AzTrials
AzTrials

GastroEsophageal CancerRADICESNCT06138223

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

A study testing Exercise intervention and Nutrition intervention in people with GastroEsophageal Cancer and Incurable Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 22 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
GastroEsophageal Cancer, Incurable Disease
What is being tested?
Exercise intervention and Nutrition intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
22 sitesNetherlands
Study dates
1 Jan 2024to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Incurable adenocarcinoma of the esophagus or stomach
  • Recurrence after treatment with curative intent or irresectable/metastatic disease at primary diagnosis. Inclusion can take place regardless of the plan or the actual initiation of multi-line systemic treatment. (i.e. patients that have already started with anticancer therapy are eligible for inclusion too)*
  • Able and willing to perform the exercise and nutritional program and wear the activity tracker.
  • Able and willing to fill out the POCOP/RADICES questionnaires.
  • Life expectancy > 12 weeks.
  • Age ≥ 18 years.

Who cannot join

  • Unstable bone metastases inducing skeletal fragility as determined by the treating clinician.
  • Untreated symptomatic known brain metastasis.
  • Serious active infection.
  • Too physically active (i.e. >210 minutes/week of moderate-to-vigorous intentional exercise) or engaging in intense exercise training comparable to the RADICES exercise program.
  • Severe neurologic or cardiac impairment according to the American College of Sports Medicine criteria.
  • Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise.
Show all 14Show fewer
  • Uncontrolled severe pain.
  • Any other contraindications for exercise as determined by the treating physician.
  • Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician.
  • Pregnancy.
  • Note:
  • After one year of recruitment we broadened our inclusion criteria from GAC patients receiving beyond first-line palliative treatment or best supportive care to any patient with recurrence/progression of GAC after curative treatment or irresectable/metastatic disease at diagnosis, regardless of timing or type of palliative treatment and number of lines received. This was done to increase generalizability and offer the intervention earlier in the palliative phase to enhance its benefits. We acknowledge this results in a more heterogeneous group, but we believe also a more representative group.
  • The inclusion criterium before broadening was:
  • Progressive disease after first-line palliative systemic treatment OR within 6 months after completion of curative treatment (i.e. within six months after neoadjuvant chemoradiation, adjuvant nivolumab, or definitive chemoradiation for esophageal adenocarcinoma or within six months after adjuvant 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) for gastric/esophageal cancer or neoadjuvant FLOT if no adjuvant FLOT was given, or after progression during participation in the LyRICX study). Patients on capecitabine monotherapy who are eligible for oxaliplatin reintroduction can be included, too.

