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

NCT06138223 | Recruiting

• 1 other identifier: NL83835.018.23
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

GastroEsophageal Cancer; Incurable Disease

Keywords

gastroesophageal cancer; GAC; Palliative; exercise intervention; nutritional intervention; Quality of life; QOL

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (23)

• Aerobic capacity: MSEC

  Baseline, 12 weeks

• Muscle strength: Hand grip strength

  Baseline, 12 weeks

• Body composition: Muscle mass

  Baseline, 12 weeks

• Body composition: Fat mass

  Baseline, 12 weeks

• Body composition: Weight

  Baseline, 12 weeks

Other Outcomes (3)

• (Serious) Adverse Events potentially related to the exercise intervention

  Baseline until the end of intervention (12 weeks)

• Adherence and compliance to the exercise and diet intervention

  During the intervention period of 12 weeks

• Satisfaction with the exercise and nutritional intervention

  Post-intervention (12 weeks)

Study Arms (2)

Usual Care

NO INTERVENTION

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 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.

EXPERIMENTAL

Intervention: exercise and nutrition program group

Other: Exercise intervention; Other: Nutrition intervention

Interventions

Exercise intervention OTHER

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.

Combined exercise and nutritional intervention.

Nutrition intervention OTHER

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.

Combined exercise and nutritional intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incurable adenocarcinoma of the esophagus or stomach.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• UMC Utrecht: collaborator

Study Sites (12)

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Reinier de Graaf

Delft, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

NOT YET RECRUITING

Spaarne Gasthuis

Hoofddorp, Netherlands

ACTIVE NOT RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

ACTIVE NOT RECRUITING

Leiden Universitair Medisch Centrum

Leiden, Netherlands

NOT YET RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

Laurentius Ziekenhuis

Roermond, Netherlands

RECRUITING

Bravis Ziekenhuis

Roosendaal, Netherlands

ACTIVE NOT RECRUITING

Ikazia Ziekenhuis

Rotterdam, Netherlands

RECRUITING

HagaZiekenhuis

The Hague, Netherlands

NOT YET RECRUITING

UMC Utrecht

Utrecht, 3508GA, Netherlands

RECRUITING

Related Publications (7)

• 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.

  PMID: 33837380 BACKGROUND

• 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.

  PMID: 28821284 BACKGROUND

• 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.

  PMID: 35906659 BACKGROUND

• 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.

  PMID: 27637832 BACKGROUND

• 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.

  PMID: 31626055 BACKGROUND

• 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.

  PMID: 26327487 BACKGROUND

• 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.

  PMID: 35576506 BACKGROUND

Related Links

• national guidelines of the National Nutritionists Oncology Working Group (NNOWG; in Dutch: Landelijke Werkgroep Diëtisten Oncologie, LWDO)

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Hanneke van Laarhoven

  Amsterdam AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aniek Bonhof, Msc

CONTACT

+31627437310; A.Bonhof-3@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Oncology of Amsterdam AMC, Principal Investigator, Prof. dr. H.W.M. van Laarhoven

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (12)