Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Fatigue

Quality of Life

500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days.

The objective of this study is to evaluate the efficacy and safety of PG2 as a complementary treatment to conventional chemotherapy among NSCLC patients. In reference to previous studies, "Clinical Benefit Response" and "Incidence of Grade III plus VI Neutropenia" will be used as the primary endpoints in this study. Clinical Benefit Response is a metric measurement including change in cancer or cancer treatment related "fatigue" which is related to chronic fatigue syndrome (CFS), change in karnofsky performance status and change in weight. The secondary endpoints include patient's global quality of life, and the blood c-reactive protein level which is related to weight change, tumor response, survival time, incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the related G-CSF and antibiotics consumption.

This is a multi-center, double-blind, randomized and placebo-controlled study to evaluate complementary effect of PG2 in patients with advanced non-small-cell lung cancer under conventional chemotherapy. Patients with Stage IIIb-IV non-small-cell lung cancer will be screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.

All enrolled patients will be randomized to PG2 or Placebo arm and will receive the cisplatin-based chemotherapy treatment (Cisplatin 75mg/m2 and Docetaxel 60mg/m2 on Day1) during the first three 21-day chemo-cycles. Chemo regimen modification is allowable, as usual, in case of disease progression or unacceptable toxicity (see Section 6). After randomization, each patient will be administered with PG2 or placebo for 4 days in the 1st week, 3 days in the 2nd week and 3 days in the 3rd week of each chemo-cycle for 3 cycles (Dosing Schedule in Section 6). Total 10 doses will be given in each cycle.

Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue

PhytoHealth Corporation

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients in the before group are recruited during the first 4 months of the study and will not benefit from the alternative medicine education consultation

Patients in the front group are recruited from the 5th month of the study and will benefit from the alternative medicine education consultation

The intervention will consist in a 1h30 individual consultation with a GP physician. Patients will be able to ask any questions they have regarding treatments for their breast cancer delivered outside of the hospital. Topics such as benefit-risk ratios, placebo effects and expectancies from CAM will be discussed with the patients. This consultation will promote a shared-decision model to help patients better discuss these matters with their healthcare providers.

alternative medicine education consultation

NICOLAS PINSAULT

MIREILLE MOUSSEAU

PAULINE GIRARD

Shared Decision Making on Care Pathways and alternative and complementary medicine (CAMs) : A Pilot Study.

Study whose aim is to evaluate the feasibility of a study proposing a therapeutic education consultation leaning on the usual care pathway by estimating the recruitment capacity over 4 months as well as the acceptance rate of the study among patients diagnosed with breast cancer.

The use of alternative and complementary medicine (CAMs) has been steadily increasing for several years. Certain populations are more likely than others to use this type of care, including breast cancer patients, for whom the rate of use is close to 90%. However, these populations are those for whom the risks associated with this type of care are the highest. In addition, patients rarely discuss alternative and complementary medicine (CAMs) with conventional care teams. As a result, patients often place unreasonable expectations on alternative and complementary medicine (CAMs) and at the same time put themselves in risky situations.

The aim of this project is to help breast cancer patients better orient themselves in their care pathway and in particular with regard to the plethora of alternative and complementary medicine (CAMs) available. They could therefore make an informed decision to seek (or not) treatment. In order to reach a shared decision, a consultation will be offered to patients with the objective of discussing their past recourse, their knowledge of the care pathway, their fears and their aspirations with regard to alternative and complementary medicine (CAM). Epistemological concepts (self-efficacy, placebo, benefit-risk ratio, etc.) will be discussed in order to allow these elements to be transposed throughout their care.

The impact of this consultation on compliance with conventional treatment, satisfaction with the treatment as a whole and communication with the rest of the health care team will be evaluated. A before/after methodology will first allow us to evaluate the values taken by our judgement criteria in the usual care pathway and then in the innovative care pathway proposed by the intervention. This study will allow us to establish the feasibility of a future research project of larger scale.

Quasi-experimental, before-and-after, comparative, prospective, single-center, open-label study.

Shared Decision Making on Care Pathways and CAMs: A Pilot Study

The investigators wish know the recruitment capacity in this study. To do this, the investigators will estimate the number of people included over 8 months (time of recruitment in the study).

