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Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention

Phase 3
18 Years
Not Enrolling
Cancer, Malignant Wounds

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Trial Information

Malignant Wounds: A Randomized Clinical Trial Investigating a Complementary Multidimensional Intervention

Objective: To investigate whether treatment for cancer patients with malignant wounds can
improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the
effects of two multidimensional interventions:

1. wound treatment (silver product, alginate and foam dressing >< honey product, alginate
and foam dressing) in combination with,

2. psycho-social support (based on the structure in cognitive therapy) and

3. relaxation therapy.

Furthermore to investigate coping strategies, body image, stigma and quality of life in
cancer patients with malignant wounds.

Design: A hypothesis testing prospective randomized clinical intervention study (n=70) and
an explorative qualitative interview study

Method: Digital photographing, measurement of wound size with Quantify-Image-One, wound
morphology registration (the extent of malodour, infection, seepage, bleeding, pain, the
healing process), grafting, VAS-score, quality of life questionnaire (EORTC-QLQ-C30, DLQI),
Hospital Anxiety and Depression Scale (HAD), Mental Adjustment to Cancer (MAC), interview.

Patients will fill out a diary focusing on wound related problems.

Perspectives: The results will determine whether the honey treatment is an improvement, and
whether the silver treatment has statistical and clinical significance.

The qualitative study will contribute new knowledge about conditions of life for cancer
patients with cancer wounds, their feelings and impositions.

In spite of proving positive effect, the project will contribute with new required knowledge
on treatment and support for cancer patients suffering from malignant wounds.

Inclusion Criteria:

- Cancer with evidence of disease.

- Cancer wound >2 cm.

- Receiving antineoplasm treatment.

- > 18 years.

- Receiving antineoplasm treatment in out-patient clinic.

- Read, speak and write Danish.

Exclusion Criteria:

- No radiation therapy the last 6 month (on the wound).

- Life expectancy > 3 month.

- Not psychotic.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Wound size

Outcome Time Frame:

after four weeks intervention period

Safety Issue:


Principal Investigator

Lis Adamsen, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Copenhagen University. Faculty of health Sciences, Denmark


Denmark: Danish Dataprotection Agency

Study ID:

kf 0102006-5491



Start Date:

April 2007

Completion Date:

May 2009

Related Keywords:

  • Cancer
  • Malignant Wounds
  • Cancer
  • Malignant wounds
  • Quality of life
  • Body-Image
  • Cancer patients