Effect of Iranian Traditional Medicine Remedy on Chemotherapy Induced Nausea and Vomiting

Mashhad University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Vomiting; Nausea

Treatments: Drug: Persumac; Drug: lactose

Study type: Interventional

Funder types: Other

Identifiers

NCT02787707

MashhadUMS

Details and patient eligibility

About

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.

Full 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:

1. 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.
2. 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.
3. 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.
4. (Wash out): Sixth day after the second session of chemotherapy until a day before the third session of chemotherapy determined as Wash out period.
5. In the third session of chemotherapy-in study, after obtaining the previous questionnaire, patient received cross over interventions. Questionnaire delivered to the patient again.

Enrollment: 69 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of breast cancer,
• Clinical diagnosis of chemotherapy induced nausea and vomiting resistant to conventional therapy.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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69 participants in 2 patient groups, including a placebo group

intervention

Active Comparator group

Description:

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.

Treatment:

Drug: Persumac

control

Placebo Comparator group

Description:

2.7 grams Lactose every 8 hour from 24 hour before to fifth day after chemotherapy.

Treatment:

Drug: lactose