"Health Literacy Questionnaire" (HLQ) at 6 month post intervention. Questionnaire contains 2 parts : P1 with 23 questions, and P2 with 21 questions.

Coding:

P1Q1 to P1Q23

* Strongly Disagree = 1
* Disagree = 2
* Agree = 3
* Strongly Agree = 4

P2Q1 to P2Q21

* Cannot do or always difficult, = 1
* Usually difficult = 2
* Sometimes difficult = 3
* Usually easy = 4
* Always easy = 5

The HLQ consists of 9 scales representing 9 dimensions of health literacy. Each HLQ scale has 4-6 items. The HLQ does not provide one overall summative score. The scoring of the HLQ is 9 scale scores, calculated by averaging the item scores within each scale with equal weighting. The 9 scale scores will reflect a person's strengths and needs in the different dimensions of health literacy.

For Scales 1 to 5, the score range is between 1 and 4 For Scales 6 to 9, the score range is between 1 and 5

To assess the HQL (Health Literacy Questionnaire) Minimal Clinically Interesting Difference at 6 months after the intervention.

The investigators wish to assess the Minimal Clinically Interesting Difference at 6 months after the intervention by comparing the response about the satisfaction with improvement in orientation to the care pathway (0: No improvement, 1 : Slight improvement, 2 : Good improvement, 3 : Excellent improvement) " to the HLQ dimensions of interest.

The investigators wish to assess PALS by comparing the response to the question "Do you feel able to learn about services and supports to ensure that all your health needs are met? ( YES/NO)" to the HLQ dimensions of interest.

PALS will be binary, either patients feel able to orient themselves in the care pathway or they do not feel able to do so

Bilateral 6-item Likert scale at 6 months after surgery (-3: very dissatisfied to +3 very satisfied )

Semi-directive interview conducted at 6 months after the intervention. This interview will be carried out only for some patients of the study until data saturation.

CHBQ questionnaire completed at inclusion (pre-intervention) and at 6 months (post-intervention by the patient.

This questionnaire is composed of 10 propositions. The total score varies between 10 (total disagreement with all the proposals) and 70 (total agreement with all the proposals). The authors suggest that above the median score of 40, the respondent has a positive attitude towards TACs and conversely a negative attitude towards TACs for a score below 40.

CHBQ questionnaire completed by the oncologist at the beginning of the study (before the start of the inclusion).

This questionnaire is composed of 10 propositions. The total score varies between 10 (total disagreement with all the proposals) and 70 (total agreement with all the proposals). The authors suggest that above the median score of 40, the respondent has a positive attitude towards TACs and conversely a negative attitude towards TACs for a score below 40.

If individuals have used TACs, then they are offered a simplified and adapted version of the CAMP-Q (Complementary and Alternative Medicine Practitioner Use Questionnaire) completed at inclusion and 6 months after the intervention by the patient.

This questionnaire includes 49 questions and the objective will be to evaluate if the patient has used one or more alternative medicines (1) or no alternative medicine (0). It don't have a rating

Bilateral 6-item Likert scale (-3: very dissatisfied to +3 very satisfied) at baseline and 6 months after the procedure ONLY if at least one complementary alternative technique was checked in answer n°1 of the CAMP Q questionnaire.

This is to have a before and after evaluation.

Two-sided 6-item Likert scale (-3: very dissatisfied to +3 very satisfied ) at 6 months post intervention. These goals are only evaluated for patients in the AFTER group

Two-way 6-item Likert scale (-3: very dissatisfied to +3 very satisfied ) evaluated after the intervention and at 6 months. This objective is only evaluated for patients in the AFTER group

Two-way Likert scale with 4 items (-2 not at all agree to +2 completely agree ) evaluated after the intervention and at 6 months. This objective is only evaluated for patients in the AFTER group

University Grenoble Alps

Laboratoire TIMC-IMAG

University Hospital, Grenoble

Participants will be given the CAM intervention during scheduled, standard of care radiotherapy (up to 6 weeks) and 8-12 weeks (weeks 14-18) after radiotherapy.

CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.

Complementary and alternative medicine (CAM)

Jennifer J Hu, PhD

The purpose of this research is to study a Chinese herbal Complementary and Alternative Medicine (CAM) product for the temporary relief of pain and itching after radiotherapy (RT). This is an over-the-counter product with 1% menthol as an active ingredient.

Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences

Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician.

Skindex 16 (SD-16) will be used to assess patients' self-assessment of skin effects. SD-16 has a total score ranging from 0-96 with a higher score indicating greater skin effects.

FACT-B in breast cancer patients will be used to obtain patient's self-assessment of health-related quality of life. FACT-B has a total score ranging from 0-148 with a higher score indicating a better quality of life.

The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples.

VAUGHN-JORDAN FOUNDATION, INC.

Florida Breast Cancer Foundation

University of Miami

Professor

Recurrence

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Disease Attributes

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Melatonin

Antioxidants

Protective Agents

To receive 20 mg of melatonin nightly for 1 year post-surgery

To receive 20 mg placebo nightly for 1 year post-surgery

melatonin

similar to experimental in all ways except for lack of active ingredient

placebo

Dugald MR Seely, ND, MSc

Andrew JE Seely, MD

There is evidence to support the use of melatonin, a natural health product, as an additional treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20 milligrams of melatonin for one year can lower the incidence of developing lung cancer recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are eligible for surgical resection can participate in the trial. The study will also be assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression amongst the participants.

The trial employs a two-armed parallel placebo controlled trial design whereby patients with a diagnosis of non small cell lung cancer are randomized to receive either 20 mg of melatonin nightly or an identically matched placebo. All patients will be followed for two years with primary outcomes assessed at a two year time point and secondary outcomes evaluated throughout the course of the trial.

Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality

Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial

Disease-Free survival (DFS) at 2 years post-surgery. DFS is measured by the number of participants in both arms who have experienced a recurrence OR mortality at 2 years.

Participant-reported quality of life using the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C-30 (EORTC QLQ C-30) and Lung Cancer 13 (EORTC QLQ LC13) questionnaires. Scores represent a value from 0-100. Symptom and LC13 scale: 0 represents best health, 100 worst health. Global and functional scales: 100 represents best health, 0 represents worst health. Full scoring algorithms available here: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf

Measured using the Multidimensional Fatigue Inventory 20 (MFI-20) questionnaire. Scores are on a scale of 0-100, where 100 is the best health and 0 is the worst health.

Measured using the Medical Outcomes Study (MOS) Sleep Survey. Scales used were Sleep Adequacy and Sleep problems Index II. Scores are on a scale of 0-100. Sleep Adequacy: 100 represents best health; 0 represents worst health. Problems index: 0 represents best health; 100 represents worst health.

Calculated using the Brief Pain Inventory. Each scale ranges from 0-10, where 0 is no pain and 10 is the worst possible pain.

Measured using the Beck Anxiety Inventory. Scored range from 0-63, where 0 is no anxiety and 63 is the worst possible anxiety.

Measured using the Beck Depression Inventory II. Scores range from 0-63, where 0 is no depression and 63 is the worst possible depression.

Number of participants who experienced an adverse event related to their adjuvant chemotherapy

Measured as disease-free survival (DFS) at 5 years. DFS was measured by the incidence of a recurrence OR mortality up to 5 years post-surgery.

NK cell cytotoxicity changes from baseline to 6 months

Number of participants who experienced an adverse event related to their adjuvant radiation therapy

Differences in NK cell cytotoxicity between both arms

The Ottawa Hospital

Lotte & John Hecht Memorial Foundation

Gateway for Cancer Research

The Canadian College of Naturopathic Medicine

An adverse event is any untoward medical occurrence in a patient administered a medicinal product which does not necessarily have to have a causal relationship with this treatment. A serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or results in prolonging of existing hospitalization, results in a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

To receive 20 mg placebo nightly for 1 year post-surgery

placebo: similar to experimental in all ways except for lack of active ingredient

Placebo

To receive 20 mg of melatonin nightly for 1 year

melatonin: 20 mgs ingested nightly

Treatment

To receive matched supplement to the experimental arm in same schedule

placebo: similar to experimental in all ways except for lack of active ingredient

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Pre-Operative Chemotherapy or Radiation

