跳至主要内容
临床试验/NCT06950632
NCT06950632尚未招募不适用

Effect of Peppermint Oil Inhalation on Intensity and Frequency of Acute Nausea and Vomiting in Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial

University of Health Sciences Lahore1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
106
试验地点
1
主要终点
Effect of Peppermint Oil Inhalation on the Intensity and Frequency of Acute Nausea and Vomiting Measured by RINV Scale

研究概览

简要总结

Cancer is a major cause of death and disability worldwide and in South Asian countries. Cancer treatment options include chemotherapy, radiation therapy, surgery, and adjuvant therapy (Additional treatments after primary cancer treatment such as surgery, radiation, or chemotherapy are used to lower the chance of cancer recurrence or remove any remaining cancer cells). Chemotherapy poses serious adverse effects, including fatigue, hair loss, skin irritation, loss of appetite, change in bowel habits, weakened immune system, dry mouth, peripheral neuropathy, nausea and vomiting. Chemotherapy-induced nausea and vomiting cause fluid-electrolyte imbalance, dehydration, weight loss and physiological consequences due to inadequate medication absorption or compromised kidney clearance. Although anti-emetic drugs are given to reduce CINV but these drugs pose some serious adverse effects including heartburn, insomnia, headache, dizziness, constipation/diarrhea, loss of muscle control, pharyngeal itching, dry mouth and also increases economic burden on the patient and his/her family. The limited and hazardous side effects of these medications have led to a shift towards non-pharmacological and home remedies. Using natural remedies is a simple and low-risk measure in this regard. This study aims to evaluate the effects of peppermint oil inhalation on the intensity and frequency of Chemotherapy induced acute nausea and vomiting among cancer patients undergoing chemotherapy. A randomized controlled trial will be conducted using non-probability convenience sampling, followed by random assignment to intervention and control groups. The target population comprises patients receiving chemotherapy at the outpatient oncology department of Jinnah Hospital, Lahore. A total of 106 patients will be enrolled. The intervention group will receive peppermint oil inhalation, while the control group will receive a placebo. Descriptive statistics (frequency, percentage, mean, and standard deviation) will be used to summarize participant's characteristics. Chi-square test will be applied to compare demographic variables (e.g., age, gender, marital status, education, occupation, and RINV categories) between groups. An independent t-test will be used to compare the mean RINV scores post-intervention between intervention and control group. A p-value of <0.05 will be considered statistically significant. It is anticipated that peppermint oil inhalation will significantly reduce the severity and frequency of Chemotherapy induced acute nausea and vomiting. If effective, this complementary intervention could offer a low-cost, safe alternative to supplement standard anti-emetic therapies, potentially easing the financial and physiological burden associated with pharmacological treatments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• Participants undergoing chemotherapy in the outpatient oncology department of Jinnah Hospital Lahore.
  • •Participants ages 20-50 years.
  • •Participants of Both genders' male and female.
  • •Participants who have undergone under one cycle of chemotherapy.
  • •Participants who can understand and comprehend Urdu and Punjabi language

排除标准

  • •Participants who are allergic to peppermint products.
  • •Participants who have any psychiatric illness.
  • •Participants diagnosed with any respiratory illness.
  • •Participants who have vomiting due to any ailment other than chemotherapy.
  • •Participants with Gastro-intestinal and Hepatobiliary Tumors.

研究组 & 干预措施

Peppermint oil inhalation

Experimental

Participants in the experimental group will inhale five drops of 100% pure peppermint essential oil placed on a cotton ball inside a container for ten minutes before each chemotherapy session and every two hours during the infusion

干预措施: Pepppermint oil inhalation (Dietary Supplement)

Control group

Sham Comparator

The control group will inhale five drops of distilled water placed on a cotton ball inside a container for ten minutes before each chemotherapy session and every two hours during the infusion

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Effect of Peppermint Oil Inhalation on the Intensity and Frequency of Acute Nausea and Vomiting Measured by RINV Scale

时间窗: Within 24 hours after chemotherapy (acute phase)

The primary outcome is the change in the intensity and frequency of acute nausea and vomiting, assessed by the Rhodes Index of Nausea, Vomiting, and Retching (RINV) Scale, within 24 hours following chemotherapy. Comparison of mean RINV scores will be made between the experimental (peppermint oil inhalation) group and the control group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

QURAT-UL-AIN

Qurat-Ul-Ain

University of Health Sciences Lahore

研究点 (1)

Loading locations...

相似试验