Physically Active During Cancer Treatment (FAKT)

NCT03885817 | Active Not Recruiting

• 1 other identifier: 2015/1050
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 5

Brief Summary

This randomized controlled trial aims to investigate whether an individually tailored exercise program and nutritional guide can affect the development of self-reported peripheral sensory neuropathy and fatigue in patients with colorectal cancer receiving adjuvant chemotherapy.

Conditions

Neoplasms, Colorectal

Keywords

Exercise therapy; Fatigue; Adjuvant chemotherapy; Peripheral neuropathy, chemotherapy induced; Nutritional guide

Outcome Measures

Primary Outcomes (1)

• Patient reported peripheral sensory neuropathy

  The 9-item European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Chemotherapy Induced Peripheral Neuropathy (CIPN20) sensory subscale will be used to measure sensory neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 9 to 36. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).

  Baseline to 3 months

Secondary Outcomes (27)

• Fatigue

  Baseline to 3, 6, 9, 12, 24 and 36 months

• Change in patient reported peripheral sensory neuropathy.

  Baseline to 3, 6, 9, 12, 24 and 36 months

• Change in patient reported motor neuropathy

  Baseline to 3, 6, 9, 12, 24 and 36 months

• Change in patient reported autonomic neuropathy

  Baseline to 3, 6, 9, 12, 24 and 36 months

• Clinicians reported neuropathy

  Baseline to 3, 6 and 12 months.

Other Outcomes (4)

• Serious adverse events (SAE)

  Baseline to 6 months

• Patient's expectations and experiences

  Baseline, 3 and 6 months

• Medical treatment for hypertension.

  Baseline, 3, 6 and 12 months

Study Arms (2)

Exercise training and nutritional guide

EXPERIMENTAL

Standard recommendations regarding physical activity and nutrition. An individually tailored exercise program and nutritional guide during adjuvant chemotherapy.

Behavioral: Exercise training and nutritional guide; Other: Standard follow-up care

Standard follow-up care

ACTIVE COMPARATOR

Standard recommendations regarding physical activity and nutrition.

Other: Standard follow-up care

Interventions

Exercise training and nutritional guide BEHAVIORAL

30 minutes of a combination of sensorimotor- and strength training guided by a physical therapist twice a week. In addition 90 minutes a week of moderate intensity aerobic training or 45 minutes a week of high intensity aerobic training. Once a month the participants will fill out the form, PG-SGA SF, and he or she will be referred to a nutritionist if the score is 2 or higher. The intervention period lasts as long as the participants receives adjuvant chemotherapy, i.e. 3 - 6 months.

Exercise training and nutritional guide

Standard follow-up care OTHER

standard recommendations regarding physical activity and nutrition during the period with adjuvant chemotherapy.

Exercise training and nutritional guide; Standard follow-up care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radical resection for colon- or rectal cancer past 3 months, and scheduled for adjuvant, Oxaliplatin-based, combination chemotherapy.
• Histologically confirmed adenocarcinoma.
• Able to read and understand Norwegian.
• Able to carry out the intervention.
• Performance Status (PS) 0 - 2.

You may not qualify if:

• Serious comorbidities that contraindicate physical exercise, based on the treating physician's assessment.
• Unable to give informed consent.
• Prior treatment with Oxaliplatin

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Alesund Hospital: collaborator
• Helse Nord-Trøndelag HF: collaborator
• Ullevaal University Hospital: collaborator
• Sorlandet Hospital HF: collaborator
• Asker & Baerum Hospital: collaborator
• Haukeland University Hospital: collaborator

Study Sites (5)

Ålesund sjukehus

Ålesund, Norway

Location

Sørlandet sykehus, Kristiansand

Kristiansand, Norway

Location

Levanger sykehus

Levanger, Norway

Location

Ullevål

Oslo, Norway

Location

Kreftklinikken, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• Hatlevoll I, Oldervoll LM, Wibe A, Stene GB, Stafne SN, Hofsli E. Physical exercise during adjuvant chemotherapy for colorectal cancer-a non-randomized feasibility study. Support Care Cancer. 2021 Jun;29(6):2993-3008. doi: 10.1007/s00520-020-05789-z. Epub 2020 Oct 8.

  PMID: 33030598 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Fatigue; Peripheral Nervous System Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Arne Solberg, md phd

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: March 22, 2019
• Study Start: March 27, 2019
• Primary Completion: September 13, 2022
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)