Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Quality of Life

Esophageal Cancer

Patients randomized to the control group will receive standard medical care, including nutritional care as provided by the center in usual care. Additionally, they receive an activity tracker (like the intervention group) but without specific instructions. We will advise control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150 min/week in line with the current physical activity guidelines.

Intervention: exercise and nutrition program group

During 12 weeks, patients will visit twice a week a trained oncology physiotherapist for one hour per session. This training includes supervised aerobic and resistance exercises to increase aerobic condition and muscle resistance, based on their own fitness level as assessed at baseline. Additionally, physiotherapists will educate participants on how to increase their daily activity. To this end, all participants will receive an activity tracker to monitor their daily activities.

Exercise intervention

Once every two weeks patients in the intervention group will receive a nutritional assessment and intervention by a trained dietician for optimization of their nutritional intake to improve their nutritional status, following the ESPEN guideline on nutrition in cancer patients and the national guidelines of the National Nutritionists Oncology Working Group (NNOWG; in Dutch: Landelijke Werkgroep Diëtisten Oncologie, LWDO).

Nutrition intervention

Hanneke van Laarhoven

The survival of patients with incurable gastroesophageal cancer can extend over a year with anticancer therapy. However, the number of patients with deteriorating quality of life in this patient group steadily decreases over time during the treatment. Potentially reversible causes related to deterioration of quality of life are diminished muscle mass, physical capacity and nutritional status. Therefore, interventions that can target these in order to maintain or improve quality of life are urgently needed.

However, it is yet unknown whether improvement of physical capacity and nutritional status improves quality of life in patients with incurable gastroesophageal adenocarcinoma after failure of first-line treatment. Since these patients are in a precarious situation, the benefits and harms of a combined exercise and nutritional intervention should be carefully evaluated.Therefore this study investigates the effect of a combined exercise and nutrition intervention compared to usual care on quality of life in incurable GAC patients after progression upon first-line treatment.

A total of 196 patients with metastasized gastroesophageal cancer will be recruited and randomly allocated 1:1 to standard care or standard care plus a combined exercise and nutritional intervention.

The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)

Intervention group only. SAE will be recorded during trial visits and through medical records. This procedure will concern SAE's potentially related to the exercise intervention during the trial period.

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item. The summary score encompasses the last question of this questionnaire.

Scale: 1-7 Higher score means better quality of life.

Analyzed will be the difference in quality of life between the intervention group and the control group at 12 weeks, taking into account the baseline values, and measured with the Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).

Changes in MSEC (= maximum short exercise capacity or in other words maximum wattage in the steep ramp test).

In the steep ramp test participants cycle with a pedal frequency between 70 and 80 rpm 30 seconds at 25 W. Then every 10 seconds, the load is increased with 25 W until exhaustion. The test ends when pedal frequency falls below 60 rpm. From the MSEC peak Wattage (Wpeak) can be estimated using a regression equation.

Scale: 0-500 W

Changes in hand grip strength. Hand grip strength: using a handgrip dynamometer the participant will be asked to squeeze the dynamometer as hard as possible for three times, for both hands. The best of three attempts for bot hands is recorded.

Scale: 0-100 kg.

Muscle mass will be measured with the validated InBody Dial H20B Smart Scale. Scale: 0-100 kg

Weight will be measured with the validated InBody Dial H20B Smart Scale. Scale: 0-500 kg

Malnutrition will be screened using the short-form Abridged Scored Patient-Generated Subjective Global Assessment (abPG-SGA).

Scale: 0-50 Higher score is more malnourished

Physical activity is measured by an activity tracker (Fitbit). Participants are instructed to wear the tracker for 12 weeks. Mean daily steps and minutes spent in different intensity levels of physical activity are calculated, excluding no-wear days.

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item.

Changes in total quality of life. Scale: 0-100 Higher score means better quality of life.

Changes in sarcopenia will be assessed using the Sarc-F questionnaire. (Scale 0-10, higher the score the better the condition).

