Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Stomach Neoplasms

Esophageal Neoplasms

Stomach Cancer

Esophageal Cancer

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Vitamins

Other Dietary Supplements

Herbal and Botanical

Vitamin D

Cholecalciferol

Curcumin

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Vitamin D3

Calciferol

Whey Protein

Ergocalciferol

Vitamin D2

Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation

Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital

1,000 - 10,000 units daily based on serum levels for the duration of the study

Vitamin D3 Drops

1.5g twice daily for the duration of the study

Coriolus Versicolor

3g once daily for the duration of the study

Trident SAP 66:33 Lemon

12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)

Probiotic Pro12

1 scoop (22g) once daily during the peri-operative period (approximately 1 month pre and post-surgery) and during any adjuvant chemotherapy and radiation treatments

Provitalix Pure Whey Protein

1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation

Theracurmin 2X

700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.

Green Tea Extract

Based on the Mediterranean diet and lower glycemic index foods

Nutrition Recommendations

150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days

Physical Activity Recommendations

Activities with the intention of actively improving the participant's mental and emotional health

Psychological Recommendations

Anna Fazekas, MA, CCRP

Mark Legacy, BSc

Andrew Seely, MD, PhD, FRCSC

Dugald Seely, ND, MSc

Ellen Conte, ND

Tim Asmis, MD, FRCPC

Rebecca Auer, MD, FRCSC, FACS

Kednapa Thavorn, PhD

Dean Fergusson, PhD

Christian Finley, MD, FRCPC

Tim Ramsay, PhD

Salmaan Kanji, BSc, PharmD

Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. Too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings.

The Thoracic POISE project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery.

The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage II

Pioneering Pre- and Post-Operative Integrative Care to Improve Thoracic Cancer Quality of Care - The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial - Stage II

Measured by the number of people who are enrolled in the study compared to the total number screened.

Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.

Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Information on the number of supplements used and the length of use use will be collected at each standard of care visit.

Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Mediterranean diet scores (scale of 0-9) will be calculated in the control group using the Harvard Food Frequency Questionnaire to assess for changes over the 1 year follow up period.

Changes in physical activity will be monitored using the International Physical Activity Questionnaire, which is used to calculate total metabolic equivalent task (MET) minutes.

Measured by the number of participants in the control arm who perform activities in which the goal of the activity was to improve mental and emotional health.

Assessing the type and frequency of communications between research staff at The Ottawa Hospital (TOH) and the Centre for Health Innovation (CHI), as well as within TOH and the CHI through number of emails, phone calls, meetings (in-person or virtual) or any other communication method.

Measured by serum Interferon Gamma Levels

Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews

Measured by serum C-Reactive Protein Levels

Measured by collecting a complete blood count with differential and comparing neutrophil and lymphocyte levels

The Canadian College of Naturopathic Medicine

Lotte & John Hecht Memorial Foundation

The Centre for Health Innovation

University of Ottawa

Ottawa Hospital Research Institute

Nervous System Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

The investigators propose a 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment.

They will be provided with clear and concrete recommendations of activities for the user to perform the rest of the days of the week in order to increase their level of physical activity and increase weekly metabolic expenditure.

There will be 2 weekly sessions of 50 minutes, always guided by a physiotherapist, with the following distribution:

1.- Warm-up: 15 minutes of global exercises of strength and resistance, focusing on the areas that are going to be worked as a priority in that session.

Strength training: 6 to 8 strength exercises of large muscle groups. The approximate duration will be 25 minutes.

3.- Cool down / cool down: Combination of breathing exercises and stretching, 10 minutes.

Monitoring with activity bracelets.

Exercise

They will be provided with a physical activity plan to be followed on a weekly basis.

Physical activity recommendations

Juan Luis Sánchez González, Phd

Carlos Martín Sánchez, Phd

Chemotherapy is a crucial treatment in the fight against colon cancer, but unfortunately, its impact is not limited to cancer cells alone. Chemotherapy drugs, designed to attack fast-growing cells, also affect healthy tissues, leading to various side effects. One of the most common adverse effects is peripheral neuropathy, a condition that affects the peripheral nerves and can manifest as tingling sensations, numbness, pain or weakness in the extremities.

Chemotherapy-induced peripheral neuropathy can be especially challenging for colon cancer patients, as it further aggravates quality of life during an already difficult period. Nerves responsible for motor and sensory function are compromised, affecting the patient's ability to perform daily activities and weakening their physical endurance. This phenomenon adds to the emotional and physical burden of fighting cancer.

However, there are tools that can positively influence these adverse effects, such as physical exercise. Although it may seem contradictory, regular physical exercise has been shown to have beneficial effects on peripheral neuropathy. Physical exercise can improve blood circulation and promote regeneration of damaged peripheral nerves. In addition, exercise helps to alleviate the pain and discomfort associated with neuropathy, thereby strengthening patients' functional capacity.

It is essential to emphasize that any exercise plan must be tailored to the individual capabilities of each patient, and medical supervision is essential. Therefore, the combination of chemotherapy and carefully planned physical exercise offers a comprehensive strategy to address both the disease and its side effects, providing colon cancer patients with a better quality of life during their journey to recovery.

Effects of a Strength Physical Exercise Program in Colorectal Cancer Patients Undergoing Chemotherapy Treatment

Upon request by e-mail to the principal investigator

The EORTC CIPN20 questionnaire will be used.This questionnaire contains 20 items on which patients rate their experience for each symptom during the previous week using scores from 1 (not at all) to 4 (very much). The sum score was obtained by adding the scores of items 1 to 19 resulting in a sum score range of 19 to 76, which was termed CIPN20 sum1-19. Item 20 rates male impotence

It will be evaluated through the the EORTC QLG Core Questionnaire (EORTC QOL-30) quality of life questionnaire in its specific version for colorectal cancer EORT QLQ-CR30. Scores can range from 0 (worst quality of life) to 100 (best quality of life), with higher values indicating better quality of life in the areas evaluated.

Obtained from the participant's weight and height.

It will be evaluated through the 6-minute walk test.

They will be evaluated through the Hospital Anxiety and Depression Scale (HADS). Scores on the HADS can be interpreted as follows:

Anxiety:

0-7: Absence of clinically significant anxiety. 8-10: Possible presence of clinically significant anxiety. 11 or more: Clinically significant anxiety.

Depression:

0-7: Absence of clinically significant depression. 8-10: Possible presence of clinically significant depression. 11 or more: Clinically significant depression.

The Functional Assessment of Cancer Therapy (FACT-F) Questionnaire will be used. FACT-F scores are calculated by summing the scores of the different domains, where higher scores indicate better quality of life. The total score may vary depending on the scale used in the specific questionnaire, but generally ranges from 0 to 176 points.

Will be evaluated through the Minimal Insomnia Symptom Scale (MISS). Each question is scored on a scale of 0 to 4, where 0 indicates that the symptom is not present and 4 indicates a very severe presence of the symptom. Therefore, the total score on the MISS can range from 0 to 12 points.

Interpretations of the MISS scores may be as follows:

0-3 points: Absence or minimal presence of insomnia symptoms. 4-6 points: Mild insomnia symptoms. 7-9 points: Moderate insomnia symptoms. 10-12 points: Severe insomnia symptoms.

It will be registered at the beginning of the study.

It will be registered at the beginning of the study in centimeters.

Juan Luis Sanchez Gonzalez

Principal Investigator. Dr. Juan Luis Sánchez González

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Fatigue

Testicular Neoplasms

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Germ Cells Tumors

Testicular Germ Cell Tumor

At the baseline, all participants will receive the international recommendations in terms of physical activity for promoting health in the general population.

At baseline, all participants will receive a connected activity tracker to wear 24 hours a day during one year. Patients will be asked to download an application, dedicated to the study so that the physical activity data (ie. number of steps per day) will be synchronized in the application.

Connected activity tracker

The intervention will last 1 year and will have 2 phases. Phase 1: At each cycle of chemotherapy, patients will be proposed to perform 2-4 sessions per week. This program will be individual, supervised, performed at a moderate intensity. Between cycles, patients will be asked to perform 1-2 supervised collective live online physical activity sessions per week, proposed by a partner specialized in online PA.

Phase 2: After chemotherapy, patients will be asked to perform 2-3 PA sessions per week at a moderate intensity. Patients will be offered 2 options of PA practice: in the supervised collective live online PA session (as already performed in the phase 1), and/or in a fitness center (this practice will take place in a "classic" environment with a 9-month free access for patients thanks to a partnership).

In addition, patients will benefit from 4 individual motivational interviews, conducted by videoconference and/or by phone call with a professional.

Physical Activity (PA) Intervention

Carmen Dupuis, PhD

Olivia Pérol, MSc

Guillaume MOUILLET, MD

Fabien CALCAGNO, MD

Elsa KALBACHER, MD

Elodie KLAJER, MD

Thierry N'GUYEN, MD

Antoine THIERRY VUILLEMIN, MD

Mathilde CABART, MD

Diego TEYSSONNEAU, MD

Guilhem ROUBAUD, MD

Florence JOLY, Pr, MD

Isabelle BONNET, MD

Emeline MERIAUX, MD

Guillaume CARBONNELLE, MD

Lionnel Goeffrois, MD

Lionnel GOEFFROIS, MD

Albane LHUILLIER, MD

Vincent MASSARD, MD

Camille SIMON, MD

Agnès DUCOULOMBIER, MD

Christophe MASSARD, PhD, MD

Laurence CROUZET, MD

Brigitte LAGUERRE, MD

Aude Fléchon, MD

Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.

Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients

A National, Multicenter, Phase III Randomized Controlled Trial to Assess the Impact of a One-year Supervised Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients

Multidimensional aspects of fatigue will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-FA12 cancer related fatigue module. EORTC QLQ-FA12 consists of 12 items to evaluated physical, cognitive and emotional domains of cancer-related fatigue. Participants will answer to a 4-points Likert scale ranging from "not at all" to "very much". All scores will be transformed to a 0 to 100 scale and higher scores will indicate greater degree of fatigue.

The Primary Outcome Measure will be assessed with physical and cognitive items.

Multidimensional aspects of fatigue will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-FA12 cancer related fatigue module. EORTC QLQ-FA12 consists of 12 items to evaluated physical, cognitive and emotional domains of cancer-related fatigue. Participants will answer to a 4-points Likert scale ranging from "not at all" to "very much". All scores will be transformed to a 0 to 100 scale and higher scores will indicate greater degree of fatigue.

All of the secondary cancer related fatigue dimensions except the physical and cognitive items are evaluated (emotional fatigue, interference with daily life and social sequelae, assessed by the EORTC QLQ-FA12 questionnaire).

Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact).Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden.

The module Quality of Life Questionnaire specific to Testicular Cancer (QLQ-TC26) comprises seven multi-item scales (treatment side effects, treatment satisfaction, future perspective, communication, sexual activity, functioning and enjoyment) and six single items (job and education problems, physical limitations, family problems, infertility, body image problems, testicular transplant satisfaction).Participants will answer to a Likert scale ranging from "not at all" to "very much". All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden.

The cancer-related cognitive impairment will be measured by the Functional Assessment of Cancer Therapy-Cognition (FACT-Cog). The FACT-Cog is a validated self-administrated questionnaire in order to assess memory, attention, concentration, language, and thinking abilities. The questionnaire is composed of 37 items with four subscales: patients' perceived cognitive impairments, perceived cognitive abilities, deficits observed or commented on by others, and impact of cognitive changes on HRQoL. Participant will answer how often this situation occurred during the last 7 days on a Likert-type scale ranging from "never" to "several times a day". For both scales, higher scores indicated better perceived cognitive function.

Hospital Anxiety and Depression scale (HADS) is an instrument used to screen for anxiety and depressive disorders. It has 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing thus obtaining two scores (maximum score for each score = 21).

Weight (in kilograms), Height (in meters), Body Mass Index (in kg/m\^2)

assessed by the 6-minute walk test (distance traveled in meters in 6 minutes)

assessed by the sit-to-stand test (number of repetitions)

PA and sedentary levels will be measured by National Observatory of Physical Activity and Sedentary Lifestyle - Physical Activity questionnaire (ONAPS-PAQ) This questionnaire assesses the level of physical activity and sedentary lifestyle during a typical week for the adult population. It is divided into three parts and 21 questions: activities at work, travel for utilitarian purposes and leisure or home activities. This questionnaire also assesses physical inactivity at all times of life (travel, work, leisure).

assessed by the number of sessions scheduled/performed during the different phases of the intervention

This questionnaire can be used on a daily basis, for all populations, with the aim of better understanding the motivation of individuals to practice physical activities from a health perspective. The challenge is to provide professionals with an appropriate questionnaire that can assess patient motivation at the start and end of PA care.

Participants will answer to a 7-points Likert scale ranging from "does not match at all" to "corresponds very strongly".

This questionnaire assesses several items : intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, amotivation.

The results for each patient should be compared with the results of the validation population.

The association between the pre-intervention PA practice environment (type of activity, practice locations) and compliance with the intervention

Neuropathies assessed by a visual analog scale. Participants will answer to a 0 (better outcome) to 10 (worst outcome) scale.

Pain assessed by a visual analog scale. Participants will answer to a 0 (better outcome) to 10 (worst outcome) scale.

Occurrence of induced-treatment toxicity according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE)

The occurence of second primary malignancy

number of consecutive working days without sick leave

measured using 16s rRNA Illumina sequencing

To validate the psychometric properties of the French version of the EORTC QLQ-TC26 questionnaire assessing the health-related health-related quality of life in patients with testicular cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage II	NCT04871412	Lung Cancer Gastric Cancer Esophageal Canc...	Vitamin D3 Drop... Coriolus Versic... Trident SAP 66:... Probiotic Pro12 Provitalix Pure... Theracurmin 2X Green Tea Extra... Nutrition Recom... Physical Activi... Psychological R...	18 Years -	Ottawa Hospital Research Institute
Effects of a Strength Physical Exercise Program in Colorectal Cancer Patients Undergoing Chemotherapy Treatment	NCT06404359	Oncology Chemotherapy-in...	Exercise Physical activi...	18 Years - 85 Years	University of Salamanca
Effects of a Strength Physical Exercise Program in Colorectal Cancer Patients Undergoing Chemotherapy Treatment	NCT06404359	Oncology Chemotherapy-in...	Exercise Physical activi...	18 Years - 85 Years	University of Salamanca
Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients	NCT05588700	Metastatic Test...	Physical activi... Connected activ... Physical Activi...	18 Years -	Centre Leon Berard

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