Neoplasms

Digestive System Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Rare Diseases

Colorectal Neoplasms

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Adenocarcinoma

Intestinal Obstruction

Peritoneal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Peritoneal Diseases

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Acute Graft Versus Host Disease

All eligible participants will be assessed by a specialist dietitian and a diet history and symptoms will be recorded. Depending on the degree of sub-acute bowel obstruction, symptoms and type of diet being followed, patients will be given detailed instructions on which stage of the 4 stage diet to use. They will be followed up by telephone or face to face weekly for a 4 week period and shown how to alter their diet by moving up and down the stage of the diet if symptoms resolve or worsen. This is current standard of care.

Additional assessments will be carried out at the start and end of the study when participants will complete the Memorial Symptom Assessment Scale (MSAS) and EORTC QLQ-30 quality of life questionnaire. They will be asked to complete a daily diet diary, and an 'ease of use' questionnaire at the end of the 4 week period.

To determine whether a 4 stage bowel obstruction diet as a means of managing oral intake in patients symptomatic with malignant sub-acute bowel obstruction (SBO) is deliverable and effective in clinical practice.

Dietary intervention

Lindsey Allan

Agnieszka Michael

Bowel obstruction is a common complication in patients with ovarian, peritoneal and bowel cancer due to a mass or spread of disease, causing narrowing to the gut, as these cancers can grow on the bowel surface. Certain foods may lead to symptoms such as pain, bloating, feeling full, feeling sick, vomiting and difficulty passing a bowel motion.

There is limited evidence to establish the best diet to follow when someone is diagnosed with the risk of bowel obstruction and is experiencing symptoms after eating and drinking.

The Dietitians at the Royal Surrey have developed a 4 stage bowel obstruction diet which they have been using with patients for 3 years. The 4 stages are clear fluids, all thin liquids, low fibre soft smooth diet, low fibre soft sloppy diet. Depending on the severity of symptoms and the risk of a blockage, patients are asked to follow a certain stage of the diet. They are advised to move up and down the stages as symptoms improve or get worse.

This feasibility study aims to investigate if the diet can be used and is effective in clinical practice. The objectives are to see if this diet is easy to follow, can reduce symptoms of bowel obstruction, can improve quality of life, and reduce admissions to hospital because of bowel blockages.

Patients at risk of bowel obstruction from colorectal or ovarian cancer are eligible to participate. They will remain in the study for a period of 4 weeks, during which time they will be asked to complete a diet diary and 3 questionnaires.

Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet

BOUNCED: Managing Oral Diet Following a Diagnosis of Sub-acute Bowel Obstruction: a Feasibility Study Exploring the Efficacy of a 4 Stage Bowel Obstruction Cancer Diet and Quality of Life in Cancer Patients

Measured by completion of the Memorial Symptom Assessment Scale questionnaire (MSAS): a well-validated questionnaire, which asks about the frequency, severity and psychological effect of 32 symptoms. For the purpose of this study, the MSAS has been adapted to include the key additional symptom of early satiety (feeling full up quickly) that can be experienced by patients with sub-acute bowel obstruction. It is graded on a scale of 0 (not at all) - 4 (very much).

No of hospital admissions and A\&E attendances due to bowel obstruction in the 3 months prior to consent will be recorded. This will be compared with the number of admissions during the 4 weeks patients are on the trial.

Measured by using the EORTC Quality of Life QLQ-C30 questionnaire will be collected at baseline on entry to the study and after 4 weeks on completion of the study. QLQ-C30 developed by EORTC is designed to measure cancer patients' physical, psychological and social functions. It is scored on a scale from 0 (not at all) - 4 (very much).

Measured in kilograms and as a percentage indicating percentage weight change from start to end of the trial. Participants will be weighed on consent and after 4 weeks.

