NCT04136249

Brief Summary

This study is based on the assumption that muscle strength and muscle mass will be better preserved in an "intervention" group with specific management combining retraining and nutritional monitoring compared to the "no intervention" group and that this will be positive consequences for fatigue and quality of life. In addition, this project is also based on the assumption that these gains will be at least partially preserved 3 months after the end of specific care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

November 2, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

March 10, 2020

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

October 21, 2019

Last Update Submit

March 9, 2020

Conditions

CancerCachexia; Cancer

Keywords

cancercachexianutritionphysical exercice

Outcome Measures

Primary Outcomes (1)

  • Isometric force

    This objective will be evaluated using an isometric ergometer and the force will be expressed in Newtons. This parameter will be analyzed using a mixed linear model adjusted to the group and clinically relevant factors.

    3 months

Study Arms (2)

Control chimiotherapeutic arm

NO INTERVENTION

Standard care as comparaison procedure that includes chemotherapy

Physical over-activity

EXPERIMENTAL

The procedure under study which includes a re-training mixing EMS and EXC with a nutrition adapted to the needs related to the physical over-activity following the chemotherapy

Dietary Supplement: Over physical activity

Interventions

Over physical activityDIETARY_SUPPLEMENT

105/5000 resistance training combined with nutritional monitoring on maximum strength of knee extensors

Physical over-activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient, male or female, over 18 years old
  • Patient operated on for a first colorectal cancer (adenocarcinoma) and requiring adjuvant chemotherapy
  • Patient with the consent of a physician to participate in the innovative muscle building program
  • Patient able to go at least once a week for 12 weeks to the Private Hospital of the Loire in Saint-Etienne (the other 2 weekly sessions that can take place in the patient's home)
  • Patient affiliated or beneficiary of a social security scheme
  • Patient having signed the free and informed consent

You may not qualify if:

  • Comorbidities potentially affecting participation or test results (unstable, neuromuscular, musculoskeletal or vascular diseases affecting the lower limbs, such as radiculopathy, myopathy or neuropathy)
  • Technical necessity to convert laparoscopy into laparostomy
  • Patient unable to follow verbal instructions that could affect test and / or exercise procedures
  • Patient participating in another clinical study
  • Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, lactating or parturient woman
  • Patient hospitalized without consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé de la Loire 39

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42100, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsCachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Central Study Contacts

Jean-François OUDET

CONTACT

0683346567

Marie Barba

CONTACT

+330664888704mh.barba@ecten.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

November 2, 2019

Primary Completion

November 30, 2021

Study Completion

April 30, 2022

Last Updated

March 10, 2020

Record last verified: 2019-10

Locations

FR(1)