NauseaPhase 2NCT02787707
Effect of Iranian Traditional Medicine Remedy on Chemotherapy Induced Nausea and Vomiting
A Phase 2 study testing Persumac and lactose in people with Nausea and Vomiting, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The main objective of this research is the role of the Persumac(an Iranian traditional remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting in acute and delayed phase. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- What is being tested?
- Persumac and lactose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteIran
- Study dates
- Oct 2015to May 2016
- Phase
- Phase 2
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of breast cancer,
- Clinical diagnosis of chemotherapy induced nausea and vomiting resistant to conventional therapy.
Who cannot join
- Clinical diagnosis of hypersensitivity to Sumac or Bunium Persicum,
- Clinical diagnosis of digestion disorders,
- Clinical diagnosis of non chemotherapy induced nausea and vomiting,
- Milk allergy,
- Clinical diagnosis of bleeding diathesis,
- Clinical diagnosis of non-breast cancer.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province
About this study
Official title: ٍEffect of Iranian Traditional Medicine Remedy Compared With Placebo on Chemotherapy Induced Nausea and Vomiting in Breast Cancer; a Double-blind Randomized Controlled Cross-over Clinical Trial
The main objective of this research is the role of the Persumac(an Iranian traditional remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting in acute and delayed phase.
Read the detailed description
The study was a double-blind, placebo controlled, Cross-over clinical trial of Iranian traditional remedy (Persumac) on chemotherapy induced nausea and vomiting in breast cancer patients. From October 2015 to May 2016, sample selection continued to be until the full sample size.
Executive steps of study:
- Among patients referred for breast cancer, to the oncology clinic in Imam Reza hospital in Mashhad University of Medical Sciences, an oncology referral center in the North East of Iran; patients included in study who had at least one chemotherapy session and remain at least three sessions of Their chemotherapy cycle and had inclusion criteria.
- The initial assessment of patients (Run- in): Concurrent with the visit of patient for chemotherapy (the first session of her/his chemotherapy in this study); during interview, study questionnaire was delivered to patient. It took a full explanation of how to complete it and return the next session.
- In the second session of chemotherapy (in study); after eligibility qualification and obtaining consent form, patients randomly allocated into intervention and control groups, In accordance with the study protocol, interventions take place. Questionnaire was delivered to the patient again.
- (Wash out): Sixth day after the second session of chemotherapy until a day before the third session of chemotherapy determined as Wash out period.
- In the third session of chemotherapy-in study, after obtaining the previous questionnaire, patient received cross over interventions. Questionnaire delivered to the patient again.
- Being tested
- Persumac, lactose
- Keywords
- Breast cancer, Traditional medicine, Chemotherapy Induced Nausea and Vomiting, Bunium Persicum, Rhus Coriaria
- Medical subject headings
- Nausea, Vomiting, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PersumacDrug
Also called Sumac and black Zirah
2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour
lactoseDrug
Also called Lactose powder
2.7 grams Lactose every 8 hour
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | 2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour from 24 hour before to fifth day after chemotherapy. Receives: Drug: Persumac |
| control | Placebo comparator | 2.7 grams Lactose every 8 hour from 24 hour before to fifth day after chemotherapy. Receives: Drug: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity of nausea and vomiting in acute phase
number and severity of nausea and vomiting, acquired from questionnaire
Measured: first 24 hour after chemotherapy
Secondary outcomes (1)
Frequency and Severity of nausea and vomiting in acute phase
number and severity of nausea and vomiting, acquired from questionnaire
Measured: Day 2-5 of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionMay 2016
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 NauseaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadegh Shokri, Mashhad University of Medical Sciences
- Investigators
- Mohammad Nazari, Ph.D, Study director, School of Persian and Complementary medicine, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787707
- Sponsor's protocol ID
- MashhadUMS
- Status last verified
- Jun 2016
- First submitted
- 19 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publication
Publications
Nazari M, Taghizadeh A, Bazzaz MM, Rakhshandeh H, Shokri S. Effect of Persian Medicine Remedy on Chemotherapy Induced Nausea and Vomiting in Breast Cancer: A Double Blind, Randomized, Crossover Clinical Trial. Electron Physician. 2017 Jan 25;9(1):3535-3543. doi: 10.19082/3535. eCollection 2017 Jan.
