Breast CancerNCT02890316
Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
A study testing Homeopathy remedy and Radiation as adjuvant therapy for breast cancer in people with Breast Cancer, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive and emotional functions. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Homeopathy remedy and Radiation as adjuvant therapy for breast cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncontrolled hypertension.
- Participating in another clinical study with active treatment
- Substance abuse.
- Intellectual disabilities.
- Unable to sign informed concent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive and Emotional Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive and emotional functions.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Homeopathy remedy, Radiation as adjuvant therapy for breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathy remedyOther
Homeopathy remedy, prescribed by a physician and prepared by licensed pharmacy.
Radiation as adjuvant therapy for breast cancerRadiation
Daily radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Homeopathy remedy; Radiation: 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. Receives: Radiation: Radiation as adjuvant therapy for breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1, 16, 33 of radiation therapy
Secondary outcomes (1)
Physiological monitoring of changes in attention during radiotherapy with and without homeopathy treatment.
An interview assessing the changes attention with the Fatigue Symptom Inventory scale.
Measured: Days 1, 16, 33 of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Dr. Merav Ben-David, Sheba Medical Center
- Investigators
- Merav Ben-David, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890316
- Sponsor's protocol ID
- 2370-15
- Status last verified
- Apr 2019
- First submitted
- 19 Jul 2016
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 34027702
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Emotional Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
- ClinicalTrials.gov ID
- NCT02890316
- Acronym / sponsor ID
- 2370-15
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Jul 2016
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy with Homeopathy | Experimental | Other: Homeopathy remedy, Radiation: Radiation as adjuvant therapy for breast cancerPatients 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. |
| Radiation therapy with placebo | Placebo comparator | Radiation: Radiation as adjuvant therapy for breast cancerPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- Uncontrolled hypertension.
- Participating in another clinical study with active treatment
- Substance abuse.
- Intellectual disabilities.
- Unable to sign informed concent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeopathy remedyHomeopathy remedy, prescribed by a physician and prepared by licensed pharmacy. | Other | Radiation therapy with Homeopathy |
| Radiation as adjuvant therapy for breast cancerDaily radiation therapy. | Radiation | Radiation therapy with Homeopathy, Radiation therapy with placebo |
Primary outcome
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.
1 secondary outcome
Physiological monitoring of changes in attention during radiotherapy with and without homeopathy treatment.
Time frame: Days 1, 16, 33 of radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 34027702Dolev 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merav Ben-David, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homeopathy remedy and Radiation as adjuvant therapy for breast cancer in people with Breast Cancer, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological monitoring of changes in anxiety during radiotherapy with and without homeopathy treatment. (time frame: Days 1, 16, 33 of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.