Recruiting nowNot phasedRandomised
| Registry number | NCT07534852 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 120 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Supplement Standard hypercaloric-hyperproteic nutritional supplementation
- Supplement HMB-enriched hypercaloric-hyperproteic nutritional supplementation with vitamin D and calcium
- Behavioural Supervised exercise program
- Behavioural General physical activity recommendations
What it is measuring
Change in phase angle (PhA)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
The goal of this study is to evaluate the effects of nutritional supplementation and physical activity interventions on recovery, muscle strength, nutritional status, inflammation, and metabolic health in adults with colon cancer undergoing surgery.
Patients with colon cancer frequently experience loss of muscle mass, reduced physical function, and nutritional deterioration both before and after surgery, which may adversely affect recovery and quality of life.
A key objective of this study is to assess whether a postoperative intervention combining nutritional supplementation with beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, together with a structured physical activity program, can improve muscle strength and functional recovery following colon cancer surgery.
This study aims to answer the following questions:
* Does nutritional supplementation with HMB and vitamin D, combined with postoperative physical activity, improve muscle strength and physical function following colon cancer surgery?
* How do nutritional and lifestyle interventions influence nutritional status, gut microbiota composition, and biological markers of inflammation and metabolism during the recovery period?
* Are there differences in recovery outcomes between patients receiving different types of nutritional support, with or without supervised physical activity?Participants will be adults diagn…
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Adults aged 18 to 75 years.
- Male and female participants.
- Diagnosis of colon cancer at localized or locally advanced stages (TNM stages I-III).
- Patients scheduled for primary surgical treatment.
Exclusion Criteria
- Metastatic disease (stage IV)
- Diagnosis of rectal cancer or tumors involving the rectum
- Prior neoadjuvant chemotherapy or radiotherapy before surgery.
- Presence of synchronous malignant tumors.
- Pregnant or breastfeeding women.
- Presence of severe medical conditions, including acute pancreatitis, severe liver or kidney disease, heart failure, severe pulmonary disease, or peripheral arterial disease affecting the lower limbs.
- Diagnosis of anorexia nervosa or other severe eating disorders.
- Known allergy or intolerance to any nutritional supplements used in the study.
- Medical contraindications to moderate-to-vigorous physical activity.
- Regular participation in high-intensity exercise programs.
- High risk of poor adherence to the study procedures, as determined by the study team.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: Spain.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07534852, registered by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.