Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Anxiety Disorders

Syndrome

Fatigue

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Dyspnea

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Respiration Disorders

Signs and Symptoms, Respiratory

Carcinoma, Bronchogenic

Bronchial Neoplasms

The primary aim of this study is to assess the effect of Qigong on managing dyspnea, fatigue, and anxiety (as a cluster) in lung cancer patients.

The secondary aim of this study is exploring the effect of Qigong on cough which is another common symptom linked with dyspnea, fatigue, and anxiety as a cluster, and QOL in lung cancer patients.

Qigong has long been regarded as a form of "mind-body" intervention in Traditional Chinese Medicine (TCM), which simultaneously exercises the "mind" and the "body" for treating many chronic diseases and promoting wellness. About a hundred million people are currently practicing Qigong in China. Qigong is now regarded as a form of self-practise mind-body exercise and recently relevant to sports activity, which is officially known as "Health Qigong". It is different from "Medical Qigong" which involves a TCM practitioner to emit "Qi" to heal the patients.

Qigong

Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung cancer patients: A randomized control trial

Background: Patients with lung cancer experience a variety of symptoms. The number of symptoms ranged from 7.8 to 13.2, and most of them were at a moderate level of severity. Dyspnea, fatigue, and anxiety arose as the most problematic symptoms of lung cancer. Non-pharmacological approaches to manage of symptom among lung cancer patients showed either no or mild effects. Qigong is hypothesized to alleviate these adverse outcomes; however, all trial analyzed on a single symptom, and not lung cancer patients, and there have not been many well-designed randomized control trials. The objectives of this study are following: 1) to assess the effect of Qigong on managing dypsnea, fatigue, and anxiety (as a cluster) in lung cancer patients; 2) to explore the effect of Qigong on cough another common symptom linked with dyspnea, fatigue as a cluster and quality of life (QOL) in lung cancer patients.

Methods: 156 subjects with lung cancer (stage I - IV) will be randomized to either the Qigong group or the wait-list control group. Participants in the Qigong group will conduct Qigong practice 5 times per week for 6 weeks, and participants in the control group will receive usual care. The primary outcome (dypsnea, fatigue, and anxiety), secondary outcomes (cough and QOL) will be assessed at baseline, post-intervention, and post 6-weeks of follow-up.

Discussion: This study will be the first randomized trial to investigate the effectiveness of Qigong for management symptom cluster in lung cancer patients. The finding of this study will help to establish the optimal approach for the care of lung cancer patients.

The design of this study was a randomized controlled trial (RCT) with two parallel groups in a 1:1 allocation ratio, allocation concealment, and assessor blinding.

In the current study, based on nature of the intervention, blinding was not feasible with researcher, statistician, Qigong master who were responsible for recruitment of subject, randomization, deliver the intervention. However, the investigators who collect the outcome information were blinded to the allocation sequence.

Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.

* Dyspnea is described as "an uncomfortable awareness of breathing" (DiSalvo, Joyce, Tyson, Culkin, \& Mackay, 2008). Cancer Dyspnoea Scale will be used to measure dypsnea in this study.
* Fatigue is defined as "a subjective feeling of tiredness, weakness or lack of energy" (Radbruch et al., 2008). Functional Assessment of Cancer Therapy-Fatigue (FACT-F) (Yellen et al., 1997) will be used to measure fatigue in this study.
* Anxiety is defined as "The apprehensive anticipation of future danger or misfortune accompanied by a feeling of dysphoria or somatic symptoms of tension" (American Psychiatric Association, 2005). The Anxiety subscale of the Depression, Anxiety, and Stress Scale 21 (DASS-21) (Sharp et al., 2013) will be used to measure anxiety in this study.

Cough is "a forced expulsive manoeuvre, usually against a closed glottis and which is associated with a characteristic sound" (McGarvey \& Morice, 2006; Pavord \& Chung, 2008). Manchester Cough in Lung Cancer Scale (MCLCS) (Molassiotis et al., 2012) will be used to measure cough in this study.

The World Health Organization (WHO) defined health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". European Organization for Research and Treatment of Cancer -Quality of life questionnaire - Core and Lung module (Fayers et al., 2012) will be used to measure quality of life in this study.

The Hong Kong Polytechnic University

Nam Dinh University of Nursing

Senior lecturer

Recurrence

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Nivolumab

Ibrutinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Ibrutinib administered by mouth daily in 28 day cycles.

Nivolumab administered by vein beginning with cycle 2, and given on Days 1 and 15 of every 28 day cycle.

560 mg given by mouth daily in a 28 day cycle.

3 mg/kg by vein beginning with Cycle 2 on Days 1 and 15 of every 28 day cycle.

John Heymach, MD, PHD

The goal of this clinical research study is to learn if Imbruvica (ibrutinib) alone and then in combination with Opdivo (nivolumab) can control NSCLC in patients who have received previous chemotherapy treatment.

Study Drug Administration:

Each study cycle will be 28 days.

If you are found to be eligible to take part in this study, during Cycle 1, you will take ibrutinib alone. Ibrutinib should be taken by mouth 1 time each day with a glass of water. You should take the study drug at the same time every day. You may take your dose of ibrutinib with or without food.

If you miss a dose, take it as soon as possible on the same day with a return to the normal schedule the following day. You should not take any extra doses on the following day to make up for any forgotten doses.

Beginning with Cycle 2, you will receive nivolumab by vein over 60 minutes on Days 1 and 15 of every cycle. You will continue to take ibrutinib as you did during Cycle 1.

You will be given a pill diary to complete. You should record in the diary each dose of medication you take and when you took it. You should bring this diary with you to each study visit.

Study Visits:

On Day 1 (+/- 7 days) of all cycles:

* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests.

Between Days 21 and 28 of Cycle 1:

* You will have a tumor biopsy for biomarker testing and to check your immune system's response to the study drug.
* Blood (about 1-2 teaspoons) will be drawn for cytokine/chemokine testing.

On Day 28 of Cycle 1 only, you will have a CT of the neck and chest to check the status of the disease.

On Day 28 (+/- 7 days) of Cycle 1 and then every 8 weeks after that:

* Blood (about 1 teaspoon) will be drawn to check your thyroid function.
* You will have a CT or MRI scan to check the status of the disease.

If you can become pregnant, you may have a blood (about 1 teaspoon) or urine pregnancy test at any time the doctor thinks it is needed.

Length of Study:

You may receive ibrutinib for up to 2 years. You may receive nivolumab for as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow up:

Within 30 days after the last dose of study drug:

* You will have a physical exam.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* If you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.

Long-term follow up:

Every 6 months for up to 2 years after your first dose of study drug:

* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests.

This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). It is considered investigational to use this drug to treat NSCLC. Nivolumab is FDA approved and commercially available for the treatment of advanced NSCLC. The study doctor can explain how the study drugs are designed to work.

Up to 25 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Non-Small Cell Lung Cancer (NSCLC)

A Phase II Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Advanced Non-Small Cell Lung Cancer

Response rate defined as the sum of complete plus partial responses (CR+PR).

Response assessed by RECIST 1.1 criteria.

Disease control rate defined as rate of stable disease + partial response + complete response.

Outcome measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Qigong on the Symptom Clusters of Dyspnea, Fatigue, and Anxiety.	NCT02977845	Lung Cancer, No... Lung Cancer Non... Lung Cancer, No... Lung Cancer Non... Lung Cancer, Li...	Qigong	18 Years -	Nam Dinh University of Nursing
Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Non-Small Cell Lung Cancer (NSCLC)	NCT02950038	Lung Cancer, No...	Ibrutinib Nivolumab	18 Years -	M.D. Anderson Cancer Center
Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Non-Small Cell Lung Cancer (NSCLC)	NCT02950038	Lung Cancer, No...	Ibrutinib Nivolumab	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for lung cancer, nonsmall cell, stage i