Chemotherapy Symptoms Clinical Trial
Official title:
Aromatherapy for Management of Chemotherapy-induced Symptoms
| Verified date | January 2019 |
| Source | University of Rochester |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The rationale behind the proposed study is to determine the initial effectiveness of aromatherapy in relief of commonly reported symptoms in cancer patients undergoing chemotherapy.
| Status | Terminated |
| Enrollment | 31 |
| Est. completion date | September 12, 2018 |
| Est. primary completion date | September 12, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 89 Years |
| Eligibility |
Inclusion Criteria: - Non-pregnant adults between the ages of 21 to 89 years of age with diagnosis of cancer and be scheduled to receive at least three more cycles of chemotherapy. - Subjects must have had at least one chemotherapy cycle in their current prescribed course and have at least three additional chemotherapy cycles planned. - Day 1 of each chemotherapy cycle must be separated from Day 1 of the next chemotherapy cycles by at least 12 days. - All chemotherapy regimens are eligible. - Any number of chemotherapy administrations per week during a chemotherapy treatment cycle is allowed. - Subjects agree to discontinue any current aromatherapy usage and only use the study aromatherapy for symptom management during the course of the study. NOTE: Patients can continue to use scented soaps, lotions, shampoos, body sprays, perfume/cologne, candles, or air fresheners that they regularly use. - Subjects must be able to read and understand English, as well as provide informed consent in order to participate in this study. Exclusion Criteria: - Subjects < 21 years old or > 89 years old are not eligible for participation in this study at the University of Rochester. - Pregnant females are ineligible for the study because pregnancy is a contraindication for chemotherapy and exposure to essentials oils. - Subjects who are chemotherapy-naïve are ineligible. - Subjects with more than four weeks between chemotherapy treatment cycles are not eligible. - Concurrent radiation therapy or interferon treatment is not allowed. - Subjects that have used or are currently using aromatherapy inhalation for symptom management are not eligible. - Subjects with any known allergy to ginger, lavender, orange, citrus of any kind, jojoba, or essential oils. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Rochester Medical Center, Wilmot Canter Center | Rochester | New York |
| Lead Sponsor | Collaborator |
|---|---|
| University of Rochester |
United States,
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* Note: There are 26 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in severity in symptoms | Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format. | up to 11 weeks | |
| Secondary | change in mean peak severity for nausea across all three cycles | Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format. | up to 11 weeks | |
| Secondary | change in mean peak severity for vomiting across all three cycles | Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format. | up to 11 weeks | |
| Secondary | change in mean peak severity for anxiety/distress across all three cycles | Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format. | up to 11 weeks | |
| Secondary | change in mean peak severity for pain across all three cycles | Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format. | up to 11 weeks | |
| Secondary | change in mean peak severity for fatigue across all three cycles | Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format. | up to 11 weeks | |
| Secondary | change in mean peak severity for sleep difficulties across all three cycles | Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format. | up to 11 weeks | |
| Secondary | change in mean peak severity for lack of appetite across all three cycles | Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format. | up to 11 weeks | |
| Secondary | the number of participants who found the aromatherapy acceptable | The following questions will be asked of the subjects to obtain qualitative feedback to further evaluate acceptability of the aromatherapy inhalers: 1) What two things did you like about your aromatherapy inhaler?; 2) What two things did subjects dislike about the aromatherapy inhaler?; 3) Was the aromatherapy inhaler easy to use?; 4) Did subjects feel that the aromatherapy inhaler reduced symptoms from chemotherapy? Please circle the symptoms that seemed to be helped the most.; 5) Would the subject use this aromatherapy inhaler again in the future?; 6) Would the subject recommend this aromatherapy inhaler to others?; 7) What word or statement would the subject use to describe their experience during this clinical trial?; and 8) What intervention arm do subjects think they were in? All of these data will help determine if the aromatherapy inhalers and scents are acceptable and feasible to use for in cancer subjects during chemotherapy. | up to 11 weeks |