PubMed 28243404
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ٍEffect of Iranian Traditional Medicine Remedy Compared With Placebo on Chemotherapy Induced Nausea and Vomiting in Breast Cancer; a Double-blind Randomized Controlled Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT02787707
- Acronym / sponsor ID
- MashhadUMS
- Keywords
- Breast cancer, Traditional medicine, Chemotherapy Induced Nausea and Vomiting, Bunium Persicum, Rhus Coriaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Jun 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.
The main objective of this research is the role of the Persumac(an Iranian traditional remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting in acute and delayed phase.
Detailed description
The study was a double-blind, placebo controlled, Cross-over clinical trial of Iranian traditional remedy (Persumac) on chemotherapy induced nausea and vomiting in breast cancer patients. From October 2015 to May 2016, sample selection continued to be until the full sample size.
Executive steps of study:
- Among patients referred for breast cancer, to the oncology clinic in Imam Reza hospital in Mashhad University of Medical Sciences, an oncology referral center in the North East of Iran; patients included in study who had at least one chemotherapy session and remain at least three sessions of Their chemotherapy cycle and had inclusion criteria.
- The initial assessment of patients (Run- in): Concurrent with the visit of patient for chemotherapy (the first session of her/his chemotherapy in this study); during interview, study questionnaire was delivered to patient. It took a full explanation of how to complete it and return the next session.
- In the second session of chemotherapy (in study); after eligibility qualification and obtaining consent form, patients randomly allocated into intervention and control groups, In accordance with the study protocol, interventions take place. Questionnaire was delivered to the patient again.
- (Wash out): Sixth day after the second session of chemotherapy until a day before the third session of chemotherapy determined as Wash out period.
- In the third session of chemotherapy-in study, after obtaining the previous questionnaire, patient received cross over interventions. Questionnaire delivered to the patient again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Drug: Persumac2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour from 24 hour before to fifth day after chemotherapy. |
| control | Placebo comparator | Drug: lactose2.7 grams Lactose every 8 hour from 24 hour before to fifth day after chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of breast cancer,
- Clinical diagnosis of chemotherapy induced nausea and vomiting resistant to conventional therapy.
Key exclusion criteria (6 listed)
- Clinical diagnosis of hypersensitivity to Sumac or Bunium Persicum,
- Clinical diagnosis of digestion disorders,
- Clinical diagnosis of non chemotherapy induced nausea and vomiting,
- Milk allergy,
- Clinical diagnosis of bleeding diathesis,
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 |
|---|---|---|
| PersumacAlso: Sumac and black Zirah2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour | Drug | intervention |
| lactoseAlso: Lactose powder2.7 grams Lactose every 8 hour | Drug | control |
Primary outcome
Frequency and Severity of nausea and vomiting in acute phase
Time frame: first 24 hour after chemotherapy
number and severity of nausea and vomiting, acquired from questionnaire
1 secondary outcome
Frequency and Severity of nausea and vomiting in acute phase
Time frame: Day 2-5 of chemotherapy
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 3 Jun 2016.
- Derived from this study: PubMed 28243404Nazari M, Taghizadeh A, Bazzaz MM, Rakhshandeh H, Shokri S. Effect of Persian Medicine Remedy on Chemotherapy Induced Nausea and Vomiting in Breast Cancer: A Double Blind, Randomized, Crossover Clinical Trial. Electron Physician. 2017 Jan 25;9(1):3535-3543. doi: 10.19082/3535. eCollection 2017 Jan.
- Individual participant dataSharing planned: Yes. Publication
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Nausea, Vomiting
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.
Mohammad Nazari, Ph.D study director
School of Persian and Complementary medicine, Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Persumac and lactose in people with Nausea and Vomiting, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 6 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 3 Jun 2016. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency and Severity of nausea and vomiting in acute phase (time frame: first 24 hour after chemotherapy). 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 NCT02787707, 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 3 Jun 2016.