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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

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

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Homeopathy remedy Radiation: Radiation as adjuvant therapy for breast cancer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive and Emotional Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
Study Start Date : July 2016
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
Radiation: Radiation as adjuvant therapy for breast cancer
Daily radiation therapy.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890316


Locations
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Israel
Merav Ben David
Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Technion, Israel Institute of Technology
Investigators
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Principal Investigator: Merav Ben-David, MD Sheba Medical Center
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Responsible Party: Dr. Merav Ben-David, Head, Breast Radiation Unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02890316    
Other Study ID Numbers: 2370-15
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases