Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Participants of the intervention group (n=20) will receive 1 capsule of Methylphenidate HCl 10 mg SR each morning during 14 days during phase 1 and 2 capsules of Methylphenidate HCl 10 mg SR each morning during 14 days during phase 2.

Participants of the control group (n=20) will receive 1 capsule of placebo each morning during 14 days during phase 1 and 2 capsules of placebo each morning during 14 days during phase 2.

Methylphenidate HCl 10Mg SR (Phase 1) and Methylphenidate HCl 20Mg SR (Phase 2)

Methylphenidate HCl 10Mg SR

Placebo Group

Bruno Gagnon

Cancer-related cognitive Impairment (CRCI), commonly referred to as "chemo brain" or "brain fog"-impact severely on the Quality of Life (QoL) of cancer survivors. However, it still remains underdiagnosed and challenging to treat. One of the treatment options is the use of psychostimulants such as Methylphenidate (MP), but well-designed clinical trials to test its efficacy are limited. We will conduct a phase II study with a mixed method design to explore the preliminary efficacy of MP to improve cognitive function and QoL in breast cancer patients after treatment with chemotherapy and/or radiotherapy and determine the parameters needed for designing a phase III study.

Objectives: The main objective of this study is to determine the parameters for a phase III study to measure the efficacy of MP in improving CRCI in women with breast cancer who received chemotherapy and/or radiotherapy. In addition, the profile of drug side effects will be estimated. A better understanding of CRCI and its impact on the activities and QoL of the study population is targeted.

Population: The sample will consist of 40 women in remission of non-metastatic breast cancer whose profile meets the following criteria:

1. receiving follow-up at the radio-oncology department of the CHU de Québec-Université Laval or at any other health institutions in Quebec participating in the project;
2. complaining about cognitive impairment;
3. not having any contraindications to the taking of MP or any medical condition that may interfere with his taking and/or any medical condition that could explain the cognitive impairment.

Before study inclusion, the eligibility of these women will be validated by questionnaires and medical records.

Study design: This study will follow the design of a randomized, double-blind, placebo-controlled trial that includes a mixed methodology (convergent design).

Procedures: The study will be divided into two phases. The first phase will start at time T0, before any MP is taken, and will last 14 days (T1). Participants will be assigned to the intervention group, where they will receive 10 mg of MP controlled-release (SR) for 14 days, or the control group where they will receive an identical placebo capsule for 14 days. The second phase begins at T1 and ends 14 days later (T2). This phase will explore a higher dosage. Participants from the intervention group during phase 1 will received an increased dose of MP (20 mg - two capsules) during 14 days whereas participants from the control group will receive two placebo capsules during 14 days.

Measures: Quantitative data. Questionnaires and tests will be used. The effect size calculation will be based on the 'Perceived Cognitive Impairments' (PCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function questionnaire (FACT-Cog) test and will be used to determine the required power for a phase III study. Other tests will be explored to assess the sensitivity to measure cognitive changes. Descriptive statistical analysis will be performed. Tests such as the T-Test, χ2 and ANOVA will be used to estimate the degree of improvement of cognitive function by comparing data of the different groups. Qualitative data. Interviews will be conducted with the 40 women included in the study. These interviews will focus on their experience of cognitive deficits before and after taking MP/Placebo at T0 and T2. In order to document the experience of these women and to assess the transferability of the resutls, two methods will be combined to analyze these interviews: an intra-case analysis and an inter-case analysis. Each of the components of the study will answer its main questions independently. However, the data will also be matched (triangulation) to provide a global understanding of the issue and convergence of results when possible.

Effect of Methylphenidate on Cancer-related Cognitive Impairment

Étude Pilote de Phase II Sur l'Effet du méthylphénidate Sur la Fonction Cognitive Des Patientes en rémission d'un Cancer du Sein

'Perceived Cognitive Impairments' (PCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function questionnaire (FACT-Cog) test

Tracking and registration of methylphenidate side effects

Fatigue evaluation with a validated questionnaire: Multidimensional Fatigue Inventory (MFI)

Équipe de Recherche Michel-Sarrazin en Oncologie psychosociale et Soins palliatifs

Purdue Pharma LP

Fondation de l'Hôtel-Dieu de Lévis

CHU de Quebec-Universite Laval

Associate Professor

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml

This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml

The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.

Short Chain Fructooligosaccharides

This group will receive 12 g of corn starch as a control group.

Carolina Martinez Loya

Ruth Favela Ortiz

Carolina Martínez Loya, M.D.

Ruth S Favela Ortiz

Luis B Enríquez-Sánchez

The purpose of this study is to determine if there is a difference in the clinical characteristics of patients with polycystic ovary syndrome after the administration of SC-FOS in the enteral diet compared to patients with a standard diet.

The protocol will be discussed with the patients and/or relatives of the patients, who will understand the consequences and advantages of the study and will thus sign the consent.

Once informed consent has been obtained, the group to which each patient belongs will be randomly assigned.

Patients will be selected according to the inclusion and exclusion criteria of the population diagnosed with PCOS with useful enteral route for random assignment into two groups, one will be administered short-chain Fructooligosaccharides at a dose of 12 g every 24 hours, another group will be given saline as a placebo to the enteral diet every 24 hours for 10 days. Patients should take the solution on an empty stomach.

Once the type of intervention has been determined, the patient will be given the suspensions corresponding to group 1 or placebo, with vials in which the content cannot be visualized, numbered according to the sheet obtained by the corresponding randomization. The initial evaluation will be completed with all the clinical characteristics to be evaluated.

The patient will be told that every 24 hours he must take 1 suspension on an empty stomach, which will be prepared at a rate of 12 grams of SC-FOS in 15 cc of saline solution for the prebiotic preparation vs 15 cc of saline solution for the placebo group. The solution will be administered enterally for 10 consecutive days at a single dose per day, and a reassessment will be made on the seventh day of the clinical characteristics of the patients, to compare and evaluate the results.

Prospective study, randomized single blind clinical trial

To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome

To Study the Clinical Effect of SC-FOS Prebiotics in Enteral Diet vs. Standard Enteral Diet on Clinical Characteristics of Patients With Polycystic Ovary Syndrome According to the Rotterdam Classification in Chihuahua, Chihuahua. A Randomized Single-Blind Clinical Trial

The data obtained from this research study will be available if requested once the study is finalized.

Score obtained by Stool Consistency Bristol Scale:

This scale consist in seven types of stool:

Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)

Short Form Health Survey (SF-36) is a measure of health-related quality-of-life:

It comprises 36 questions that cover eight domains of health

1. Limitations in physical activities because of health problems.
2. Limitations in social activities because of physical or emotional problems
3. Limitations in usual role activities because of physical health problems
4. Bodily pain
5. General mental health (psychological distress and well-being)
6. Limitations in usual role activities because of emotional problems
7. Vitality (energy and fatigue)
8. General health perceptions

Universidad Autonoma de Chihuahua

Medical Doctor

Nausea

Vomiting

Signs and Symptoms, Digestive

Placebo Group: In this group the participants received TENS with frequency of 75Hz, pulse duration of 200 microseconds. The stimulation time will be for only 10s.

Low Frequency Group: In this group the TENS will be adjusted with frequency of 10Hz, pulse duration of 200 microseconds. The stimulation time will be 30 minutes and the intensity will be constantly adjusted in order to keep as high as possible within the tolerance threshold of the patient.

High Frequency Group: In this group the TENS will be adjusted with frequency of 150Hz, pulse duration of 200 microseconds. The stimulation time will be 30 minutes and the intensity will be constantly adjusted in order to keep as high as possible within the tolerance threshold of the patient.

In this group, the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the opposite arm of the chemotherapy infusion, but in this group the electrical stimulation will be performed just by 10 seconds and turn off for all reminiscent time of the protocol.

In this group the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the arm opposite the chemotherapy infusion. The electrical stimulation will be continued for all time secession. The electrical pulse parameters will be setting according describe early.

Low Frequency Group

High Frequency Group

Fabrício Macagnan, PhD

Elizete Keitel, Dr

Chemotherapy induces nausea and vomit for some large patients. But, some chemotherapy protocol has a high indices of the incidence as observed in a combination of Anthracycline and Cyclophosphamide (AC). To prevent this symptoms, some medication can be used as Ondansetron. By other hands, the traditional acupuncture on Chinese Medicine have been used a PC6 point to avoid nausea and vomit. More recently, a transcutaneous electric nerve stimulation (TENS) also has been used for this application. Our study will test the TENS applied on PC6 point with two different frequencies (high and low) to evaluated the nausea and vomit inhibition effects.

We will enroll 84 women that being starts a chemotherapy protocol with a Anthracycline and Cyclophosphamide (AC) as a part of breast cancer treatment. All volunteers will be submitted a 30 minutes TENS prior to chemotherapy administration. Three different TENS treatment will be test: 1) placebo; 2) high frequency and 3) low frequency. The self-adhesive electrodes will be positioned in the same position for all different TENS treatment (opposite arm to the chemotherapy infusion). The eletctrodes will be positioned as follows: the first electrode at the PC6 point which is located proximal to the flexion fold of the wrist in the middle of the anterior face of the forearm, between the tendons of the long palmar and radial flexor muscles of the carpus and the second electrode at any point in the hand. After that, all volunteers will receipt a formulary to self-complete a nausea and vomit symptoms record during the next 24 hours. Number of incidence and magnitude of the symptoms will express the accumulated indices the occurrence and severity of the symptoms, as further describe in this protocol.

The selection of the investigated will be characterized as non-probabilistic with a convenience approach, whose patients will be included in the study sequentially until the necessary sizing has been achieved. Patients will be included sequentially for convenience (according to the inclusion and exclusion criteria) and non-probabilistic. The included individuals will be randomly randomized by Random Allocation System software in three groups, 1) placebo group; 2) High Frequency Group; 3) Low Frequency Group.

The participant will be blind to the TENS allocation.

Women with indication for neoadjuvant or adjuvant chemotherapy treatment with the combination of anthracycline and cyclophosphamide associated with Ondasetron

Electric Stimulation on Nausea and Vomit Chemotherapy Induced

Transcutaneous Electric Nerve Stimulation Effects on Nausea and Vomit Chemotherapy-induced

The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy.Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.

As for the intensity of nausea, a Visual Analog Scale will be used to help measure the intensity of each patient. The instrument will question the patient about the degree of nausea and it will provide an auto report with a note that can vary from 0 to 10, with note 0 representing absence of the symptom while note 10 represents the most intense sensation experienced by the patient . Participants will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the investigators when they return to the outpatient clinic for another round of chemotherapy.

The severity assessment of vomiting episodes includes a diary to record the number of episodes of vomiting, which may be small, medium or large. Thus, we will assess the severity of vomiting over 24 hours after the infusion of the first cycle of high grade emetic chemotherapy. Participants will be instructed to complete the instrument and take the questionnaire home, bringing it back to the investigators. When they return to the clinic for another round of chemotherapy.

The 24-hour follow-up record of symptoms of nausea and vomiting will be performed using a form developed from the MASEM anti-emetic instrument (MAT), especially for the present study. This form includes a diary to record emetic events within 24 hours after the administration of chemotherapy. Thus, we will evaluate: the cumulative index of nausea and vomiting over 24 hours after the infusion of the first cycle of emetic high-grade chemotherapy, the volume of vomiting in each episode and the need for rescue antiemetics will also be recorded. Will be instructed to fill out the instrument and take the questionnaire home, bringing it back to the researchers when they return to the clinic for their second course of chemotherapy.

At home and at the end of 24 hours, will be asked to fill in the Edmonton Symptom Assessment Scale where symptoms of pain, tiredness, drowsiness, appetite, nausea, shortness of breath, depression, anxiety and well-being will be evaluated, Based on the Brazilian Consensus on Nausea and Vomiting. It is a scale where the patient provides an auto-report with a note that can vary from 0 to 10, with note 0 representing absence of the symptom while note 10 represents the most intense sensation experienced by the patient.

Irmandade Santa Casa de Misericórdia de Porto Alegre

Federal University of Health Science of Porto Alegre

Heart and Blood Diseases

Rare Diseases

Neoplasm Metastasis

Sclerosis

Scleroderma, Systemic

Scleroderma, Diffuse

Raynaud Disease

Neoplastic Processes

Connective Tissue Diseases

Skin Diseases

Vascular Diseases

Livedoid Vasculopathy

Thrombosis

Embolism

Embolism and Thrombosis

Peripheral Arterial Disease

Peripheral Vascular Diseases

Skin Diseases, Vascular

Systemic Scleroderma

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Analgesics

Pharmaceutical Solutions

Lidocaine

Botulinum Toxins

Botulinum Toxins, Type A

abobotulinumtoxinA

Nitrous Oxide

Prilocaine

* BOTOX® solution
* Saline serum
* lidocaine/prilocaine cream
* Nitrous oxide/oxygen (50%/50%)

Intervention Description :

* BOTOX 100 UNITES (Allergan, Courbevoie, France, and São Paulo, Brazil) Single injection schedule of BOTOX® in both hands, diluted in 2 ml of sterile serum saline, with a dosage of 50 UI (1 ml) by hand. Injections will be performed at the level of the distal palmar crease, targeting the neurovascular bundles in the 4 web spaces (0.25 ml/injection site)
* between 2 to 3 hours before the procedure, application of lidocaine/prilocaine cream under an occlusive dressing (polyurethane film) in each palmar crease of the patients (1/2 tube/hand), according to the recommendations of the manufacturer
* inhaled nitrous oxide/oxygen (50% / 50%) may be used, if needed

* Saline serum
* lidocaine/prilocaine cream
* Nitrous oxide/oxygen (50%/50%)

Intervention Description :

* Sterile saline solution Single injection schedule of 2 ml (1 ml by hand) of serum saline, in both hands. Injections will be performed at the level of the distal palmar crease, targeting the neurovascular bundles in the 4 web spaces (0.25 ml/injection site).
* between 2 to 3 hours before the procedure, application of lidocaine/prilocaine cream under an occlusive dressing (polyurethane film) in each palmar crease of the patients (1/2 tube/hand), according to the recommendations of the manufacturer of the lidocaine cream.
* inhaled nitrous oxide/oxygen (50% / 50%) may be used, if needed

Botox solution + Saline serum + lidocaine/prilocaine cream + Nitrous oxide/oxygen (50%/50%)

BOTOX® solution

Placebo + lidocaine/prilocaine cream + Nitrous oxide/oxygen (50%/50%)

Placebo group

Patricia Senet, MD

This study aims to assess whether or not a single injection schedule of botulinum toxin A (BTX-A) in both hands improves Raynaud phenomenon (RP) secondary to systemic sclerosis (SSc) better than a placebo at 4, 12 and 24 weeks after the treatment.

This study's hypothesis is that the number of RP attacks per week from baseline to 4 weeks after treatment is significantly lower in the group treated with BTX-A than in the control group treated by the placebo. Furthermore, BTX-A in both hands is expected to improve both symptomatic (attack frequency, digital ulcer healing) and functional (pain, hand function, quality of life) symptoms of RP secondary to SSc more than placebo.

In SSc, RP is present in 95% of the patients. Despite cold avoidance, RP attacks are severe, painful, affecting the quality of life, with frequent severe ischemic symptoms such as digital ulcers. Treating patients with RP secondary to SSc is extremely challenging. Oral calcium channel blockers, the most commonly prescribed drugs, were shown to be minimally effective in reducing frequency and severity of RP attacks. There is limited evidence for the efficacy of alpha-1-adrenergic receptor antagonists, angiotensin receptor blockers, phosphodiesterase inhibitors and endothelin-1 receptor antagonists to treat RP. The intravenously administered prostacyclin analogue iloprost is considered a second-line therapy, after oral calcium channel blockers, but its administration requires a 5-days hospitalisation for progressive increase in dosage and close blood pressure monitoring. Side effects are almost constant: headache, flushing, malaise and hypotension. Between 2004 and 2015, a total of 145 patients underwent botulinum toxin-A (BTX-A) injections to treat RP in case reports, retrospective or open studies. Since 2016, only 1 randomized, controlled study was performed, including 40 patients but was underpowered, not designed for clinical outcomes, and treated the patient only in one hand. Symptomatic patients treated by BTX-A experienced, in the 3 to 6 following months, pain relief in 75-100% of the cases, as well as reduction in severity and frequency of attacks and increased ulcer healing rate, with minimal adverse effects. The most common complication was temporary hand weakness, related to the injected dose. When the total dose/hand was 50 UI or lower, the rate of hand weakness was 0 to 9%. The proposed study is the first randomized double blinded multicenter clinical trial designed to assess whether or not a single injection schedule of BTX-A in both hands improves RP secondary to SSc better than a placebo at 4, 12 and 24 weeks after the treatment.

Multicenter, double-blind, randomized, placebo-controlled, parallel groups, phase III

this study is double blind masking: Both participants and investigators are unaware of the intervention assignment, others including statistician

Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis

Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Study to Assess Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis

Comparison between the 2 groups of the change (absolute) from baseline in the number of RP attacks per week at 4 weeks. An attack is defined as an episode of pallor or cyanosis (with or without pain, tingling or numbness). Subjects will keep a daily record of the number of RP attacks they experienced per day and the duration of each attack, from Day -14 to Day 0 (+/- 4 days) and from Day 14 to Day 28 ( +/- 4 days)

Comparison between the 2 groups of the change (absolute) from baseline in the number of RP attacks per week at 12 and 24 weeks. Subjects kept a daily record of the number of RP attacks they experienced per day and the duration of each attack, over a 14-day +/- 4 days period before each assessment visit at 12 and 24 weeks

Comparison between the 2 groups at 4, 12 and 24 weeks of follow-up after the treatment of the percentage of digital ulcers with complete healing

Comparison between the 2 groups at 4, 12 and 24 weeks of follow-up after the treatment of the number of new digital ulcers.

Comparison between the 2 groups at 4, 12 and 24 weeks of follow-up after the treatment of the change in Raynaud's pain score. Pain associated with each attack is self-reported on a 10-point scale, and averaged over 14-day +/- 4 days period before each assessment visit

Comparison at 4, 12 and 24 weeks of follow-up after the treatment of the change in Raynaud's Condition Score. Raynaud Condition Score is a daily self-assessment of RP activity using a 0-10 ordinal scale and averaged over 14-day +/- 4 days period before each assessment visit. The RCS incorporates the cumulative daily frequency, duration, severity and impact of RP attacks.

Comparison between the 2 groups at 4, 12 and 24 weeks of follow-up after the treatment of the change in quality of life from baseline to weeks 4, 12 and 24. QOL is assessed by the Health Assessment Questionnaire (HAQ)

Comparison between the 2 groups from baseline to 4, 12 and 24 weeks of follow-up after the treatment of the change in hand function measured by Quick-DASH (Disabilities of the Arm, Shoulder and Hand)

Comparison between the 2 groups from baseline to at 4, 12 and 24 weeks of follow-up after the treatment of the change in hand function measured by the Hand Function Scale of Cochin

Frequency and severity of adverse drug events during treatment from baseline to weeks 4, 12 and 24.

Assistance Publique - Hôpitaux de Paris

Prostatic Neoplasms

Recurrence

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Disease Attributes

Quality of Life

Other Dietary Supplements

Herbal and Botanical

Androgens

Omega 3 Fatty Acid

Sunflower

5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.

5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.

5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months

MAG-EPA

5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months

Vincent Fradet, MD, PhD

Carole Plante, Inf

Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about the benefits, physicians and patients are seeking alternatives to delay androgen deprivation therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical experimental studies and randomized clinical trials of intermediate prostate cancer outcomes. The current observational evidence also supports testing LCn3 in prostate cancer patients. LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other outcomes, contrasting sharply with ADT-associated side effects.

Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily, including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or prostate cancer progression after a curative treatment.

This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial.

Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

Étude Pilote randomisée de Phase IIB, contrôlée Par placébo, évaluant l'Effet thérapeutique d'Une supplémentation en Omega-3 (Principalement EPA) Chez Des Patients en récidive Biochimique ou en Progression du Cancer de la Prostate.

Efficacy of a one-year MAG-EPA supplementation versus placebo on PSA kinetics will be evaluated based on the comparison of PSA doubling time from baseline to 12 months. The investigators will measure PSA level every three months and calculate PSA doubling time at 12 months (using a linear regression approach) after randomisation using the randomisation PSA value as the starting point. PSA slope will be defined as the linear regression line of the natural log of PSA (in ng/mL) against time (in months). PSA doubling time will be defined as the natural log of 2 divided by the PSA slope.

The changes of fatty acid levels in red blood cell membranes, relative to their baseline levels, will be measured every three months. The profile of fatty acids will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids.

Digestive System Diseases

Blood and Lymph Conditions

Stomach Neoplasms

Fatigue

Anemia

Pancreatic Neoplasms

Stomach Cancer

Pancreatic Cancer

Anti-Inflammatory Agents

Antirheumatic Agents

Hematinics

Chrysarobin

Epoetin Alfa

Patients enrolled in the study will be randomized to receive either 40,000 units of epoetin alfa on day 1 and day 8. Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.

Patients enrolled in the study will be randomized to receive either 40,000 units of placebo (saline) on day 1 and day 8. Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.

Epoetin Alfa group

Stephen R. Grobmyer, MD

This pilot study is looking at how well epoetin alfa, given in the immediate post-operative period, works in reducing anemia and the need for transfusions.

This is a pilot, single center, prospective, double blinded, randomized study comparing epoetin alfa versus placebo. Eligible patients will just have undergone a major abdominal operation for malignancy (esophagectomy, gastrectomy, partial hepatectomy, partial pancreatectomy, or low anterior resection of rectum) and have a post-operative hemoglobin greater than 8 g/dL and less than 11 g/dL on post-operative day #1. On post-operative day #1 patients enrolled in the study will be randomized to receive either 40,000 units of epoetin alfa or placebo. On post-operative day #8, the patients will receive an additional dose of epoetin alfa or placebo (depending on randomization assignment and Hgb level). Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.

Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer

Placebo-Controlled Pilot Study to Assess the Post-Operative Administration of Epoetin Alfa on Patients Undergoing Abdominal or Pelvic Surgery for Malignancy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Methylphenidate on Cancer-related Cognitive Impairment	NCT02970500	Breast Cancer F... Cancer-Related ...	Methylphenidate... Placebo Group	18 Years - 75 Years	CHU de Quebec-Universite Laval
To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome	NCT05999097	Polycystic Ovar...	Short Chain Fru... Placebo Group	18 Years - 65 Years	Universidad Autonoma de Chihuahua
Electric Stimulation on Nausea and Vomit Chemotherapy Induced	NCT03145727	Breast Cancer F... Acupuncture	Placebo Group Low Frequency G... High Frequency ...	18 Years - 65 Years	Federal University of Health Science of Porto Alegre
Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis	NCT03717961	Raynaud Phenome...	BOTOX® solution Placebo group	18 Years -	Assistance Publique - Hôpitaux de Paris
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.	NCT03753334	Prostate Cancer	MAG-EPA Placebo group	18 Years - 100 Years	CHU de Quebec-Universite Laval
Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer	NCT00294203	Anemia	Epoetin Alfa gr... Placebo group	18 Years -	University of Florida
The Efficacy and Safety of Caffeic Acid for Esophageal Cancer	NCT03070262	Esophagus Cance...	CA placebo group	18 Years -	The First Affiliated Hospital of Henan University of Science and Technology
Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer	NCT00294203	Anemia	Epoetin Alfa gr... Placebo group	18 Years -	University of Florida
Synergic Effects of Physical Activity and Probiotic on Gut Immune System and Quality of Life of Breast Cancer Survivors.	NCT03760653	Breast Cancer F...	Physical Exerci... Probiotic group Placebo group	18 Years - 80 Years	Universidad Europea de Madrid
Symbiotics to Prevent Postoperative Infection in Colorectal Cancer	NCT02571374	Colorectal Canc... Surgical Site I...	symbiotic group placebo group	18 Years - 85 Years	Hospital de Clinicas de Porto Alegre
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.	NCT03753334	Prostate Cancer	MAG-EPA Placebo group	18 Years - 100 Years	CHU de Quebec-Universite Laval
Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis	NCT03717961	Raynaud Phenome...	BOTOX® solution Placebo group	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for placebo group