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aniek Bonhof, Msc contact

+31627437310

A.Bonhof-3@umcutrecht.nl

22 sites in 1 country

Netherlands22 sites, 21 recruiting

  • Jeroen Bosch Hospital

    's-Hertogenbosch

    Active, not recruiting

  • Flevoziekenhuis

    Almere Stad

    Dirkje Sommeijer, MD

    Recruiting

  • Meander Medical Center

    Amersfoort

    Ruben Goedegebuure, MD

    Not yet recruiting

  • Amsterdam UMC

    Amsterdam, North Holland, 1081HV

    Hanneke van Laarhoven, 020 444 43 21, h.vanlaarhoven@amsterdamumc.nl

    Recruiting

  • Reinier de Graaf

    Delft

    AJ Verschoor

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven

    IEG van Hellemond

    Recruiting

  • Beatrix Hospital

    Gorinchem

    Marjan Davidis-van Schoonhoven, MD

    Recruiting

  • Spaarne Gasthuis

    Hoofddorp

    A Beeker, Dr

    Recruiting

  • Frisius Medical Center

    Leeuwarden

    J Douma, Dr

    Recruiting

  • Leiden Universitair Medisch Centrum

    Leiden

    M Slingerland, Dr

    Recruiting

  • Sint Antonius Hospital

    Nieuwegein

    Karin Herbschleb, MD

    Not yet recruiting

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen

    Johan Janssen, Dr

    Recruiting

  • RadboudUMC

    Nijmegen

    Harm Westendorp, MD

    Recruiting

  • Laurentius Ziekenhuis

    Roermond

    MHW van de Poel, Dr

    Recruiting

  • Bravis Ziekenhuis

    Roosendaal

    S Boudewijns, Dr

    Recruiting

  • Erasmus Medical Center

    Rotterdam

    Bianca Mostert, MD

    Recruiting

  • Ikazia Ziekenhuis

    Rotterdam

    J.C. Drooger, Dr

    Recruiting

  • HagaZiekenhuis

    The Hague

    D Houtsma, Dr

    Recruiting

  • Elisabeth Tweesteden Hospital

    Tilburg

    Laurens Beerepoot, MD

    Recruiting

  • UMC Utrecht

    Utrecht, Utrecht, 3508GA

    Anne May, MaA.M.May@umcutrecht.nl

    Recruiting

  • Diakonessenhuis

    Utrecht

    Not yet recruiting

  • Zaans Medical Center

    Zaandam

    Sandra Bakker, MD

    Recruiting

Other trials in Netherlands

About this study

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.

Read the detailed description

After one year of recruitment we broadened our inclusion criteria from GAC patients receiving beyond first-line palliative treatment or best supportive care to any patient with recurrence/progression of GAC after curative treatment or irresectable/metastatic disease at diagnosis, regardless of timing or type of palliative treatment and number of lines received. Accordingly, we had to alter stratification. The first 23 patients were stratified by: duration of first-line therapy (shorter or longer than 6 months), WHO performance status (0, 1, 2), and intended start of second-line systemic therapy (yes or no). After broadening the criteria, stratification factors were changed to: WHO performance status (0 versus ≥1) and treatment line (first versus second/higher/best supportive care).

Due to the nature of the intervention, it is not possible to blind the patients, the local study nurses, or the investigators to the treatment assignment.

Being tested
Exercise intervention, Nutrition intervention
Keywords
gastroesophageal cancer, GAC, Palliative, exercise intervention, nutritional intervention, Quality of life, QOL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise interventionOther

    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.

  • Nutrition interventionOther

    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). Moreover, an amount of 15-25 grams of protein within 1-2 hours after exercise will be advised, to prevent muscle protein breakdown and enhance muscle protein synthesis.

Study groups in NCT06138223
Study groupRoleWhat they receive
Usual CareNo interventionPatients 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 provide the control patients with written advice on physical activity and diet according to the current guidelines (in short: 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).
Combined exercise and nutritional intervention.ExperimentalIntervention: exercise and nutrition program group
Receives: Other: Exercise intervention; Other: Nutrition intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life (EORTC-QLQ-30) summary score

    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).

    Measured: Baseline, 6 weeks and every 12 weeks up to one year after intervention

Secondary outcomes (23)

  1. Aerobic capacity: MSEC

    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

    Measured: Baseline, 12 weeks

  2. Muscle strength: Hand grip strength

    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.

    Measured: Baseline, 12 weeks

  3. Body composition: Muscle mass

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

    Measured: Baseline, 12 weeks

  4. Body composition: Fat mass

    Fat mass will be measured with the validated InBody Dial H20B Smart Scale. Scale: 1-100 kg

    Measured: Baseline, 12 weeks

  5. Body composition: Weight

    Weight will be measured with the validated InBody Dial H20B Smart Scale. Scale: 0-200 kg

    Measured: Baseline, 12 weeks

  6. Self-reported screening of malnutrition

    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

    Measured: Baseline and every 12 weeks up to one year after intervention

  7. Physical activity

    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.

    Measured: Baseline, 12 weeks

  8. WHO performance status

    Changes in WHO performance status.

    Measured: Baseline and during the intervention, until the end of the intervention (12 weeks).

  9. Quality of life (EORTC-QLQ-30) total score

    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.

    Measured: Baseline, 6 weeks and every 12 weeks up to one year after intervention

  10. Self-reported screening of sarcopenia

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

    Measured: Baseline,12 weeks

  11. Skeletal muscle index

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

    Measured: Baseline, 12 weeks.

  12. Muscle strength: leg press maximal muscle strength

    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

    Measured: Baseline, 12 weeks

  13. Medical effects: Treatment toxicity

    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

    Measured: Baseline up to one year after intervention

  14. Medical effects: percentage of patients starting second-line treatment

    Percentage of patients who have started second-line treatment

    Measured: Baseline up to one year after intervention

  15. Medical effects: dose reductions

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

    Measured: Baseline up to one year after intervention

  16. Medical effects: dose delays

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

    Measured: Baseline up to one year after intervention

  17. Medical effects: duration of systemic therapy

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

    Measured: Baseline up to one year after intervention

  18. Progression-free survival

    Time to progression

    Measured: Baseline up to one year after intervention

  19. Overall survival

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

    Measured: Baseline up to 1 year after intervention.

  20. Patient reported physical activity

    Physical activity will be assessed by the validated and reliable Short Questionnaire to assess health enhancing physical activity (SQUASH) including commuting activities, leisure time activities, household activities, and activities at work and school.

    Measured: Baseline and every 12 weeks up to one year after intervention

  21. Health-related quality of life: physical functioning

    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.

    Measured: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).

  22. Health-related quality of life: role functioning

    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.

    Measured: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).

  23. Health-related quality of life: fatigue

    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.

    Measured: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Jan 2024
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06138223
Sponsor's protocol ID
NL83835.018.23
Acronym
RADICES
Status last verified
May 2026
First submitted
2 Nov 2023
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Vulpen JK, Hiensch AE, van Hillegersberg R, Ruurda JP, Backx FJG, Nieuwenhuijzen GAP, Kouwenhoven EA, Groenendijk RPR, van der Peet DL, Hazebroek EJ, Rosman C, Wijnhoven BPL, van Berge Henegouwen MI, van Laarhoven HWM, Siersema PD, May AM. Supervised exercise after oesophageal cancer surgery: the PERFECT multicentre randomized clinical trial. Br J Surg. 2021 Jul 23;108(7):786-796. doi: 10.1093/bjs/znab078.

    PubMed 33837380

  • van Vulpen JK, Siersema PD, van Hillegersberg R, Nieuwenhuijzen GAP, Kouwenhoven EA, Groenendijk RPR, van der Peet DL, Hazebroek EJ, Rosman C, Schippers CCG, Steenhagen E, Peeters PHM, May AM. Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study: design of a randomized controlled trial. BMC Cancer. 2017 Aug 18;17(1):552. doi: 10.1186/s12885-017-3542-8.

    PubMed 28821284

  • Hiensch AE, Monninkhof EM, Schmidt ME, Zopf EM, Bolam KA, Aaronson NK, Belloso J, Bloch W, Clauss D, Depenbusch J, Lachowicz M, Pelaez M, Rundqvist H, Senkus E, Stuiver MM, Trevaskis M, Urruticoechea A, Rosenberger F, van der Wall E, de Wit GA, Zimmer P, Wengstrom Y, Steindorf K, May AM. Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFECT study. Trials. 2022 Jul 29;23(1):610. doi: 10.1186/s13063-022-06556-7.

    PubMed 35906659

  • Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.

    PubMed 27637832

  • Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

    PubMed 31626055

  • Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW, Sprangers MA, Velikova G, Aaronson NK; EORTC Quality of Life Group. Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. J Clin Epidemiol. 2016 Jan;69:79-88. doi: 10.1016/j.jclinepi.2015.08.007. Epub 2015 Sep 28.

    PubMed 26327487

  • Ligibel JA, Bohlke K, May AM, Clinton SK, Demark-Wahnefried W, Gilchrist SC, Irwin ML, Late M, Mansfield S, Marshall TF, Meyerhardt JA, Thomson CA, Wood WA, Alfano CM. Exercise, Diet, and Weight Management During Cancer Treatment: ASCO Guideline. J Clin Oncol. 2022 Aug 1;40(22):2491-2507. doi: 10.1200/JCO.22.00687. Epub 2022 May 16.

    PubMed 35576506

  • Bonhof A, Hiensch AE, Wierdsma NJ, Huis In 't Veld LF, Bakker SD, Beeker A, Davidis-van Schoonhoven M, Droogendijk H, Drooger JC, Douma JAJ, Goedegebuure RSA, Haj Mohammad N, van Hellemond IEG, Herbschleb K, Janssen JJB, Mostert B, Slingerland M, Sommeijer D, Timmermans L, Verschoor AJ, de Weger VA, Westdorp H, Wumkes ML, May AM, van Laarhoven HWM. Effects of exercise and diet in patients with incurable gastroesophageal cancer: the RADICES study. JNCI Cancer Spectr. 2026 Mar 3;10(2):pkag006. doi: 10.1093/jncics/pkag006.

    PubMed 41592243

Questions about this trial

What is this clinical trial studying?

A study testing Exercise intervention and Nutrition intervention in people with GastroEsophageal Cancer and Incurable Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 22 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aniek Bonhof, Msc (+31627437310, A.Bonhof-3@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (EORTC-QLQ-30) summary score (time frame: Baseline, 6 weeks and every 12 weeks up to one year after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06138223, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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