Changes in skeletal muscle index, assessed by diagnostic CT-scans.

Changes in leg press one repetition maximum (1RM). Leg strength: the 12 repetition maximum is the maximum weight with which exactly 12 repetitions of a defined exercise/movement sequence can be performed with clean technique. Afterwards, the so called hypothetical 1RM (h1RM) can be calculated.

Scale: 0-200 kg

Changes in treatment toxicity in case of start of second line systemic treatment will be assessed using the Common Terminology Criteria for Adverse Events version 5.0

Percentage of patients who have started second-line treatment

Treatment tolerance assessed by the amount of delivered second-line systemic treatment doses.

Treatment tolerance assessed by the number of dose delays of second-line systemic treatment.

Treatment tolerance assessed by the total duration of second-line systemic treatment.

Proportion of patients who have not died 1 year after baseline.

Changes in patient-reported physical activity as assessed by the Short Questionnaire to assess health enhancing physical activity (SQUASH).

Changes in physical functioning, element of the EORTC-QLQ-30. To improve measurement precision compared to the standard, static EORTC-QLQ-C30 questionnaire, and to avoid floor- and ceiling effects, physical functioning will be assessed using computer adaptive testing in collaboration with experts of the EORTC.

Changes in role functioning, element of the EORTC-QLQ-30. To improve measurement precision compared to the standard, static EORTC-QLQ-C30 questionnaire, and to avoid floor- and ceiling effects, role functioning will be assessed using computer adaptive testing in collaboration with experts of the EORTC.

Changes in fatigue, element of the EORTC-QLQ-30. To improve measurement precision compared to the standard, static EORTC-QLQ-C30 questionnaire, and to avoid floor- and ceiling effects, fatigue will be assessed using computer adaptive testing in collaboration with experts of the EORTC.

UMC Utrecht

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Head of Medical Oncology of Amsterdam AMC, Principal Investigator, Prof. dr. H.W.M. van Laarhoven

Participants clinical history, available therapeutic options, and outcome expectations will be presented to the Evolutionary Tumor Board (ETB) along with images and pathology. Strategies and models will be presented regarding additional evolutionary ideas that can be applied.

The ETB consists of evolutionary biologists, mathematicians, research scientists, statisticians,data scientists, radiologists, pathologists, oncologists (surgical, radiation, medical, and pediatric), and clinical trial coordinators.The ETB will generate hypotheses, mathematical models, and experiments from the discussion towards further integration of evolutionary ideas towards therapeutic strategies for participants. The ETB will collect data through a chart review regarding adherence and results of ETB recommendation

Evolutionary Tumor Board (ETB)

Alaa Taha

Christine Chung, MD

Joel Brown, PhD

Alexander Anderson, PhD

Michael Schell, PhD

This study will evaluate the ability of a multidisciplinary group, the Evolutionary Tumor Board (ETB), to develop therapeutic strategies in patients without curative options.

Peripheral blood collected, and subsequently at designated time points (every 9 weeks from ETB result discussion +/- 4 weeks) depending on the upfront treatment protocol, off therapy, and at disease relapse. For each collection, a total of 20 mL of blood will be drawn, which includes 10 ml of blood in an EDTA tube, and 10 ml in a LBGuard® tube, as described in Lab Manual.

Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board

Feasibility of Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board in Cancer Patients

The investigators want to demonstrate the ability of a multidisciplinary group, the ETB, to develop therapeutic strategies in participants without curative options. They plan to enroll 35 patients to this study over 3 years. The primary objective will be successfully met if they can develop an evolutionary based plan that differs from the participants options prior to presentation for at least 80%, or 28 of these participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)	NCT06138223	GastroEsophagea... Incurable Disea...	Exercise interv... Nutrition inter...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board	NCT04343365	Incurable Disea...	Evolutionary Tu...	-	H. Lee Moffitt Cancer Center and Research Institute

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