Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Sarcopenia

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.

Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.

Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake.

Nutritional Counseling

Standard Exercise

Enhanced Exercise

Elizabeth Hile, PhD, PT

This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research design are feasible in this population. We also aim to determine if physical function or quality of life can be improved with only 2-3 weeks of prehabilitation. This is in preparation for a larger study to determine if resistance improves outcomes.

This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to surgical resection, using a home-based exercise program with all equipment provided, and following nutritional recommendations. Intervention begins when the oncologist determines that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery. Participants in both arms are asked to perform moderate exercise daily, targeting a total of 60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and progressed according to tolerance. Initial prescription is individualized according to the patient's baseline level of exercise and functional status. Patients record their exercise and wear an accelerometer to track activity if willing. All participants receive follow-up phone calls from an exercise specialist for adherence and assistance with progression. The intervention period ends at the time of surgery.

In this 'quasi-double blinded' randomized trial, participants are not told the difference between the two exercise interventions, and randomization to the two treatment arms is stratified by baseline functional status, such that patients deemed to be 'borderline' in fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed and recorded.

Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT

The percentage of eligible patients enrolled

Retention as the percentage of enrolled patients retained assessment point

Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls

Quality of life will be assessed using Functional Assessment of Cancer Therapy General Scale (FACT-G) during the pre-operative period (V1-V2). Scale is 0-108. The higher the score, the better the score.

Change in baseline body weight in pounds during the pre-operative period (V1-V2)

Change in baseline body weight in pounds at second post operative visit

Six-Minute Walk Test in meters during the pre-operative period (V1-V2). The Six Minute Walk test will be performed according to American Thoracic Society Guidelines.

Grip Strength . with a Jamar handgrip dynamometer .

Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery.

Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.

Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).

University of Oklahoma

Behaviors and Mental Disorders

Respiratory Tract (Lung and Bronchial) Diseases

Anxiety Disorders

Depressive Disorder

Carcinoma

Carcinoma, Non-Small-Cell Lung

Depression

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

See methods below - standard strength and endurance training

See methods below - medical QiGong therapy session

The standard exercise therapy program will include 12 treatments of approximately 45 minutes duration, twice a week for a period of six weeks by the same instructor and at the same location as for Qigong therapy. This exercise program is supervised and consists of cardio-vascular and resistance training exercises. Participants are asked to refrain from practicing Qigong during this 6 week period.

Qigong therapy will be led by a trained Qigong instructor and will occur for 45 minutes sessions, twice a week for a period of six weeks. Qigong is a self-directed walking exercise program that involves arm movements that are coordinated with slight movements of the waist, while in a state of deep relaxation or meditation. Patients will be asked to refrain from independent resistance or cardiovascular training during this 6 week period.

Qigong Exercise

Thomas Jagoe, MD, PhD

Cancer patients face a number of symptoms related to treatment or disease which may impair quality of life, such as decreased functional capacity, fatigue, nausea an vomiting, distress, depression and unmet psychological needs. Due to this array of symptoms, cancer patients often seek supportive complementary and alternative medicine, which many patients use along with conventional treatments. Qigong, a type traditional chinese medicine, is a mind-body exercise that combines meditation, slow physical movements, and controlled breathing. The investigators hypothesise that Qigong therapy is better in the reduction of anxiety and depression levels and the improvement of quality of life in patients with lung and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to standard exercise training.

Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy

Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy

Peer-reviewed manuscripts and conference proceedings

Depression and anxiety will be measured using the Hospital Anxiety Depression Scale (HADS); The HADS is a 14-item self-rated questionnaire, consisting of two 7-item subscales. It was developed to identify anxiety and depression in non-psychiatric medical outpatients. Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress). The HADS will be administered within 2 weeks of completing each exercise program.

The general version of the Functional Assessment of Cancer Therapy scale (FACT-G) will be used to measure Quality of Life (QoL) after completion of each 6 week exercise program. This questionnaire consists of 4 subscales: Physical well-being (PWB), Social well-being (SWB), Emotional well-being (EWB) and Functional well-being (FWB). A change of 4 points on the total FACT score is regarded as clinically significant.

Functional capcity will be measured using the Simmonds Functional Assessment (SFA) within 2 weeks of finishing each 6-week exercise program. This tool consists of eight items: putting on a sock, tying a belt, putting coins in a cup, reaching forward, repeated reach up (3 times), repeated sit to stand (2 times), speed walk for 50 feet, and walking for 6 minutes. Patient satisfaction will be measured by asking all participants to answer a two item questionnaire with a 10-point visual analog scale response option.

Symptoms commonly reported by lung and GI cancer patients will be measured using the Edmonton Symptom Assessment Scale (ESAS). The ESAS is a 12-item patient rated symptom questionnaire scored using a 10-point visual analogue scale. The ESAS will be administered within 2 weeks of completing each 6-week exercise program.

Patient satisfaction will be measured by asking all participants to answer a two-item questionnaire after they have completed each 6-week exercise program.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exercise and Nutrition to Improve Pancreatic Cancer Outcomes	NCT03256201	Pancreatic Canc...	Nutritional Cou... Standard Exerci... Enhanced Exerci...	30 Years -	University of Oklahoma
Exercise and Nutrition to Improve Pancreatic Cancer Outcomes	NCT03256201	Pancreatic Canc...	Nutritional Cou... Standard Exerci... Enhanced Exerci...	30 Years -	University of Oklahoma
Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy	NCT01374100	Carcinoma, Non-... Cancer of the G...	Standard Exerci... Qigong Exercise	18 Years -	McGill University

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