Current Smoker

Past Smoker

Never Smoked

Unknown

Smoking History

Squamous Cell

Adenocarcinoma

Large Cell

Bronchoalveolar

Undifferentiated

Other

Non-Surgical

Histological Subtype

Minimally Invasive Surgery (MIS)

MIS Converted to Open

Open

Incision Type

Pneumonectomy

Lobectomy

Segmentectomy

Wedge Resection

No Operation

Surgery Type

Stage I

Stage II

Stage III

Stage IV

Overall 7th Edition American Joint Committee on Cancer (AJCC) stage (I-IV) based on the TNM classification. T refers to tumor size, N refers to nearby lymph nodes and M represents metastasized (spread) to other parts of the body. This staging number is obtained as a sum of the TNM classification. The lower the number, the lower the cancer stage and the better the prognosis for the patient. The higher the stage, the worse the prognosis.

Pathological Cancer Stage

Mark Legacy, Clinical Trial Coordinator

Analysis conducted was an adjusted logistic regression (adjuvant chemotherapy, adjuvant radiation, smoking history). Results were presented as a relative risk. Based on an estimated 30% outcome rate of recurrence or mortality in the control arm, 294 participants per arm provided 80% power to detect a relative risk of one third at an alpha of 0.05. We inflated this sample size to 346 per arm to account for 15% lost to follow-up.

To receive 20 mg of melatonin nightly for 1 year following surgery.

To receive 20 mg placebo nightly for 1 year following surgery

placebo: similar to experimental in all ways except for lack of active ingredient

Intention to treat - all participants analyzed.

Lung Cancer Recurrence or Mortality - 2 Years

Symptom Scale (Baseline)

Symptom Scale (1Y)

Symptom Scale (2Y)

Functional Scale (Baseline)

Functional Scale (1Y)

Functional Scale (2Y)

Global Scale (Baseline)

Global Scale (1Y)

Global Scale (2Y)

LC13 Scale (Baseline)

LC13 Scale (1Y)

LC13 Scale (2Y)

To receive 20 mg of melatonin nightly for 1 year post surgery

To receive 20 mg placebo nightly for 1 year post surgery

placebo: similar to experimental in all ways except for lack of active ingredient

Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.

Baseline

Sleep Adequacy (Baseline)

Sleep Adequacy (1Y)

Sleep Adequacy (2Y)

Sleep Problems Index II (baseline)

Sleep Problems Index II (1Y)

Sleep Problems Index II (2Y)

Sleep

3 months

Only those recruited from the Ottawa Hospital were included in this analysis.

Pain Levels

Only participants recruited from The Ottawa Hospital were included in the analysis.

Anxiety

Depression

Only those who received adjuvant chemotherapy were included in this analysis.

Adverse Events (Chemotherapy)

DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.

This analysis included only those with stage I or II cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.

This analysis included only those participants who had stage III or IV cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.

All participants

Early Stage Cancer

Late Stage Cancer

To receive 20 mg of melatonin nightly for 1 year following surgery

Lung Cancer Recurrence or Mortality - 5 Years

Cytotoxicity (baseline)

Cytotoxicity (6 months)

Participants who qualified for the sub-study only.

Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values)

Only those who received adjuvant radiation were included in this analysis.

Adverse Events (Radiation)

This analysis compares the mean ratios of 6 month cytotoxicity and baseline cytotoxicity between arms.

Only those who were enrolled in the sub study and qualified for analysis were included.

Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups)

To receive 20 mg of melatonin nightly for 1 year

melatonin: 20 mg ingested nightly

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue	NCT00518869	Quality of Life Fatigue Complementary	PG2	17 Years - 75 Years	PhytoHealth Corporation
Shared Decision Making on Care Pathways and CAMs: A Pilot Study	NCT05388734	Breast Cancer Non-metastatic Newly Diagnosed Feasibility Stu...	alternative med...	18 Years -	University Hospital, Grenoble
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences	NCT04650256	Skin Toxicity	Complementary a...	18 Years -	University of Miami
Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality	NCT00668707	Non Small Cell ...	melatonin placebo	18 Years -	The Canadian College of Naturopathic Medicine

Spots Global Cancer Trial Database for complementary and alternative medicine (cam)