This pilot study will be performed to determine the feasibility and effectiveness of a multimodal revalidation program prior to and during adjuvant chemotherapy in patients with stage 3 colon carcinoma.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility will be evaluated by:
- safety: occurance of side effects/complications as a result of the
intervention
- adherence of the intervention by patients
- fidelity of the intervention by fysiotherapists
- satisfaction of both patients as fysiotherapists
- practicability of the intervention
- implementability of the intervention
Potential effectiveness will be evaluated by
1. Self-reported functional recovery: difference in physical activity between
start and end of revalidation program
2. Observed functional recovery: difference between start and end of
revalidation program in quality of life, performance status, fatigue, short
physical perforamce battery, maximal exertion, muscle strength, anthropometry,
fat-free body mass, nutritional status
3. Time between surgical procedure and start of adjuvant chemotherapy
4. Side effects of adjuvant chemotherapy
5. Compliance of adjuvant chemotherapy
Secondary outcome
Not applicable
Background summary
In the Netherlands, each year 5,000 people are diagnosed with colon carcinoma
with lymph node metastases. These so-called stage 3 colon carcinoma patients
require adjuvant chemotherapy to improve survival rates. If this adjuvant
chemotherapy cannot be started in time or cannot be fully completed, 5-year
survival rates decrease from 75% to 39%. Due to the high risk of complications
after surgery (approximately 30-60%), postoperative recovery is often delayed.
As a result, in only 50% of patients adjuvant chemotherapy is started in time.
Moreover, 50% of the patients undergoing adjuvant chemotherapy drop out or
receive a dose reduction due to side effects. Research has shown that
optimizing the condition by a multimodal program prior to surgery
(prehabilitation) increases a patient*s resilience to withstand surgery. As a
results, postoperative complication rates decrease and functional recovery
enhances. By analogy, it can be suggested that a comparable program after
surgery both ensures patients to start chemotherapy in time and ensures
patients to better tolerate adjuvant chemotherapy.
Study objective
This pilot study will be performed to determine the feasibility and
effectiveness of a multimodal revalidation program prior to and during adjuvant
chemotherapy in patients with stage 3 colon carcinoma.
Study design
This pilot study will be conducted in Noordwest Ziekenhuisgroep location
Alkmaar. 15-20 patients with stage 3 colon carcioma eligible for treatment with
adjuvant chemotherapy will be included. Included patients will undergo a
multimodal revalidation program including high intensity interval training
prior to and during adjuvant chemotherapy.
Study burden and risks
Patients will undergo a multimodal revalidation program prior to and during
adjuvant chemotherapy. Patients will perform high intensity interval training
and resistance training under supervision of a physiotherapist. The content of
the training will be adjusted to a patient's condition and can be adjusted
throughout the revalidation program. Physiotherapists are trained to anticipate
complex problems in patients with cancer. The high intensity of this
revalidation program might be considered as a burden for the patients. However,
we know from prehabilitation, in which patiens undergo a training program with
similar intensity, that increasing their fitness is of such value that patients
do not perceive the high intensity as a high load.
Geert Grooteplein Zuid 10 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Adult patients (>18 years) with stage 3 colon carcinoma eligible for treatment
with adjuvant chemotherapy
Exclusion criteria
Patients <18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL73776.091.20 |