Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Breast Neoplasms

Lymphedema

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

Liposuction is performed on the abdomen or thighs.

Liposuction

30mL harvested lipoaspirate is injected at the affected axillary site.

Fat graft

30mL saline is injected at the affected axillary site.

Sham graf (Saline injection)

4mL stem cell suspension injected at the affected axillary site.

Stem cell injection

4mL saline injected at the affected axillary site.

Saline injection

Jens A Sørensen, MD, PhD

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.

All patients undergo the same liposuction procedure. During general anesthesia, patients are randomized to either fat grafting or sham grafting with saline injection to the axilla. After stem cell suspension, patients receive either stem cell or saline injection depending on randomization using masked syringes.

Participants are blinded, care providers postoperatively are blinded, primary investigator is blinded and all outcome assessors are blinded. The surgeon performing the liposuction and the stem-cell staff are unblinded.

Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

Assessed using clinical circumference measurement

Any side effects to treatments. Assessed by asking the patient at each visit.

Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.

Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered

Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.

Change in lymph drainage assessed by indocyanine-green lymphangiography

Change in use or type of conservative lymphedema treatments

Change in infection rates and sick-days due to lymphedema.

Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.

Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.

Odense University Hospital

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Constriction, Pathologic

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

The fat grafting procedure will be conducted as per local standard RM protocol. All procedures will be conducted by the study Principal Investigator (PI) who is well practiced in performing this procedure in Head \& Neck and breast cancer patients and also in scar revision patients.

Fat Graft

Mark Brandon-Grove

Marielle Ms Nobbenhuis

The GRASS study looks at performing a technique called "Fat Tissue Grafting" to assess whether it can reduce the side effects of vaginal stenosis effects and improve the sexual function of participants who wish to preserve penetrative sexual function

Vaginal stenosis is a common sequelae of radiotherapy treatment for cervical cancer. This can cause significant sexual problems resulting in sexual avoidance, relationship problems, feelings of low self-esteem, isolation, and difficulties initiating new relationships. Vaginal changes resulting in narrowing (stenosis) and adhesions can also lead to painful vaginal examinations which are routinely performed during follow-up consultations.

The available treatments for vaginal problems include regular use of vaginal dilators, lubricants, and moisturisers, all of which have shown poor results despite requiring an incessant effort by women.

A technique called 'fat grafting' has been successfully and safely used for many years to rectify the cosmetic and functional consequences of Breast and Head and Neck Cancers treatments. This technique is performed under general anaesthesia and uses fat tissue that is removed from other parts of the body; usually thighs, abdomen, and buttocks, by liposuction. The fat tissue is then processed into liquid and injected into the required area to generate more elasticity and improve tissue quality. To our knowledge this technique has never been applied to the field of Gynaecology-oncology.

In 2021 this technique was used in one patient with severe vaginal stenosis after radiotherapy treatment for advanced cervical cancer, by the Gynaecological and Plastic surgical teams at the Royal Marsden Hospital (RM). The fat tissue was harvested and processed using the method as described and injected into the vagina area (rectovaginal wall) with the aim being to generate more elasticity and improve the quality of the vaginal tissue. As a result of the procedure, the patient now reports reduction in vaginal bleeding and pain experienced, and a noticeable improvement in the size of the vagina allowing for penetrative sex.

This innovative technique addresses a neglected and unmet need of women to manage a consequence of curative treatment that is underreported and often unrecognised. It also serves as an example of how cross-discipline work focused on real patients' needs can produce ground-breaking solutions to complex clinical conundrums, by mobilising highly specialist clinical experts.

If this programme is successful, it can be expanded to women with vaginal stenosis due to radiotherapy for other cancers e.g., colorectal, or urological cancer. In addition, the investigators the investigators will work in partnership with the patient(s) who successfully benefit from fat grafting treatment to guide the development of a larger study.

Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer

Using Fat Tissue GRafting to Treat Symptoms of VAginal Stenosis in Women With Gynaecological Cancer - IDEAL Stage 2a Surgical Study

Ability to have vaginal penetration , this is descriptive and will be provided as a yes / no answer by the patient at their follow up visit

Increase in the volume of the rectovaginal septum on pelvic MRI imaging

Fat:Fibrosis ratio and total far and fibrosis percentage (as a percentage of the total stroma)

Measured using the Sexual Well-Being After Cervical or Endometrial Cancer (SWELL-CE) questionnaire (11) - a score drop below 9 (a score of 9 or above represents significant sexual difficulties)

Cervical cancer specific quality of life measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-CX24 - 10% improvement of the scale range for MCID (minimally clinically important differences)

Overall quality of life measured using the EORTC QLQ-C30. Any improvement in overall score will be deemed as an improvement

Overall quality of life measured using the EUROQOL EQ-5D-5L. Any improvement in overall score will be deemed as an improvement

Occurrence of Calvien Dindo complications (≥grade 3 ) post treatment

Determination of patient acceptability of the research procedure and of the trial will be explored in a focus group

Number of patients screened eligible, number approached and number of patients who consent to take part

Assess the proportion of patients who complete each planned fat graft treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting	NCT03776721	Lymphedema	Liposuction Fat graft Sham graf (Sali... Stem cell injec... Saline injectio...	18 Years -	Odense University Hospital
Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer	NCT06015360	Cervical Cancer	Fat Graft	-	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for fat graft

Every month we try and update this database with for fat graft cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fat graft

Every month we try and update this database with for fat graft cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fat graft cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.