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ObesityCANOBESENCT07058207

Weight Management in Obese Cancer Patients During Curative Active Treatment

A study testing Multimodal weight management program in people with Obesity and Solid Neoplasm, run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Spain.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This is a feasibility study intervention to fifty cancer patients with obesity and with newly diagnosed stage II-IV solid tumors undergoing curative treatment recruited at the Catalan Institute of Oncology (ICO) in L'Hospitalet, Spain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Solid Neoplasm, Stage II-IV
What is being tested?
Multimodal weight management program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
22 Jul 2025to Mar 2027
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

  • Adult (age 18+) with pathologically confirmed malignant solid tumors, stage II-IV, elected for oncological treatment (chemo, radio, or both) with curative intend.
  • Expected oncological treatment time ≥ 3 months.
  • BMI ≥ 30 kg/m²
  • Resident in the Barcelona area up to the completion of cancer treatment.
  • ECOG Perfomance Status (PS) 0-1
  • Availability of internet access.

Who cannot join

  • Patients with melanoma and brain tumours.
  • Surgery as the only treatment.
  • Tumour localizations with high risk of malnutrition (such as head and neck, upper gastrointestinal tract, or pancreatic cancer):
  • Pregnancy or breastfeeding
  • Another active malignancy
  • Current health or medical condition that affects weight status, e.g., untreated hyper- or hypothyroidism,etc
Show all 13Show fewer
  • Pre-existing medical condition that precludes adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, bone metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-months.
  • Unable to read or understand Spanish or Catalan
  • Enrolled in a weight loss program
  • Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence)
  • Use of pacemaker or another electrical implanted device
  • History of bariatric (or LapBand) surgery, or considering or currently on a wait-list for bariatric or LapBand surgery
  • Patients with any concurrent medical or psychological condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.

Trial locations and contacts

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

Lorena Arribas contact

+34932607751

larribas@iconcologia.net

Marta Puig contact

+34932607751

mpuig@iconcologia.net

Spain1 site, 1 recruiting

  • Institut Català d'Oncologia. Catalan Institute of Oncology

    L'Hospitalet de Llobregat, Barcelona, 08908

    Lorena Arribas, +34932607751, larribas@iconcologia.net

    Recruiting

Other trials in Spain

About this study

Official title: Weight Management in Obese Cancer Patients During Curative Active Treatment (CANOBESE Study): A Feasibility Study

This is a feasibility study intervention to fifty cancer patients with obesity and with newly diagnosed stage II-IV solid tumors undergoing curative treatment recruited at the Catalan Institute of Oncology (ICO) in L'Hospitalet, Spain.

The investigators hypothesize that weight management during cancer treatment could enhance health outcomes for this population. The feasibility of a multimodal weight loss management program will be assesses, including a personalized hypocaloric and high-protein diet combined with a supervised exercise home-program and behavioural support.

Read the detailed description

The single-arm intervention will consist of a multimodal weight management program, including a personalized hypocaloric and high-protein diet combined with a supervised exercise home-program and behavioural support. Hypocaloric diet will be individualized according to their energy requirements estimated and then applying a 20% caloric restriction. In order to reduce body weight and maintain muscle mass, a high-protein diet will be provided consisting of 1.5 g of protein/kg/day.

Participants will be provided with a 3-day food record (3-DFR) chart prior to their baseline visit. After a full nutritional evaluation, the dietitian will create a diet plan unique to the participant. For those participants struggling to attain their recommended intake or anticipating protein intake to be challenging, an oral whey powder supplement will be provided for the duration of the study. Additional approaches to overcoming dietary challenges will include information/resources on nutritional symptom management that can impact dietary intake and/or high-protein recipes.

The exercise program will be based on supervised aerobic and resistance exercise home-based training sessions 3 times/week. The sessions will be 60 minutes long and will include 5 minutes of flexibility, followed by 25 minutes of aerobic exercises, 25 minutes of resistance exercises, and 5 minutes of balance exercises. The physiotherapist will supervise the sessions and will provide monthly individual face-to-face counselling to assure adherence to the protocol. The investigators have designed an individualized exercise program that fits the current patient's clinical situation. Each patient will receive a fitness tracker band to monitor his/her activity.

Behavioural support will include problem-solving strategies and practical tools to facilitate participants' self-control on emotional eating or stress-driven behaviours. Targeted behaviour goals will be set. A psychologist will provide technical support and training to the dietitian and the physiotherapist to improve their skills to provide behavioural changes and motivation.

Being tested
Multimodal weight management program
Keywords
Obesity, Neoplasms, Antineoplasic agents, Chemotherapy, Radiotherapy, Weight Loss, Physical Activity, Feasibility Studies, Patient Compliance, Patient Motivation, Patient Adherence, Patient Dropouts, Treatment-related adverse effects, Biomarkers, nutritional intervention, curative-intent treatment
Medical subject headings
Obesity, Neoplasms, Weight Loss, Motor Activity, Patient Compliance, Patient Dropouts

What participants receive

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

  • Multimodal weight management programBehavioural

    This intervention consists of three components:

    • Nutritional Counseling:
    • A personalized hypocaloric and high-protein diet is prescribed, based on individual energy requirements with a 20% caloric reduction.
    • The protein intake target is 1.5 g/kg/day to promote fat loss while maintaining muscle mass.
    • Exercise Program
    • Home-based, supervised aerobic and resistance training sessions conducted 3 times per week.
    • Each 60-minute session includes: 5 minutes flexibility, 25 minutes aerobic training, 25 minutes resistance training, and 5 minutes balance exercises.
    • Behavioral Support
    • Patients receive training in problem-solving strategies, motivation, and emotional self-regulation to improve adherence to both dietary and exercise goals.
    • Health professionals delivering the intervention are trained in behavior change techniques by a clinical psychologist.
Study groups in NCT07058207
Study groupRoleWhat they receive
Cancer patients with obesity with active curative treatmentExperimentalFifty adult cancer patients with obesity (BMI ≥30 kg/m²) newly diagnosed with stage II-IV solid tumors undergoing curative-intent treatment. Participants will receive a multimodal weight management program combining dietary intervention, physicial activity and behavioral support.
Receives: Behavioral: Multimodal weight management program

What is being measured

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

  1. Accrual

    Feasibility will be evaluated based on participant accrual, measured by the weekly enrollment rate and the total duration required to achieve the target sample size.

    Measured: From baseline to end of cancer treatment (3 to 9 months)

  2. Retention

    Feasibility will be assessed based on participant retention, monitored through attendance records signed at each visit. Investigators will calculate the retention rate, dropout rate, time to dropout, and reasons for discontinuation.

    Measured: From baseline to end of cancer treatment (3 to 9 months)

  3. Fidelity of the programme delivery

    Feasibility based on fidelity of the intervention will be assessed using a patient-completed checklist after each dietetic and physiotherapy session. Items will be scored as: +1: session content delivered as intended, 0: content omitted, -1: content delivered in a way that deviates from protocol.

    Fidelity scores will be aggregated, and if overall fidelity drops below 80%, retraining may be considered. Additionally, patients will complete a final evaluation form at the end of the program assessing intervention load, frequency, delivery format, behavioral support, and perceived value (e.g., effort, satisfaction, willingness to repeat).

    Measured: From baseline to end of cancer treatment (3 to 9 months)

  4. Nutritional adherence

    Feasibility based on adherence will be evaluated using a 24-hour dietary recall to assess energy and protein intake. At the end of the intervention period, dietary adherence will also be defined as a 10-20% reduction in baseline calorie intake, along with maintenance or an increase in protein intake.

    Measured: From baseline to end of cancer treatment (3 to 9 months)

  5. Physical activity adherence

    Feasibility based on physical activity adherence will be assessed through physiotherapist evaluations and wearable device tracking.

    Measured: From baseline to end of cancer treatment (3 to 9 months)

  6. Ocurrance of any serious or life-threatening adverse events (Safety)

    Safety will be evaluated by monitoring the occurrence of any serious or life-threatening adverse events that may be attributable to the intervention. Specifically, investigators will record physical or cardiac events resulting in overnight hospitalization. The clinical team will assess and document whether each event is related to the dietary, exercise, or behavioral components of the intervention.

    Measured: Throughout the study period (from baseline to end of intervention, 3 to 9 months)

Secondary outcomes (5)

  1. Change in Body Weight and Body Composition

    Assessed by bioelectrical impedance analysis (BIA, InBody S10) at each dietetic visit. Measures include total weight change (kg), fat mass (kg), and preservation of muscle mass. In patients with available imaging, body composition will be analyzed using CT scan at the L3 vertebral level.

    Measured: Baseline to end of treatment (approx. 3 to 9 months)

  2. Change in Eating Self-Efficacy

    Eating self-efficacy will be assessed using the scenario-based Dieting Self-Efficacy Scale (DIET-SE), consisting of 11 items evaluating confidence in managing challenges to dietary self-control. Responses to each item are assessed on a Likert-type rating scale ranging from 0 (not at all confident) to 4 (very con-fident).

    Measured: Baseline to the end of intervention (approx. 3 to 9 months)

  3. Change in physical activity self-efficacy

    Exercise self-efficacy will be assessed using the modified Physical Activity Self-Efficacy Scale. A five-point Likert scale ranging from not at all confident (1) to very confident (5) will be used, higher scores indicating greater self-efficacy. Assessments will be conducted at baseline and at the end of the intervention.

    Measured: Baseline to the end of intervention (approx. 3 to 9 months)

  4. Change in Autonomous Motivation

    Autonomous motivation will be assessed using an adapted and abbreviated version of the Treatment Self-Regulation Questionnaire (TSRQ). This scale includes four items rated on a 5-point Likert scale ranging from 1 ("not at all true") to 5 ("very true"). Higher scores indicate greater autonomous motivation toward behavior change. One-to-one psychological support may be offered to participants with low scores to enhance engagement.

    Measured: Baseline to the end of intervention (approx. 3 to 9 months)

  5. Modified Glasgow Prognostic Score

    Serum albumin and C-reactive protein levels will be used to calculate the Modified Glasgow Prognostic Score (mGPS) as a measure of systemic inflammation. Blood samples will be collected at baseline and at the end of the intervention, coinciding with routine clinical assessments.

    Measured: Baseline and end of treatment (3 to 9 months)

Timeline

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

  1. First posted10 Jul 2025
  2. Study start22 Jul 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionMar 2027 (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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm intervention study designed to assess feasibility, accrual rate, retention, compliance and safety of a multimodal weight management program in obese cancer patients undergoing curative treatment.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07058207
Sponsor's protocol ID
PR079/25
Acronym
CANOBESE
Status last verified
Jul 2025
First submitted
10 Jun 2025
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Llenas-Blade A, Puig Figueras M, Padilla Padilla C, Esteve A, Zamora-Ros R, Daura I Vidal M, Ochoa-Arnedo C, Pernas S, Santos Vivas C, Brenes J, Jimenez-Colomo L, Asiain L, Nadal E, Arribas L. Weight management in obese cancer patients during curative active treatment: protocol for the CANOBESE feasibility study. Pilot Feasibility Stud. 2026 Jun 24. doi: 10.1186/s40814-026-01868-w. Online ahead of print.

    PubMed 42343485

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal weight management program in people with Obesity and Solid Neoplasm, run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Spain.

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 13 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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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 Lorena Arribas (+34932607751, larribas@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accrual (time frame: From baseline to end of cancer treatment (3 to 9 months)). The study lists 6 primary outcomes in all. 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 NCT07058207, which also lists 1 linked publication.

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 28 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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