Royal Surrey County Hospital NHS Foundation Trust

Skin and Connective Tissue Diseases

Prostatic Neoplasms

Breast Neoplasms

Carcinoma, Renal Cell

Kidney Neoplasms

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Lipid Regulating Agents

All Drugs and Chemicals

Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

20 patients from each type of cancer (altogether 80) are randomized to a 3 months guided physical exercise arm. At the beginning of the intervention the patients' physical condition and body composition are measured. After that an exercise program begins. All subjects participate in physical exercise program twice a week for three months. At the end of the intervention, the physical condition and body composition are measured again. During the follow-up after the intervention the patients are advised to exercise regularly. Physical condition and body composition are measured again after 6 months. Exercise activity is asked during each follow-up visit.

In addition, as a separate group, 20 patients from each type of cancer (altogether 80) who are already using statin medication are randomized to this arm.

20 patients from each type of cancer (altogether 80) are randomized to a 3 months guided physical exercise + atorvastatin (40 mg QD) arm. At the beginning of the intervention the patients' physical condition and body composition are measured. After that an exercise program begins. All subjects participate in physical exercise program twice a week for three months. At the end of the intervention, the physical condition and body composition are measured again. During the follow-up after the intervention the patients are advised to exercise regularly. Physical condition and body composition are measured again after 6 months. Exercise activity is asked during each follow-up visit.

20 patients from each type of cancer (altogether 80) are randomized to a non-guided physical exercise arm. The patients' physical condition and body composition are measured at baseline. The control group is advised of the benefits of physical exercise and they get an exercise program to follow. Participants in the control group exercise on their own. The physical condition and body composition of this group is also measured at three months and six months after baseline to detect changes. After that the patients are given advise to exercise regularly and this is asked during each follow-up visit.

In addition, as a separate group, 20 patients from each type of cancer (altogether 80) who are already using statin medication are randomized to this arm.

Patients will be participating in guided physical exercise program regularly two times / week at a sports facility and guided by a professional trainer. They will participate in aerobic and resistance exercises during the sessions.

Guided physical exercise

Patients will be participating in guided physical exercise program regularly two times / week at a sports facility and guided by a professional trainer. They will participate in aerobic and resistance exercises during the sessions. In addition to the exercise program they will be given atorvastatin 40 mg QD medication.

The control group is advised of the benefits of physical exercise and they get an exercise program to follow. Participants in the control group exercise on their own.

Independent exercise

Teemu Murtola, MD PhD Prof

Jorma Sormunen, MD PhD MBA

The aim of the study is to find out whether supervised physical exercise during cancer drug treatment improves the effectiveness of the treatment in metastasized breast, kidney, ovarian and prostate cancer compared to unsupervised exercise. In addition, the investigators are investigating whether the use of atorvastatin combined with guided group exercise training would further improve the response to cancer treatment.

Despite the marked differences between different malignancies' genetic, metabolic, and prognostic factors, hypoxia and adaptation of metabolic changes favoring hypoxic microenvironment are common factors in most solid tumors. Hypoxic microenvironment provides cancer cells multiple advantages: protection from immune system, somatic mutations leading to more aggressive form of cancer, and cancer cells that are adjusted to hypoxic conditions are more prone to form metastases. One possible mechanism for cancer cell to adjust to hypoxic microenvironment is related to lipid metabolism; lipids are known to accumulate into cancer cells in many cancer types. One of the most promising ways to reduce hypoxia in solid tumors is to increase physical exercise. Furthermore, tumors' lipid metabolism can be affected by treatment with cholesterol-lowering statins, which decreases serum cholesterol levels and inhibits cancer cells' own lipid synthesis.

The aim of this randomized clinical trial is to investigate if supervised group exercise will improve response to cancer drug treatment in metastasized breast, kidney, prostate, and ovarian cancer compared to unsupervised exercise. The investigators will also evaluate if atorvastatin treatment in combination with guided group exercise can promote even better treatment responses than exercise alone. Exercise program includes aerobic and resistance training.

This study is a randomized phase III pilot study testing the research hypothesis for the first time in humans. In the pilot phase of the study, a total of 240 cancer patients (n=60/cancer type) will be recruited into the study and randomized 1:1:1 into three different groups, i.e. 20 people in each group from each cancer type:

1. 3 months of supervised group exercise
2. 3 months of supervised group exercise and at the same time atorvastatin 40 mg/day
3. to a control group that exercises voluntarily without guidance

In addition, as a separate group, a total of 160 cancer patients (40/cancer type) who are already using statin medication will be recruited for the study and randomized 1:1 into two groups: 1) 3 months of supervised group exercise and 2) independent exercise (a control group that exercises voluntarily without guidance).

Before the study begins, the patients are informed orally and in writing about the study. The patients who agree to participate in the study sign an informed consent.

The patient follow-up time in each group is two years in 3 months intervals (first visit and 8 follow-up visits) in conjunction with standard cancer treatment follow-up visits. Blood and urine samples and questionnaire data are collected at baseline and at each follow-up visit. Body composition and physical performance are measured at baseline and twice after the intervention. Patients QoL and experiences of exercise are measured in qualitative interviews (in the group participating the qualitative sub-study).

The main response variables are

1. cancer progression during cancer treatment based on imaging, symptoms or laboratory findings and
2. mortality of the patients.

   The other variables of interest in this study are:
3. whether exercise alone reduces hypoxia sufficiently to improve the effectiveness of cancer chemotherapy, and whether inhibiting lipid synthesis with a statin enhances this effect.
4. to evaluate the patient's experiences of cancer drug treatment, their side effects and the effects of increasing exercise on the patient's perceived quality of life, perceived pain, depressive symptoms, nutrition and relationships.

Adverse events from cancer treatment and treatment interruptions are also monitored.

The patients are randomized equally into three groups: 1/3 into guided exercise group, 1/3 into guided exercise and statin-treatment group and 1/3 into non-guided exercise group

Measuring Oncological Value of Exercise and Statin

Syöpäpotilaan Ennusteen Parantaminen Muuttamalla syövän mikroympäristöä ja Metaboliaa Liikunnalla ja lääkkeellisesti - Measuring Oncological Value of Exercise and Statin

Radiological progression • Radiological progression of the disease according to RECIST criteria (version 1.1.) compared to the situation at the start of cancer treatment in all cancer types. If the cancer treatment includes the use of immune checkpoint inhibitors, the imRECIST criteria are applied to evaluate the response

In addition, the disease is considered advanced if both of the criteria below are met:

* Biochemical progression:

  * PSA progression in prostate cancer, (three consecutive PSA increases measured at least one week apart, two \> 50% increases from the lowest PSA level and PSA \> 2 ng/ml) with testosterone at castration level (\< 50 ng/ml or 1.7 nmol/l)
  * Ca15-3 marker increase in breast cancer (three consecutive marker increases that the clinician considers significant)
  * In ovarian cancer, ca12-5 marker increase (three consecutive marker increases that the clinician considers significant)
* Clinical progression o ECOG 3 or less (long-term)

Time to death from the beginning of the first-line medication

Incidence of grade 3 or worse adverse events during cancer treatment

Body composition measurement before and after the intervention

Muscle strength tested with three standardized tests (squat test, core dynamic strength test, biceps flexion test) before and after the intervention.

The amount of hypoxia in cancer foci determined by PET-CT scan using specific hypoxia-sensitive tracers in a sub-study

EORTC-QLQ-C30 questionnaire to measure quality of life, score from 0 to 100. A high scale score for a functional scale represents a higher level of functioning, a high score for a symptom scale represents higher level of symptoms.

Patient Health Questionnaire (PHQ-9), score from 0 (no depression) to 27 (severe depression).

The severity of pain and its impact on functioning. Brief Pain Inventory questionnaire including 9 items. Pain severity scale from 0 (no pain) to 10 (worst pain), pain interference from 0 (does not interfere) to 10 (completely interferes).

Mini Nutritional Assessment (MNA) questionnaire. A score of 7 or less (malnutrition) to 24-30 (normal nutrition).

The relationship questionnaire consists of two previously used, validated measures: Dyadic Adjustment Scale (DAS) and Marital Communication Inventory.

Tampere University

Aalto University

University of Helsinki

University of Turku

Tampere University Hospital

Professor of Urology, Chief Physician

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Pancreatic Neoplasms

Stomach Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Esophageal Cancer

Pancreatic Cancer

Stomach Cancer

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Antineoplastic Agents, Immunological

Part I- Dose escalation:

Escalating dose levels of IPH5301 will be evaluated.

Part II-Cohort Expansion:

IPH5301 will be administrated in combination with trastuzumab and paclitaxel

Part I-Dose escalation Patients will receive IPH5301 alone on day 1 (Week 1). Treatment will be administered every 2 weeks until progression or unacceptable toxicity or other reasons requiring treatment discon-tinuation, for a maximum duration of 12 months.

Part II- Expansion cohort Patients will receive IPH5301 at a recommended dose (RP2D) or a next lower dose (RP2D-1)in combination with trastuzumab and paclitaxel, at day 1 and every 2 weeks up to 6 cycles of paclitaxel. The RP2D dose will not exceed the designated maximum tolerated dose (MTD).

IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB

DOMINIQUE GENRE

Anthony Gonçalves, MD PhD

Anthony GONCALVES, MD PhD

CHANCES-IPC 2021-008 is First In Human, Phase I, multicenter, European study evaluating an anti-CD73, IPH5301 in advanced and/or metastatic cancer.

The trial will be conducted in two parts, Part I- Dose escalation: This part aims to identify the maximum tolerated dose (MTD) of IPH5301 agent in monotherapy and recommended phase 2 dose (RP2D) for future trials, followed by a safety expansion study part cohort.

Part II- Expansion cohort: A total of 12 HER2+ cancer patients, respectively 6 breast cancer patients and 6 gastric cancer patients, is planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.

A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors

DLTs would include any grade 3 toxicity or higher that occurs during the first 4 weeks from the first injection of IPH5301, with the some exceptions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet	NCT04898842	Colorectal Canc... Colorectal Neop... Colorectal Carc... Colorectal Aden... Colorectal Canc... Ovarian Cancer Ovarian Neoplas... Metastatic Colo... Metastatic Ovar... Peritoneal Carc... Bowel Obstructi...	Dietary interve...	18 Years -	Royal Surrey County Hospital NHS Foundation Trust
Measuring Oncological Value of Exercise and Statin	NCT05796973	Prostate Cancer Breast Cancer Kidney Cancer Ovarian Cancer Metastatic Brea... Metastatic Kidn... Metastatic Rena... Metastatic Rena... Metastatic Pros... Metastatic Pros... Metastatic Ovar... Metastatic Ovar...	Guided physical... Atorvastatin Independent exe...	18 Years - 99 Years	Tampere University Hospital
Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet	NCT04898842	Colorectal Canc... Colorectal Neop... Colorectal Carc... Colorectal Aden... Colorectal Canc... Ovarian Cancer Ovarian Neoplas... Metastatic Colo... Metastatic Ovar... Peritoneal Carc... Bowel Obstructi...	Dietary interve...	18 Years -	Royal Surrey County Hospital NHS Foundation Trust
A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors	NCT05143970	Metastatic Canc... Metastatic Brea... Metastatic Panc... Metastatic Gast... Metastatic Lung... Metastatic Ovar... Oesophageal Can... Endometrial Can... Advanced Solid ...	IPH5301 ALONE O...	18 Years -	Institut Paoli-Calmettes

Spots Global Cancer Trial Database for metastatic ovary cancer