Herbal and Botanical

All Drugs and Chemicals

Orange

Ginger

English Lavender

Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).

The ginger oil (GIN-106) was steam distilled from fresh ginger grown in Madagascar. The ginger oil contains 64.23% sesquiterpenes, 18.5% monoterpenes, and 3.28% aldehydes. The aroma of ginger is described as spicy, sweet, and warm.

The lavender oil (LAV-110) was steam distilled from lavender grown in Kashmir Valley in India. The lavender oil contains 53.22% esters, 31.86% monoterpenols, and 4.88% oxides. The aroma of lavender is described as floral, fresh, herbaceous, and sweet.

Lavender

The orange oil (ORG-114) was cold-pressed and steam distilled from oranges in South Africa. The orange oil contains 97.21% monoterpenes, 0.73% aldehydes, and 0.7% monoterpenols. The aroma of orange is described as citrus, fresh, fruity, and sweet.

The jojoba oil is certified organic and pesticide-free pure oil. Jojoba has a mild scent and can be used as a "fixative" for other essential oils.

Jojoba

Julie Ryan, PhD, MPH

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.

The proposed study is an exploratory trial to evaluate the use of aromatherapy for symptom management in patients undergoing chemotherapy. The investigators will accrue 120 adult cancer subjects undergoing chemotherapy in a initial efficacy study to determine the effectiveness of three different aromatherapies (ginger, lavender, or orange) on chemotherapy-related symptoms (nausea, vomiting, pain, anxiety, sleep difficulties, fatigue, and lack of appetite) compared to placebo (i.e., jojoba). All subjects will be randomized to one of the four arms for symptom management during three different chemotherapy cycles. The investigators will examine the incidence and severity of the seven symptoms at each chemotherapy cycle. The preliminary data from this study will elucidate the relationships between certain aromatherapies and specific symptom relief, which can be further evaluated in a larger confirmatory study of subjects undergoing chemotherapy or other types of cancer treatment. This study will provide clinical evidence regarding the incorporation of aromatherapy into cancer patient care.

Aromatherapy for Chemotherapy-induced Symptoms

Aromatherapy for Management of Chemotherapy-induced 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.

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.

University of Rochester

Assistant Professor of Dermatology

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Lung Neoplasms

Neurobehavioral Manifestations

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Study participants with advanced-stage lung cancer.

Surveys about symptoms, mood, and quality of life.

Questionnaire

Automated telephone system call once a week during therapy, rating of severity of symptoms and daily life interference done with numeric key pad. Post therapy is complete, a call every two weeks for up to six months.

Telephone Interactive System

For participating patients, 3 additional tablespoons of blood drawn at the beginning of each chemotherapy treatment (before treatment starts) and at the beginning of each cycle of treatment.

Blood Samples

Xin Shelley Wang, MD

Primary Objectives:

* To compare the severity of symptoms, their impact on affective and health-related functional status, and symptom interference among patients with advanced-stage lung cancer following initiation of chemotherapy by disease status, tumor response to chemotherapy, and adequacy of symptom management.
* To examine the relationship of disease-related and treatment-related physical symptoms to affective impairment and the patient's reported symptom interference and functional impairment.
* To compare symptom severity, adequacy of symptom management, and interference with affective status and health-related function by patient's minority status.
* To explore the serum level of inflammatory cytokines during chemotherapy among lung cancer patients.
* To measure DNA repair capacity (DRC) in lymphocyte cultures of all patients enrolled in the protocol at baseline (before treatment) and during each follow-up blood draw. The hypothesis is that patients with suboptimal DRC will do better with chemotherapy than patients with efficient DRC.
* To extract DNA and genotype for polymorphisms in genes involved in the nucleotide excision repair pathway and in those involved in response to pain (opioid receptors, dopamine receptors, COMT). We hypothesize that:

  1. Polymorphisms in NER genes that modulate DNA repair capacity will also effect response to chemotherapy and to outcome.
  2. Cytokine gene polymorphisms account for variations in symptom outcomes (specific symptoms and symptom clusters) before, during and after chemotherapy.
  3. The COMT val/met polymorphism affects the metabolism of catecholamines on the modulation of response to sustained pain.
  4. Dopamine receptor polymorphisms that result in decreased density of dopamine receptors will result in a deficit in the dopamine pathway. that will also affect response to pain.
* To evaluate neurocognitive function to determine the prevalence, severity, and pattern of cognitive symptoms.

One of the ways to learn about the symptoms of chemotherapy is by looking at how certain proteins called cytokines (found in the blood) change during therapy. Another way is to look at how symptoms change during treatment.

Before therapy starts, you will be asked to complete several questionnaires during a visit to the thoracic clinic at M. D. Anderson. These questionnaires measure physical and emotional (mental) symptoms. The questionnaires should take about 60 minutes to finish. You will also be asked to complete some cognitive (mental) questionnaires that take about 25 minutes to complete. During this visit, the research nurse will teach you how to use an interactive voice response telephone system for measuring symptoms. The research nurse will ask you the most convenient time for the telephone calls, and make sure the system is programmed to call you at that time. The date of the call will be at the same or close to the date of your weekly clinic visit.

Symptoms will be monitored weekly during chemotherapy treatment using this interactive voice response telephone system. The automated telephone system will call you once a week, and using the numeric key pad on your telephone, you will rate the severity of your symptoms and how much they interfere in your daily life. Once you complete therapy, the phone system will call every two weeks for up to six months. The information collected by these calls is only being used for this research study.

In addition to the telephone calls, the research nurse will arrange to meet you approximately every 6 weeks at your clinic visit. She will ask you to complete some surveys about your symptoms, mood, and quality of life. This meeting will take about 45 minutes. You will also be asked again to complete some cognitive (mental) questionnaires that take about 25 minutes to complete.

Research staff will also obtain from your medical record clinical information and lab values during your treatment period.

If you have agreed to participate in the companion caregiver study, the study staff will use your demographic and clinical data to study the influence of your symptoms on your caregiver's physical and mental health.

You are encouraged to report your symptoms to your treating physicians during the study, especially if you have any symptom that you rate greater than 7 on the 0 to 10 scale.

This is an investigational study. A total of up to 224 patients will take part in this multicenter study. Up to 112 will be enrolled at M. D. Anderson.

Study participants enrolled at M. D. Anderson will have additional serum drawn for cytokine analysis and DNA repair capacity. This blood will be drawn at the routine blood draws before treatment begins, and at the beginning of each treatment cycle.

Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer

Longitudinal Study of the Prevalence, Severity, and Interference of Multiple Symptoms in Advanced Lung Cancer

IVR telephone system to collect longitudinal data on symptom patterns and severity using patient tumor response evaluation after 2-3 cycles chemotherapy and total weekly IVR assessment period at 18 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aromatherapy for Chemotherapy-induced Symptoms	NCT02670941	Chemotherapy Sy...	Ginger Lavender Orange Jojoba	21 Years - 89 Years	University of Rochester
Aromatherapy for Chemotherapy-induced Symptoms	NCT02670941	Chemotherapy Sy...	Ginger Lavender Orange Jojoba	21 Years - 89 Years	University of Rochester
Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer	NCT00422500	Lung Cancer	Questionnaire Telephone Inter... Blood Samples	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for chemotherapy symptoms