Aromatherapy for Integrated Cancer Care

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StatoReclutamento

Sponsor

University of Rochester

TEST CLINICO: NCT03449511

BioSeek: nct03449511

Parole chiave

Astratto

The purpose of this clinical trial is to determine the feasibility and effectiveness of aromatherapy in relief of commonly reported symptoms in cancer patients undergoing chemotherapy. Aromatherapy is a noninvasive, minimal risk intervention that could potentially alleviate the severity of treatment-related symptoms. This study will evaluate the ability of four aromatherapy scents (ginger, lavender, orange, jojoba) to reduce the severity of seven chemotherapy-induced symptoms (nausea, vomiting, pain, anxiety/distress, fatigue, sleep difficulties, and lack of appetite). Jojoba oil is a " carrier oil" and will act as a placebo comparator in this study. Jojoba oil is present in small amount (1 drop) in the ginger, lavender, and orange aromatherapy inhalers. As part of the study, the participants will be asked to use an aromatherapy inhaler, which resembles a lipstick container, during three chemotherapy cycles. The participants will use the aromatherapy inhaler for 7 consecutive days. The investigators will ask the participants questions regarding demographics, clinical information, current severity of symptoms, and current methods of symptom management. There is a non-intervention baseline cycle during which subjects rate the severity of the seven different symptoms from 0 to 10 for seven consecutive days during their first chemotherapy study cycle. The next two study cycles are intervention cycles using the randomized aromatherapy. The participants will rate the severity of seven different symptoms from 0 to 10 each day the aromatherapy inhaler during each of the three chemotherapy cycles (i.e., 7 consecutive days during each chemotherapy cycle). At the end of the study, the participants will be asked about his/her satisfaction with the aromatherapy used during the study. All of these measurements will provide a better understanding of the effectiveness of aromatherapy for symptom management.

Date

Ultimo verificato:	12/31/2019
Primo inviato:	02/21/2018
Iscrizione stimata inviata:	02/21/2018
Primo pubblicato:	02/27/2018
Ultimo aggiornamento inviato:	01/07/2020
Ultimo aggiornamento pubblicato:	01/09/2020
Data di inizio effettiva dello studio:	04/10/2018
Data di completamento primaria stimata:	12/30/2020
Data stimata di completamento dello studio:	01/30/2021

Condizione o malattia

Cancer

Intervento / trattamento

Other: Ginger aromatherapy

Other: Orange aromatherpy

Other: Lavender aromatherapy

Other: Jojoba aromatherapy

Fase

Gruppi di braccia

Braccio	Intervento / trattamento
Active Comparator: Ginger aromatherapy Ginger essential oil (GIN-106) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.	Other: Ginger aromatherapy Three sniffs of aromatherapy inhaler four times daily for seven days.
Active Comparator: Orange aromatherpy Orange essential oil (ORG-114) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.	Other: Orange aromatherpy Three sniffs of aromatherapy inhaler four times daily for seven days.
Active Comparator: Lavender aromatherapy Lavender essential oil (LAV-110) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.	Other: Lavender aromatherapy Three sniffs of aromatherapy inhaler four times daily for seven days.
Placebo Comparator: Jojoba aromatherapy Jojoba oil in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. One drop of jojoba oil is on the other three aromatherapy inhalers. Jojoba oil is a "carreir oil" for essential oils which will be used as a comparator and placebo in this study.	Other: Jojoba aromatherapy Three sniffs of aromatherapy inhaler four times daily for seven days.

Criteri di idoneità

Età idonea per lo studio	12 Years Per 12 Years
Sessi idonei allo studio	All
Accetta volontari sani	sì
Criteri	Inclusion Criteria: - a) Male and female subjects, at least 12 years of age, prescribed chemotherapy for cancer. (NOTE: Only non-pregnant females are eligible). University of Rochester will enroll young adults (i.e., 21-39 years) and adults (i.e., 40 years and older). RPCI will enroll adolescents (i.e., 12-20 years) and young adults (i.e., 21-39 years). b) Scheduled to receive three or more cycles of chemotherapy. (NOTE: Subjects may have already started chemotherapy, but must have at least three chemotherapy cycles remaining in their current prescribed course.) c) Day 1 of each chemotherapy cycle must be separated from Day 1 of the next chemotherapy cycle by at least 10 days. d) All cancer types and chemotherapy regimens are eligible. (NOTE: Monoclonal antibody therapies are allowed if administered in combination with chemotherapy). e) The chemotherapy regimen must be the same regimen for all study cycles. For example, if a subject with breast cancer was prescribed TAC for Study Cycle 1, the subject must receive TAC for Study Cycles 2 and 3. f) Any number of chemotherapy administrations per week during a chemotherapy treatment cycle is allowed. g) Subjects must agree to discontinue their current use of aromatherapy for symptom management during the course of the study. They must solely use the jojoba and aromatherapy inhalers provided by the study during the course of the study. h) Subjects must be able to read and understand English, as well as provide informed consent in order to participate in this study. Exclusion Criteria: - a) Subjects < 12 years old are not eligible for participation in this study. b) Pregnant females are ineligible for the study because pregnancy is a contraindication for chemotherapy and exposure to essentials oils. c) Subjects with more than six weeks between chemotherapy treatment cycles are not eligible. d) Concurrent radiation therapy or interferon treatment is not allowed. e) Subjects with any known allergy to ginger, lavender, orange, citrus of any kind, jojoba, or essential oils are not eligible.

Risultato

Misure di esito primarie

1. Number of participants that complete the intervention. [3 months]

Retention rate will be determined by arm.

2. Compliance rate [3 months]

The compliance rate is the percentage of participants that report using the aromatherapy as described in protocol (i.e., at least three sniffs four times daily).

Misure di esito secondarie

1. Mean composite severity score [3 months]

A composite symptom severity score will be calculated for each day during each Study Cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1.

2. Maximum composite severity score [3 months]

The maximum composite symptom severity score will be the highest severity score across the 6 days for that cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1.

Aromatherapy for Integrated Cancer Care

Parole chiave

ansia

cancro

fatica

nausea

vomito

simmondsia

simmondsia chinensis

chemioterapia