female patients who underwent Chemotherapy and are planned to receive adjuvant whole breast radiation in the radiation departmental at the Sheba Medical Center, and who give a written consent for participation, will be included in the study.

Patients will undergo routine CT simulation and will receive 50 Gy in daily fractions of 2 Gy, five times a week (for total of 33 sessions during ~7 weeks, including boost of 8 fractions to the tumor bed) to the whole breast and lymphatic basins, according to the standard departmental protocol. Demographic and cancer treatment information will be collected, as well as Body mass index (BMI). At the first RT session (first assessment) and following 16-20 sessions of radiotherapy (second assessment), all patients will be evaluated for:

(i) fatigue level utilizing the Fatigue Symptom Inventory (FSI). (ii) attention performance utilizing the Pre-Pulse Inhibition (PPI) task. (iii) anxiety level utilizing both the startle response test and examining the Galvanic Skin Response (GSR) differences.

All examination will be conducted after the daily radiotherapy session. The homeopathic doctor will conduct an individual homeopathic evaluation during the second assessment meeting to all participants. According to these assessments, the pharmacist will prepare and provide 64 blinded numbered sets, 40 of which will contain the study remedy and 24 will contain the carrier only (i.e placebo).

Upon entry to the study after meeting the exclusion/inclusion criteria, a number from 1-64 will be drawn and the patient will receive the corresponding treatment.

The preparation of the homeopathic treatment (sugar globule containing the homeopathic dilution) is held in a licensed pharmacy and according to the Israeli Ministry of Health instructions of preparation. Sixty globules of sugar are wetted in the final diluted solution and dried for several minutes, and will be packed in the pharmacy to be consumed by the patients 3 times a day, 15 minutes before meal.

Placebo treatment is 1% sugar globule, similar in form and hedonic value of the aforementioned homeopathic globule.

During the 32-33 sessions of radiotherapy (third assessment), all patients will be re-assessed for the third time as before (i.e. first and second assessments). A fourth assessment to be held one month after the completion of radiotherapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Other: Homeopathy remedy
    Homeopathy remedy, prescribed by a physician and prepared by licensed pharmacy.
  • Radiation: Radiation as adjuvant therapy for breast cancer
    Daily radiation therapy.
Study Arms  ICMJE
  • Experimental: Radiation therapy with Homeopathy
    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.
    Interventions:
    • Other: Homeopathy remedy
    • Radiation: Radiation as adjuvant therapy for breast cancer
  • Placebo Comparator: Radiation therapy with placebo
    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.
    Intervention: Radiation: Radiation as adjuvant therapy for breast cancer
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2016)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Uncontrolled hypertension.
  2. Participating in another clinical study with active treatment
  3. Substance abuse.
  4. Intellectual disabilities.
  5. Unable to sign informed concent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02890316
Other Study ID Numbers  ICMJE 2370-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Merav Ben-David, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Technion, Israel Institute of Technology
Investigators  ICMJE
Principal Investigator: Merav Ben-David, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP