The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES) (RADICES)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06138223 |
|
Recruitment Status :
Active, not recruiting
First Posted : November 18, 2023
Last Update Posted : November 18, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| GastroEsophageal Cancer Incurable Disease | Other: Exercise intervention Other: Nutrition intervention | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 196 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES) |
| Actual Study Start Date : | October 1, 2023 |
| Estimated Primary Completion Date : | September 30, 2028 |
| Estimated Study Completion Date : | September 30, 2028 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Usual Care
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.
|
|
|
Experimental: Combined exercise and nutritional intervention.
Intervention: exercise and nutrition program group
|
Other: Exercise intervention
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. Other: Nutrition 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). |
- Quality of life (EORTC-QLQ-30) summary score [ Time Frame: Baseline, 6 weeks and every 12 weeks up to one year after intervention ]
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).
- Aerobic capacity: MSEC [ Time Frame: Baseline, 12 weeks ]
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
- Muscle strength: Hand grip strength [ Time Frame: Baseline, 12 weeks ]
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.
- Body composition: Muscle mass [ Time Frame: Baseline, 12 weeks ]Muscle mass will be measured with the validated InBody Dial H20B Smart Scale. Scale: 0-100 kg
- Body composition: Weight [ Time Frame: Baseline, 12 weeks ]Weight will be measured with the validated InBody Dial H20B Smart Scale. Scale: 0-500 kg
- Self-reported screening of malnutrition [ Time Frame: Baseline and every 12 weeks up to one year after intervention ]
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 [ Time Frame: Baseline, 12 weeks ]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.
- WHO performance status [ Time Frame: Baseline and during the intervention, until the end of the intervention (12 weeks). ]Changes in WHO performance status.
- Quality of life (EORTC-QLQ-30) total score [ Time Frame: Baseline, 6 weeks and every 12 weeks up to one year after intervention ]
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.
- Self-reported screening of sarcopenia [ Time Frame: Baseline,12 weeks ]Changes in sarcopenia will be assessed using the Sarc-F questionnaire. (Scale 0-10, higher the score the better the condition).
- Skeletal muscle index [ Time Frame: Baseline, 12 weeks. ]Changes in skeletal muscle index, assessed by diagnostic CT-scans.
- Muscle strength: leg press maximal muscle strength [ Time Frame: Baseline, 12 weeks ]
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
- Medical effects: Treatment toxicity [ Time Frame: Baseline up to one year after intervention ]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
- Medical effects: percentage of patients starting second-line treatment [ Time Frame: Baseline up to one year after intervention ]Percentage of patients who have started second-line treatment
- Medical effects: dose reductions [ Time Frame: Baseline up to one year after intervention ]Treatment tolerance assessed by the amount of delivered second-line systemic treatment doses.
- Medical effects: dose delays [ Time Frame: Baseline up to one year after intervention ]Treatment tolerance assessed by the number of dose delays of second-line systemic treatment.
- Medical effects: duration of systemic therapy [ Time Frame: Baseline up to one year after intervention ]Treatment tolerance assessed by the total duration of second-line systemic treatment.
- Progression-free survival [ Time Frame: Baseline up to one year after intervention ]Time to progression
- Overall survival [ Time Frame: Baseline up to 1 year after intervention. ]Proportion of patients who have not died 1 year after baseline.
- Patient reported physical activity [ Time Frame: Baseline and every 12 weeks up to one year after intervention ]Changes in patient-reported physical activity as assessed by the Short Questionnaire to assess health enhancing physical activity (SQUASH).
- Health-related quality of life: physical functioning [ Time Frame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks). ]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.
- Health-related quality of life: role functioning [ Time Frame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks). ]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.
- Health-related quality of life: fatigue [ Time Frame: Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks). ]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.
- (Serious) Adverse Events potentially related to the exercise intervention [ Time Frame: Baseline until the end of intervention (12 weeks) ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Incurable adenocarcinoma of the esophagus or stomach.
- 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 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). Patients on capecitabine monotherapy who are eligible for oxaliplatin reintroduction can be included, 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.
- Age ≥ 18 years.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06138223
| Netherlands | |
| Amsterdam UMC | |
| Amsterdam, Noord-Holland, Netherlands, 1081HV | |
| UMC Utrecht | |
| Utrecht, Netherlands, 3508GA | |
| Principal Investigator: | Hanneke van Laarhoven | Amsterdam AMC |
Publications:
| Responsible Party: | Hanneke W. M. van Laarhoven, Head of Medical Oncology of Amsterdam AMC, Principal Investigator, Prof. dr. H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT06138223 |
| Other Study ID Numbers: |
NL83835.018.23 |
| First Posted: | November 18, 2023 Key Record Dates |
| Last Update Posted: | November 18, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |